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A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

Primary Purpose

Schizophrenia, Bipolar I Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Aripiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Aripiprazole, Aripiprazole Intramuscular Depot, Gluteal Muscle, Long Acting Injection

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A current diagnosis of schizophrenia or bipolar I disorder, as defined by DSM-5 criteria.
  • Body mass index of 18 to 35 kg/m2.
  • On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening.

Exclusion Criteria:

  • Participants who have:

    • Met DSM-5 criteria for substance use disorder within the past 180 days.
    • A positive drug screen for drugs of abuse
  • Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or subjects who use more than one antipsychotic or mood stabilizer(s) medication at screening.
  • Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving IMP. A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants.
  • Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
  • Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations.
  • Participants currently in an acute relapse of schizophrenia.
  • Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, or antisocial personality disorder.
  • Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
  • History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg or anti-HCV, and/or HIV antibodies.
  • Participants deemed intolerant of receiving injections.
  • Participants who have had electroconvulsive therapy within 2 months of administration of IMP.

Sites / Locations

  • Woodland International Research Group
  • Woodland International Research Group
  • CITrials - Bellflower
  • Collaborative Neuroscience Network
  • California Clinical Trials Medical Group
  • Synergy Research Centers
  • NRC Research Institute
  • California Neuropsychopharmacology Clinical Research Institute San Diego
  • Collaborative Neuroscience Network - South Bay
  • Research Centers of America
  • Segal Institute For Clinical Research - West Broward Outpatient Clinic
  • Atlanta Center for Medical Research - Atlanta
  • CBH Health
  • St. Louis Clinical Trials
  • Altea Research Institute - Las Vegas
  • Hassman Research Institute
  • Midwest Clinical Research Center
  • Carolina Clinical Trials
  • Community Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aripiprazole 2M LAI

Aripiprazole 1M depot injection

Arm Description

2 Months (2M) Long-acting injection (LAI). Participants will receive a total of 4 injections of aripiprazole 2M LAI, administered every 56 days (+/- 2 days) from Day 1. Participants will continue to take their current oral antipsychotic or be given 10 to 20 mg oral aripiprazole for 7 days after the first administration.

1 Month (1M) depot injection. Participants will receive a total of 8 injections of aripiprazole 1M depot, administered every 28 days (+/- 2 days) from Day 1. Participants will continue to take their current oral antipsychotic or be given 10 to 20 mg oral aripiprazole for 14 days after the first administration.

Outcomes

Primary Outcome Measures

Number of Participants Reporting One of More Treatment-Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical trial where the participant is administered a medical product; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Number of Participants With a Markedly Abnormal Vital Signs Measurement
Vital signs will include systolic and diastolic blood pressure, heart rate, and body temperature.
Number of Participants With a Markedly Abnormal Electrocardiogram (ECG) Result
The number of participants with any markedly abnormal electrocardiogram (ECG) collected throughout study
Number of Participants With a Markedly Abnormal Clinical Laboratory Assessments
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Number of Participants With a Markedly Abnormal Physical Examinations
The number of participants with any markedly abnormal physical examination results collected throughout study
Mean Change From Baseline in Simpson-Angus Scale Neurologic Rating Scale (SAS)
To assess the extrapyramidal symptoms. The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item will be rated on a 5-point scale, with a score of 1 representing absence of symptoms and a score of 5 representing a severe condition. The cumulative score will range from 10 to 50.
Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
To assess the extrapyramidal symptoms. The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) will be observed unobtrusively while the participant is at rest (eg, in the waiting room), and the investigators will also make global judgments on the participants dyskinesias (items 8 through 10). Each item will be rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, aware/severe distress). The cumulative score will range from 0 to 40.
Mean Change From Baseline in Barnes Akathisia Rating Score (BARS)
To assess the extrapyramidal symptoms. The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items will be rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation will be made on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia.
Mean Change From Baseline in Visual Analog Scale (VAS) Pain Perception Scores After The Last Dose
Participants will assess the perceived pain at the injection site associated with the injection of IMP using a visual analog scale (VAS). Participants randomized to 2M LAI will receive the last dose on Day 169, while participants randomized to 1M depot injection will receive the last dose on Day 197.
Mean Change From Baseline in Investigators Assessment of The Injection Site Score After The Last Dose
The investigators or designees will assess the injection site. Participants randomized to 2M LAI will receive the last dose on Day 169, while participants randomized to 1M depot injection will receive the last dose on Day 197.
Mean Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidality will be monitored during the trial using the C-SSRS. The scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last assessment.
Plasma Concentration of Aripiprazole on Day 225
Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) Post 7th and 8th Dose of Aripiprazole (1M depot injection)
Participants randomized to 1M depot injection will receive the 7th and 8th dose on Days 169 and 197 respectively.
Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) Post Last Dose of Aripiprazole (2M LAI)
Participants randomized to 2M LAI will receive the last dose on Day 169.

