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Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode 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: NCT02013622
Recruitment Status : Completed
First Posted : December 17, 2013
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Brexpiprazole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was an exploratory phase 3b, multicenter, open-label, monotherapy, flexible-dose brexpiprazole trial designed to assess the efficacy and safety of brexpiprazole in participants with early-episode schizophrenia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial consisted of a 2 to 21-day screening phase, a 16-week (112-day) treatment phase, and a 30-day (+2) follow-up phase. The treatment phase was split into a medication conversion period (2, 3, or 4 weeks) and a brexpiprazole monotherapy period (14, 13, or 12 weeks) respectively.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 milligram per day (mg/day) to 4 mg/day, once daily (QD) for 16 Weeks.

Participant Flow:   Overall Study
    Brexpiprazole
STARTED   49 
COMPLETED   25 
NOT COMPLETED   24 
Lost to Follow-up                10 
Adverse Event                3 
Met Withdrawal Criteria                3 
Withdrawal by Subject                6 
Protocol Deviation                1 
Lack of Efficacy                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Baseline Measures
   Brexpiprazole 
Overall Participants Analyzed 
[Units: Participants]
 49 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.1  (5.0) 
Gender 
[Units: Participants]
 
Female   18 
Male   31 


  Outcome Measures

1.  Primary:   Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: Baseline and Week 16 ]

Measure Type Primary
Measure Title Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score
Measure 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 and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The observed case (OC) data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   49 
Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 -10.2  (2.1) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis of zero in mean change from Baseline in PANSS Total Score at Week 16 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Mixed model repeated measures (MMRM) method with model terms: baseline, visit, and baseline by visit interaction.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Secondary:   Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking
Measure 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 negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   49 
Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 -2.0  (0.4) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM method with model terms: baseline, visit, and baseline by visit interaction.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score
Measure 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 and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   49 
Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 -0.6  (0.1) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM method with model terms: baseline, visit, and baseline by visit interaction.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Secondary:   Mean Clinical Global Impression-Improvement (CGI-I) Score   [ Time Frame: Week 1 to Week 16 ]

Measure Type Secondary
Measure Title Mean Clinical Global Impression-Improvement (CGI-I) Score
Measure Description The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” 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. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.
Time Frame Week 1 to Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment, the last observation carried forward (LOCF) dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   48 
Mean Clinical Global Impression-Improvement (CGI-I) Score 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Week 1   3.6  (0.7) 
Week 2   3.1  (1.0) 
Week 3   2.7  (1.1) 
Week 4   2.8  (1.1) 
Week 6   2.7  (1.2) 
Week 8   2.9  (1.2) 
Week 10   2.8  (1.3) 
Week 12   2.8  (1.3) 
Week 14   2.9  (1.3) 
Week 16   2.8  (1.3) 

No statistical analysis provided for Mean Clinical Global Impression-Improvement (CGI-I) Score



5.  Secondary:   CGI-I Response Rate   [ Time Frame: Weeks 4, 8, 12, and 16 ]

Measure Type Secondary
Measure Title CGI-I Response Rate
Measure Description The CGI-I response rate was defined as percentage of participants with CGI-I score of 1 (very much improved) or 2 (much improved).
Time Frame Weeks 4, 8, 12, and 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   48 
CGI-I Response Rate 
[Units: Percentage of participants]
 
Week 4   39.6 
Week 8   35.4 
Week 12   41.7 
Week 16   41.7 

No statistical analysis provided for CGI-I Response Rate



6.  Secondary:   Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score
Measure Description The PSP was used to measure personal and social functioning in 4 domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the study physician's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees, and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   49 
Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 6.6  (1.7) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.0003
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM method with model terms: baseline, visit, and baseline by visit interaction.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



7.  Secondary:   Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score
Measure Description The SLOF questionnaire used in this trial consists of 30 items grouped into 4 areas: social functioning, social acceptability, activities, and work skill. The SLOF scale correlates with a participant's quality of life. Total SLOF scale is sum of these 4 areas score. Each of the questions in the above domains is rated on a 5-point Likert scale. Scores on the instrument range from 30 to 150 with higher scores indicating the better the overall functioning of the patient.
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   49 
Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 13.1  (3.1) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.0002
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM method with model terms: baseline, visit, and baseline by visit interaction.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Secondary:   Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score
Measure Description The PSQI was a self-rated questionnaire that assessed sleep quality and disturbances over a 1-month time interval. Seven domains were measured: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if 1 is available). Only self-rated questions are included in the scoring.The 19 self-rated items are combined to form 7 “component” scores, each of which has a range of 0 - 3 points. In all cases, a score of “0” indicates no difficulty, while a score of “3” indicates severe difficulty. The 7 component scores are then added to yield 1 “global” score, with a range of 0 - 21 points, “0” indicating no difficulty and “21” indicating severe difficulties in all areas.
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   49 
Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 -1.8  (0.7) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.0177
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM method with model terms: baseline, visit, and baseline by visit interaction.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Secondary:   Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score
Measure Description The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM-14 provided scores on 4 domains: effectiveness (questions 1 to 3) side effects (4 to 8), convenience (9 to 11), and global satisfaction (12 to 14). The effectiveness domain was rated on a 7-point scale from “extremely satisfied” to “extremely dissatisfied.” The side effects domain provided an option to skip questions 5 to 8 if the subject provided a negative response to item number 4, ie, “As a result of taking this medication, do you currently experience any side effects at all?” Scores for each domain were transformed into a final score ranging from 0 to 100, with higher numbers indicating a higher level of satisfaction.
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   47 
Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 
Effectiveness   20.00  (4.09) 
Side effects   10.25  (2.98) 
Convenience   11.83  (2.92) 
Global satisfaction   20.67  (4.33) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in TSQM-14 effectiveness
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM method with model terms: baseline, visit, and baseline by visit interaction.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.0031
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in TSQM-14 side effects
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM method with model terms: baseline, visit, and baseline by visit interaction.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.0005
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in TSQM-14 convenience
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM method with model terms: baseline, visit, and baseline by visit interaction.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 4 for Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in TSQM-14 global satisfaction
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM method with model terms: baseline, visit, and baseline by visit interaction.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



