Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054702
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : December 1, 2015
Last Update Posted : December 30, 2015
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Brexpiprazole
Drug: Aripiprazole
Enrollment 97
Recruitment Details The trial was conducted in 97 participants at 19 trial sites in United States.
Pre-assignment Details The trial consisted of a 2- to 14-day screening phase, a 6-week treatment phase, and a 30-day follow-up phase.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description Participants were administered brexpiprazole tablets orally, once daily (QD) starting dose at 1 milligram per day (mg/day) for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6. Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Period Title: Overall Study
Started 64 33
Completed 40 21
Not Completed 24 12
Reason Not Completed
Lost to Follow-up             3             5
Adverse Event             3             1
Met Withdrawal Criteria             4             1
Physician Decision             0             1
Withdrawal by Subject             14             4
Arm/Group Title Brexpiprazole Arpiprazole Total
Hide Arm/Group Description Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6. Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6. Total of all reporting groups
Overall Number of Baseline Participants 64 33 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 33 participants 97 participants
42.2  (10.1) 42.1  (10.4) 42.2  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 33 participants 97 participants
Female
18
  28.1%
10
  30.3%
28
  28.9%
Male
46
  71.9%
23
  69.7%
69
  71.1%
1.Primary Outcome
Title Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a mixed model repeated measures (MMRM) analysis with an unstructured variance covariance structure.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-22.9  (1.7) -19.4  (2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis is mean change in PANSS total score from baseline to week 6 for brexpiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Statistical analysis is mean change in PANSS total score from baseline to week 6 for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
2.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery Composite Score
Hide Description The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Least Squares Mean (Standard Error)
Unit of Measure: z-score
0.045  (0.056) -0.024  (0.081)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for brexpiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4244
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7623
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
3.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery of Early Phase Battery Score
Hide Description The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Least Squares Mean (Standard Error)
Unit of Measure: z-score
-0.010  (0.063) 0.113  (0.091)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8759
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2176
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
4.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)
Hide Description The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Least Squares Mean (Standard Error)
Unit of Measure: z-score
0.7  (3.7) -4.6  (5.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for brexpiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8420
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole, Aripiprazole
Comments Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3781
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
5.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery Scores of Detection Task
Hide Description The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Least Squares Mean (Standard Error)
Unit of Measure: z-score
0.024  (0.018) -0.029  (0.026)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for brexpiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1807
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2802
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
6.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery Scores of Identification Task
Hide Description The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Least Squares Mean (Standard Error)
Unit of Measure: z-score
-0.002  (0.011) -0.011  (0.016)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for brexpiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8622
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4848
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
7.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task
Hide Description The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Least Squares Mean (Standard Error)
Unit of Measure: z-score
0.003  (0.018) 0.000  (0.027)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for brexpiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8588
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9928
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
8.Secondary Outcome
Title Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
Hide Description The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 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 Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.6  (0.1) -1.3  (0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis is mean change in CGI-S from baseline to week 6 for brexpiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Statistical analysis is mean change in CGI-S from baseline to week 6 were observed for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.
9.Secondary Outcome
Title Mean Change in Clinical Global Impression-Improvement (CGI-I) Score at Week 6
Hide Description The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.5  (0.9) 2.7  (1.0)
10.Secondary Outcome
Title Response Rate by Study Week
Hide Description The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved).
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Measure Type: Number
Unit of Measure: percentage of participants
60.9 48.5
11.Secondary Outcome
Title Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score
Hide Description The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject's quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 "not well at all" to 5 "very well". The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
7.5
(4.0 to 10.9)
6.0
(1.2 to 10.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis is mean change in SLOF total score from baseline to week 6 for brexpiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments The analysis of covariance (ANCOVA) model with treatment group and total score at baseline as covariate was used for change from baseline comparisons.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Statistical analysis is mean change in SLOF total score from baseline to week 6 for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.
12.Secondary Outcome
Title Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score
Hide Description The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description:
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
Overall Number of Participants Analyzed 64 33
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-2.6
(-5.0 to -0.1)
-0.1
(-3.5 to 3.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for brexpiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0392
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9716
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.
Time Frame Adverse events were reported from the signing of informed consent throughout the 6-week treatment period until the follow-up visit 30 days (+2) after the last dose of study medication.
Adverse Event Reporting Description Participants with adverse events were counted only once towards the total.
 
Arm/Group Title Brexpiprazole Aripiprazole
Hide Arm/Group Description Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6. Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
All-Cause Mortality
Brexpiprazole Aripiprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Brexpiprazole Aripiprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   3/64 (4.69%)   1/33 (3.03%) 
Infections and infestations     
Acute hepatitis B * 1  1/64 (1.56%)  0/33 (0.00%) 
Nervous system disorders     
Convulsion * 1  1/64 (1.56%)  0/33 (0.00%) 
Presynscope * 1  0/64 (0.00%)  1/33 (3.03%) 
Psychiatric disorders     
Schizophrenia * 1  1/64 (1.56%)  0/33 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brexpiprazole Aripiprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   36/64 (56.25%)   21/33 (63.64%) 
Gastrointestinal disorders     
Dry mouth * 1  5/64 (7.81%)  2/33 (6.06%) 
Dyspepsia * 1  5/64 (7.81%)  3/33 (9.09%) 
Nausea * 1  4/64 (6.25%)  1/33 (3.03%) 
Constipation * 1  3/64 (4.69%)  3/33 (9.09%) 
Diarrhoea * 1  3/64 (4.69%)  2/33 (6.06%) 
Toothache * 1  0/64 (0.00%)  2/33 (6.06%) 
Investigations     
Weight increased * 1  6/64 (9.38%)  3/33 (9.09%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  4/64 (6.25%)  1/33 (3.03%) 
Back pain * 1  2/64 (3.13%)  2/33 (6.06%) 
Muscle spasm * 1  0/64 (0.00%)  2/33 (6.06%) 
Nervous system disorders     
Akathisia * 1  6/64 (9.38%)  7/33 (21.21%) 
Headache * 1  5/64 (7.81%)  4/33 (12.12%) 
Sedation * 1  0/64 (0.00%)  2/33 (6.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02054702    
Other Study ID Numbers: 331-13-008
First Submitted: February 2, 2014
First Posted: February 4, 2014
Results First Submitted: August 5, 2015
Results First Posted: December 1, 2015
Last Update Posted: December 30, 2015