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Aripiprazole
Cmax will be measured after the 1st and 4th dose of aripiprazole 2M LAI and after the 1st, 7th and 8th dose of aripiprazole 1M depot injection.
Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole
Tmax will be measured after the 1st and 4th dose of aripiprazole 2M LAI and after the 1st, 7th and 8th dose of aripiprazole 1M depot injection.
Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) Post First Dose of Aripiprazole (1M depot injection)
Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) Post First Dose of Aripiprazole (2M LAI)
Plasma Concentration of Aripiprazole 28 Days (C28) Post First Dose (1M depot injection)
Plasma Concentration of Aripiprazole 56 Days (C56) Post First Dose (2M LAI)
Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) Post Last Dose for Aripiprazole (2M LAI only)
Plasma Concentration of Aripiprazole 28 to 56 Days (C28) Post Last Dose (2M LAI only)
Participants receiving 2M LAI will receive the last dose on Day 169.
Peak-to-Trough Percent Fluctuation (PTF%) After the Last Dose of Aripiprazole
Plasma Concentration of Aripiprazole 14 Days (C14) Post First Dose (1M depot injection)
Plasma Concentration of Aripiprazole 7 Days (C7) Post First Dose (2M LAI)
Change from Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS)
The PANSS consists of 3 subscales containing a total of 30 symptoms constructs developed to asses both the positive and negative symptom of participants with schizophrenia. For each symptom constructs, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The cumulative score ranges from 30 to 210.
Change from Baseline in Clinical Global Impression - Severity Scale (CGI-S)
The CGI-S is a 7-point scale used to measure the severity of illness for each participant. Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Change from Baseline in Clinical Global Impression - Improvement Scale (CGI-I)
The CGI-I scale measures the improvement of illness for each participant. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Change from Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S)
The SWN-S is a participant self-rated scale developed to evaluate the participants perception of well-being while receiving antipsychotic medication. The questionnaire consists of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, and self control). For items marked with a '+', items are rated 1 = not at all to 6 = very much. For items marked with a '-' items are rated 1 = very much to 6 = hardly at all. Total possible scores range from 20-120.
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS measures symptoms of depression and is administered using a structured interview guide. The scale consists of 10 items, each with 7 defined grades of severity (0-6). Total scores ranges from 0-60 and a higher score indicates more depressive symptoms.
Change from Baseline in Young Mania Rating Scale (YMRS)
The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to assess the core symptoms of mania and is based on the participants subjective report of their condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score is summed of 11 items. Total score rage is from 0 to 60 and the higher score represent a worse outcome.
Change from Baseline in Clinical Global Impression - Bipolar Version (CGI-BP)
The CGI-BP scale refers to the global impression of the participants with respect to bipolar disorder. The scale rates the participant's severity of illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and change from preceding phase (CGI-BP change from preceding phase: mania, depression, and overall bipolar illness) based on a 7-point scale from 1 ('normal, not ill') to 7 ('very severely ill').