10.  Secondary:   Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)
Measure Description Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition. Proportions of inhibitory failures (p-inhibitory failures) is measured as the proportion of no-go targets in the go-cue condition in which a participant failed to inhibit a response.
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   23 
Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures) 
[Units: Failures]
Mean (Standard Deviation)
 
p-inhibition failures (go cues)   0.045  (0.326) 
p-inhibition failures (no-go cues)   0.066  (0.352) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.5133
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (go cues)
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.3774
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (no-go cues)
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



11.  Secondary:   Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)
Measure Description Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition.
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   22 
Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time) 
[Units: Milliseconds]
Mean (Standard Deviation)
 
Mean reaction time (go cues)   -2.05  (68.51) 
Mean reaction time (no-go cues)   -18.77  (90.18) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.8897
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in Go/No-go task mean reaction time (go cues)
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.3401
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in Go/No-go task mean reaction time (no-go cues)
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



12.  Secondary:   Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores
Measure Description Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, "would you prefer $27 today or $50 in 21 days?") The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions.
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   29 
Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores 
[Units: Unitless]
Mean (Standard Deviation)
 0.008520  (0.056857) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.4265
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in DDT
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



13.  Secondary:   Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores
Measure Description Delay discounting measures the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ with completion of an Experiential Discounting task (EDT). The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value:value = A / (1 + hO) p is probability of reward and O is odds against.The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher Probability discounting shows greater impulsivity). A total score is not computed for this task.
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   19 
Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores 
[Units: Unitless]
Mean (Standard Deviation)
 
Delay Discounting Task k value   -103.167142  (414.497480) 
Probability Discounting Task h value   2.866008  (168.230663) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.2923
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in DPDT for Delay Discounting Task k value
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.9416
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in DPDT for Probability Discounting Task h value
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



14.  Secondary:   Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)
Measure Description Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   17 
Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT) 
[Units: Number of Impulsive Choices]
Mean (Standard Deviation)
 8.9  (26.4) 


Statistical Analysis 1 for Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.1815
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in DRT
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



15.  Secondary:   Mean Change From Baseline to Week 16 in Food Delay Discounting Task   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Food Delay Discounting Task
Measure Description Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the "X-axis" is "days", "Y-axis" is "Food value", the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting).
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   18 
Mean Change From Baseline to Week 16 in Food Delay Discounting Task 
[Units: Unitless]
Mean (Standard Deviation)
 0.037  (0.356) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Food Delay Discounting Task
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.6648
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in AUC for food
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline to Week 16 in Food Delay Discounting Task
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.9812
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16 in AUC for money
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



16.  Secondary:   Mean Change From Baseline to Week 16 in Money Delay Discounting Task   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Money Delay Discounting Task
Measure Description Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the "X-axis" is "days", "Y-axis" is "Money value", the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting).
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   18 
Mean Change From Baseline to Week 16 in Money Delay Discounting Task 
[Units: Unitless]
Mean (Standard Deviation)
 0.001  (0.285) 

No statistical analysis provided for Mean Change From Baseline to Week 16 in Money Delay Discounting Task



17.  Secondary:   Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item
Measure Description The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. 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, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. It took 10 to 15 minutes to complete the BIS-11. The BIS-11 was administered at the following visits: Baseline and Week 16/ET.
Time Frame Baseline and Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Measured Values
   Brexpiprazole 
Participants Analyzed   29 
Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item 
[Units: Units on a scale]
Mean (Standard Deviation)
 -4.8  (11.3) 


Statistical Analysis 1 for Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item
Groups [1] Brexpiprazole
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.0306
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis at Week 16
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events

Time Frame Adverse events were reported from the signing of the informed consent until the 30-day (+2) follow-up visit.
Additional Description No text entered.

Reporting Groups
  Description
Brexpiprazole Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.

Serious Adverse Events
    Brexpiprazole
Total, Serious Adverse Events   
# participants affected / at risk   0/49 (0.00%) 




  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
phone: 800 562-3974



Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02013622     History of Changes
Other Study ID Numbers: 331-13-006
First Submitted: December 6, 2013
First Posted: December 17, 2013
Results First Submitted: September 4, 2015
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016