Back to resultsAssess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SPD489 (Lisdexamfetamine dimesylate)
Placebo
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Subjects must be diagnosed with schizophrenia, on a stable dose of an antipsychotic and not have any cardiac risk factors
Sites / Locations
- California Clinical Trials
- Collaborative Neuroscience Network, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SPD489 (Lisdexamfetamine dimesylate)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 50 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 70 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 100 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 150 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 200 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 250 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Secondary Outcome Measures
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01457339
Brief Title
Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia
Official Title
A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending, Multiple Oral Doses of SPD489 (Lisdexamfetamine Dimesylate) in Clinically Stable Adults With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 21, 2011 (Actual)
Primary Completion Date
January 20, 2012 (Actual)
Study Completion Date
January 20, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPD489 (Lisdexamfetamine dimesylate)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPD489 (Lisdexamfetamine dimesylate)
Other Intervention Name(s)
Vyvanse, LDX
Intervention Description
SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Capsule(s) for oral use taken once daily for 30 days
Primary Outcome Measure Information:
Title
Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Pulse Rate at Day 5: 50 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Pulse Rate at Day 5: 70 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Pulse Rate at Day 5: 100 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Pulse Rate at Day 5: 150 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Pulse Rate at Day 5: 200 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Title
Change From Baseline in Pulse Rate at Day 5: 250 mg
Description
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame
Baseline and day 5
Secondary Outcome Measure Information:
Title
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
Description
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
Description
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
Description
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
Description
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
Description
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
Description
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
Description
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
Description
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
Description
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
Description
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
Description
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
Description
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame
Day 5 (12-hour sampling period post-dose)
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg
Description
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg
Description
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg
Description
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg
Description
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg
Description
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg
Description
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg
Description
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg
Description
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg
Description
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg
Description
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg
Description
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg
Description
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg
Description
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg
Description
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg
Description
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg
Description
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg
Description
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg
Description
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg
Description
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg
Description
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg
Description
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg
Description
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg
Description
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg
Description
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg
Description
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg
Description
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg
Description
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg
Description
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg
Description
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg
Description
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg
Description
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame
Baseline and Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subjects must be diagnosed with schizophrenia, on a stable dose of an antipsychotic and not have any cardiac risk factors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
California Clinical Trials
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia
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