Full Information

First Posted
July 19, 2019
Last Updated
June 16, 2021
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
PRA Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04030143
Brief Title
A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder
Official Title
A Phase 1b, Open-label, Multiple-dose, Randomized, Parallel-arm, Safety, Tolerability, and Pharmacokinetic Trial of Aripiprazole Intramuscular Depot Administered in the Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
PRA Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole in adult participants with schizophrenia or bipolar I disorder. To establish the similarity of aripiprazole concentrations following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure following the final administration of aripiprazole into the gluteal muscle site.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar I Disorder
Keywords
Aripiprazole, Aripiprazole Intramuscular Depot, Gluteal Muscle, Long Acting Injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole 2M LAI
Arm Type
Experimental
Arm Description
2 Months (2M) Long-acting injection (LAI). Participants will receive a total of 4 injections of aripiprazole 2M LAI, administered every 56 days (+/- 2 days) from Day 1. Participants will continue to take their current oral antipsychotic or be given 10 to 20 mg oral aripiprazole for 7 days after the first administration.
Arm Title
Aripiprazole 1M depot injection
Arm Type
Active Comparator
Arm Description
1 Month (1M) depot injection. Participants will receive a total of 8 injections of aripiprazole 1M depot, administered every 28 days (+/- 2 days) from Day 1. Participants will continue to take their current oral antipsychotic or be given 10 to 20 mg oral aripiprazole for 14 days after the first administration.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Aripiprazole long acting injection.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Aripiprazole depot injection
Primary Outcome Measure Information:
Title
Number of Participants Reporting One of More Treatment-Emergent Adverse Event (TEAE)
Description
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical trial where the participant is administered a medical product; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame
Baseline to Day 225
Title
Number of Participants With a Markedly Abnormal Vital Signs Measurement
Description
Vital signs will include systolic and diastolic blood pressure, heart rate, and body temperature.
Time Frame
Baseline to Day 225
Title
Number of Participants With a Markedly Abnormal Electrocardiogram (ECG) Result
Description
The number of participants with any markedly abnormal electrocardiogram (ECG) collected throughout study
Time Frame
Baseline to Day 225
Title
Number of Participants With a Markedly Abnormal Clinical Laboratory Assessments
Description
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Time Frame
Baseline to Day 225
Title
Number of Participants With a Markedly Abnormal Physical Examinations
Description
The number of participants with any markedly abnormal physical examination results collected throughout study
Time Frame
Baseline to Day 225
Title
Mean Change From Baseline in Simpson-Angus Scale Neurologic Rating Scale (SAS)
Description
To assess the extrapyramidal symptoms. The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item will be rated on a 5-point scale, with a score of 1 representing absence of symptoms and a score of 5 representing a severe condition. The cumulative score will range from 10 to 50.
Time Frame
Baseline to Day 225
Title
Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Description
To assess the extrapyramidal symptoms. The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) will be observed unobtrusively while the participant is at rest (eg, in the waiting room), and the investigators will also make global judgments on the participants dyskinesias (items 8 through 10). Each item will be rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, aware/severe distress). The cumulative score will range from 0 to 40.
Time Frame
Baseline to Day 225
Title
Mean Change From Baseline in Barnes Akathisia Rating Score (BARS)
Description
To assess the extrapyramidal symptoms. The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items will be rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation will be made on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia.
Time Frame
Baseline and Day 225
Title
Mean Change From Baseline in Visual Analog Scale (VAS) Pain Perception Scores After The Last Dose
Description
Participants will assess the perceived pain at the injection site associated with the injection of IMP using a visual analog scale (VAS). Participants randomized to 2M LAI will receive the last dose on Day 169, while participants randomized to 1M depot injection will receive the last dose on Day 197.
Time Frame
2M LAI: Baseline to Day 169; 1M depot injection: Baseline to Day 197
Title
Mean Change From Baseline in Investigators Assessment of The Injection Site Score After The Last Dose
Description
The investigators or designees will assess the injection site. Participants randomized to 2M LAI will receive the last dose on Day 169, while participants randomized to 1M depot injection will receive the last dose on Day 197.
Time Frame
2M LAI: Baseline to Day 169; 1M depot injection: Baseline to Day 197
Title
Mean Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Suicidality will be monitored during the trial using the C-SSRS. The scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last assessment.
Time Frame
Baseline to Day 225
Title
Plasma Concentration of Aripiprazole on Day 225
Time Frame
Day 225
Title
Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) Post 7th and 8th Dose of Aripiprazole (1M depot injection)
Description
Participants randomized to 1M depot injection will receive the 7th and 8th dose on Days 169 and 197 respectively.
Time Frame
0-12 hours post dose on Days 169 and 197, and on Days 170, 171, 173, 176, 178, 181, 183, 186, 190, 198, 199, 201, 204, 206, 209, 211, 214, 218 and 225
Title
Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) Post Last Dose of Aripiprazole (2M LAI)
Description
Participants randomized to 2M LAI will receive the last dose on Day 169.
Time Frame
0-12 hours post dose on Day 169, and on Days 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218 and Day 225
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of Aripiprazole
Description
Cmax will be measured after the 1st and 4th dose of aripiprazole 2M LAI and after the 1st, 7th and 8th dose of aripiprazole 1M depot injection.
Time Frame
2M LAI: 0-12 hours post dose on Day 1 and 169; 1M depot injection: 0-12 hours on Day 1, 169 and 197
Title
Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole
Description
Tmax will be measured after the 1st and 4th dose of aripiprazole 2M LAI and after the 1st, 7th and 8th dose of aripiprazole 1M depot injection.
Time Frame
2M LAI: 0-12 hours post dose on Day 1 and 169; 1M depot injection: 0-12 hours on Day 1, 169 and 197
Title
Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) Post First Dose of Aripiprazole (1M depot injection)
Time Frame
0-12 hours post first dose on Day 1, and Days 2, 3, 5, 8, 10, 13, 15, 18, 22, and 29
Title
Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) Post First Dose of Aripiprazole (2M LAI)
Time Frame
0-12 hours post first dose on Day 1, and Days 2, 3, 5, 8, 10, 13, 15, 18, 22, 29, 36, 43, 50 and 57
Title
Plasma Concentration of Aripiprazole 28 Days (C28) Post First Dose (1M depot injection)
Time Frame
Day 29
Title
Plasma Concentration of Aripiprazole 56 Days (C56) Post First Dose (2M LAI)
Time Frame
Day 57
Title
Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) Post Last Dose for Aripiprazole (2M LAI only)
Time Frame
0-12 hours post last dose on Day 169, and on Days 170, 171, 173, 176, 178, 181, 183, 186, 190, and 197
Title
Plasma Concentration of Aripiprazole 28 to 56 Days (C28) Post Last Dose (2M LAI only)
Description
Participants receiving 2M LAI will receive the last dose on Day 169.
Time Frame
Day 197 to 225
Title
Peak-to-Trough Percent Fluctuation (PTF%) After the Last Dose of Aripiprazole
Time Frame
2M LAI: 0-12 hours post dose on Day 169, and at multiple time points from Day 170 to Day 255; 1M depot injection: 0-12 hours post dose on Day 197 and at multiple timepoints from Day 198 to 225
Title
Plasma Concentration of Aripiprazole 14 Days (C14) Post First Dose (1M depot injection)
Time Frame
Day 15
Title
Plasma Concentration of Aripiprazole 7 Days (C7) Post First Dose (2M LAI)
Time Frame
Day 8
Title
Change from Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS)
Description
The PANSS consists of 3 subscales containing a total of 30 symptoms constructs developed to asses both the positive and negative symptom of participants with schizophrenia. For each symptom constructs, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The cumulative score ranges from 30 to 210.
Time Frame
Baseline to Day 225
Title
Change from Baseline in Clinical Global Impression - Severity Scale (CGI-S)
Description
The CGI-S is a 7-point scale used to measure the severity of illness for each participant. Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Time Frame
Baseline to Day 225
Title
Change from Baseline in Clinical Global Impression - Improvement Scale (CGI-I)
Description
The CGI-I scale measures the improvement of illness for each participant. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Time Frame
Day 57 to Day 225
Title
Change from Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S)
Description
The SWN-S is a participant self-rated scale developed to evaluate the participants perception of well-being while receiving antipsychotic medication. The questionnaire consists of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, and self control). For items marked with a '+', items are rated 1 = not at all to 6 = very much. For items marked with a '-' items are rated 1 = very much to 6 = hardly at all. Total possible scores range from 20-120.
Time Frame
Baseline to Day 225
Title
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Description
The MADRS measures symptoms of depression and is administered using a structured interview guide. The scale consists of 10 items, each with 7 defined grades of severity (0-6). Total scores ranges from 0-60 and a higher score indicates more depressive symptoms.
Time Frame
Baseline to Day 225
Title
Change from Baseline in Young Mania Rating Scale (YMRS)
Description
The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to assess the core symptoms of mania and is based on the participants subjective report of their condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score is summed of 11 items. Total score rage is from 0 to 60 and the higher score represent a worse outcome.
Time Frame
Baseline to Day 225
Title
Change from Baseline in Clinical Global Impression - Bipolar Version (CGI-BP)
Description
The CGI-BP scale refers to the global impression of the participants with respect to bipolar disorder. The scale rates the participant's severity of illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and change from preceding phase (CGI-BP change from preceding phase: mania, depression, and overall bipolar illness) based on a 7-point scale from 1 ('normal, not ill') to 7 ('very severely ill').
Time Frame
Baseline to Day 225

