Back to resultsOpen-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole IM Depot
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects 18 to 66 years of age, inclusive, at the time of informed consent.
- Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
- Ability, in the opinion of the investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
- Subjects who have met the completion criteria in the 31-12-291 registrational trial for the acute treatment of adults with schizophrenia
- Subjects who, in the investigator's judgment, require chronic treatment with antipsychotic medication and would benefit from extended treatment with an IM depot formulation.
- Outpatient status at the Week 12 in Trial 291, with the exception of those subjects eligible to enter Trial 297 due to a positive interim analysis.
Exclusion Criteria:
- Sexually active males of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 180 days after the last dose of trial medication. Sexually active Women of Childbearing Potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 150 days after the last dose of trial medication.
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP in this trial.
- Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that requires treatment with an antidepressant.
- Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the course of the trial.
- Subjects with a significant risk of violent behavior; who represent a risk of committing suicide; or who in the clinical judgment of the investigator present a serious risk of suicide.
- Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after completion of Trial 291.
- Subjects likely to require prohibited concomitant therapy during the trial
- Laboratory test and ECG results which are exclusionary
- Any subject who, in the opinion of the investigator or medical monitor, should not participate in the trial
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aripiprazole IM Depot
Arm Description
Aripiprazole IM Depot 400 mg or 300 mg once monthly (every 28 days) for 24 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death
A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death.
Secondary Outcome Measures
Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)
Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die,active suicidal thought, active suicidal thought with method, active suicidal thought with intent,active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25.
Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)
The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia.
Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)
EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms.
Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)
The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Patients were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated.
Mean Change in Body Temperature From Baseline in All Participants.
The body temperature, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.
Mean Change in Heart Rate Supine From Baseline in All Participants.
The heart rate supine, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.
Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.
The systolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.
Mean Change in Diastolic Supine BP From Baseline in All Participants.
The diastolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria.
Mean Change in Heart Rate From Baseline in All Participants.
The heart rate sitting, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.
Mean Change in Systolic BP From Baseline in All Participants.
The systolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.
Mean Change in Diastolic BP From Baseline in All Participants.
The diastolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.
Mean Change in Ventricular Rate From Baseline in All Participants.
The measurement ventricular rate is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Mean Change in PR Interval From Baseline in All Participants.
The measurement PR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Mean Change in RR Interval From Baseline in All Participants.
The measurement RR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Mean Change in QRS Interval From Baseline in All Participants.
The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Mean Change in QT Interval From Baseline in All Participants.
The measurement QT interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Mean Change in QTcB Interval From Baseline in All Participants.
The measurement QTcB interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Mean Change in QTcF Interval From Baseline in All Participants.
The measurement QTcF interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Mean Change in QTcN Interval From Baseline in All Participants.
The measurement QTcN interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.
Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.
Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.
Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.
Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.
Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.
Number of Participants With Clinically Relevant Laboratory Values.
The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.
Number of Participants With Clinically Relevant Physical Examination.
The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.
Full Information
NCT ID
NCT01683058
First Posted
September 7, 2012
Last Updated
March 25, 2015
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S, Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01683058
Brief Title
Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
Official Title
A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S, Otsuka America Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at the investigator's discretion, where additional safety and tolerability data will be collected.
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
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aripiprazole IM Depot
Arm Type
Experimental
Arm Description
Aripiprazole IM Depot 400 mg or 300 mg once monthly (every 28 days) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Aripiprazole IM Depot
Intervention Description
Aripiprazole IM Depot 400 mg or 300 mg
Primary Outcome Measure Information:
Title
Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death
Description
A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death.
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die,active suicidal thought, active suicidal thought with method, active suicidal thought with intent,active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25.
Time Frame
Baseline to Week 24
Title
Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)
Description
The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia.
Time Frame
Baseline to Week 24
Title
Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)
Description
EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms.
Time Frame
Baseline to Week 24
Title
Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)
Description
The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Patients were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated.
Time Frame
Baseline to Week 24
Title
Mean Change in Body Temperature From Baseline in All Participants.
Description
The body temperature, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in Heart Rate Supine From Baseline in All Participants.
Description
The heart rate supine, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.
Description
The systolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in Diastolic Supine BP From Baseline in All Participants.
Description
The diastolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in Heart Rate From Baseline in All Participants.
Description
The heart rate sitting, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.
Time Frame
Baseline to last visit
Title
Mean Change in Systolic BP From Baseline in All Participants.
Description
The systolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.
Time Frame
Baseline to last visit
Title
Mean Change in Diastolic BP From Baseline in All Participants.
Description
The diastolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.
Time Frame
Baseline to last visit
Title
Mean Change in Ventricular Rate From Baseline in All Participants.
Description
The measurement ventricular rate is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in PR Interval From Baseline in All Participants.
Description
The measurement PR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in RR Interval From Baseline in All Participants.
Description
The measurement RR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in QRS Interval From Baseline in All Participants.
Description
The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in QT Interval From Baseline in All Participants.
Description
The measurement QT interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in QTcB Interval From Baseline in All Participants.
Description
The measurement QTcB interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in QTcF Interval From Baseline in All Participants.
Description
The measurement QTcF interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in QTcN Interval From Baseline in All Participants.
Description
The measurement QTcN interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.
Description
Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.
Time Frame
Baseline to last visit
Title
Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.
Description
Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.
Time Frame
Baseline to last visit
Title
Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.
Description
Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.
Time Frame
Baseline to last visit
Title
Number of Participants With Clinically Relevant Laboratory Values.
Description
The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.
Time Frame
Baseline to last visit
Title
Number of Participants With Clinically Relevant Physical Examination.
Description
The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.
Time Frame
Baseline to last visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects 18 to 66 years of age, inclusive, at the time of informed consent.
Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
Ability, in the opinion of the investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
Subjects who have met the completion criteria in the 31-12-291 registrational trial for the acute treatment of adults with schizophrenia
Subjects who, in the investigator's judgment, require chronic treatment with antipsychotic medication and would benefit from extended treatment with an IM depot formulation.
Outpatient status at the Week 12 in Trial 291, with the exception of those subjects eligible to enter Trial 297 due to a positive interim analysis.
Exclusion Criteria:
Sexually active males of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 180 days after the last dose of trial medication. Sexually active Women of Childbearing Potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 150 days after the last dose of trial medication.
Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP in this trial.
Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that requires treatment with an antidepressant.
Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the course of the trial.
Subjects with a significant risk of violent behavior; who represent a risk of committing suicide; or who in the clinical judgment of the investigator present a serious risk of suicide.
Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after completion of Trial 291.
Subjects likely to require prohibited concomitant therapy during the trial
Laboratory test and ECG results which are exclusionary
Any subject who, in the opinion of the investigator or medical monitor, should not participate in the trial
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
City
Carson
State/Province
California
ZIP/Postal Code
90746
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
City
North Miami
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
City
Holliswood
State/Province
New York
ZIP/Postal Code
11423
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
City
Popovaca
ZIP/Postal Code
44317
Country
Croatia
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
12. IPD Sharing Statement
Learn more about this trial
Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
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