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A current diagnosis of schizophrenia or bipolar I disorder, as defined by DSM-5 criteria. Body mass index of 18 to 35 kg/m2. On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening. Exclusion Criteria: Participants who have: Met DSM-5 criteria for substance use disorder within the past 180 days. A positive drug screen for drugs of abuse Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or subjects who use more than one antipsychotic or mood stabilizer(s) medication at screening. Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving IMP. A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants. Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial. Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations. Participants currently in an acute relapse of schizophrenia. Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, or antisocial personality disorder. Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia. History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones. History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg or anti-HCV, and/or HIV antibodies. Participants deemed intolerant of receiving injections. Participants who have had electroconvulsive therapy within 2 months of administration of IMP.
Facility Information:
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland International Research Group
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
CITrials - Bellflower
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
California Clinical Trials Medical Group
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Synergy Research Centers
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Neuropsychopharmacology Clinical Research Institute San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Collaborative Neuroscience Network - South Bay
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Segal Institute For Clinical Research - West Broward Outpatient Clinic
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Atlanta Center for Medical Research - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
CBH Health
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
St. Louis Clinical Trials
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Altea Research Institute - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Carolina Clinical Trials
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Community Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
IPD Sharing URL
https://clinical-trials.otsuka.com

Learn more about this trial

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

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