ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Enrollment 49

Recruitment Details 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 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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Participants received oral brexpiprazole tablets of 1 milligram per day (mg/day) to 4 mg/day, once daily (QD) for 16 Weeks.
Period Title: Overall Study
Started 49
Completed 25
Not Completed 24
Reason Not Completed
Lost to Follow-up             10
Adverse Event             3
Met Withdrawal Criteria             3
Withdrawal by Subject             6
Protocol Deviation             1
Lack of Efficacy             1
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
26.1  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
18
  36.7%
Male
31
  63.3%
1.Primary Outcome
Title Mean Change From Baseline to Week 16 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 and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 49
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-10.2  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments 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.
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 (MMRM) method with model terms: baseline, visit, and baseline by visit interaction.
2.Secondary Outcome
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
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 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 49
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.0  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16
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 MMRM method with model terms: baseline, visit, and baseline by visit interaction.
3.Secondary Outcome
Title Mean Change From Baseline to Week 16 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 and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 49
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.6  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16
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 MMRM method with model terms: baseline, visit, and baseline by visit interaction.
4.Secondary Outcome
Title Mean Clinical Global Impression-Improvement (CGI-I) Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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)
5.Secondary Outcome
Title CGI-I Response Rate
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 39.6
Week 8 35.4
Week 12 41.7
Week 16 41.7
6.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 49
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.6  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method with model terms: baseline, visit, and baseline by visit interaction.
7.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 49
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
13.1  (3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method with model terms: baseline, visit, and baseline by visit interaction.
8.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 49
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.8  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0177
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method with model terms: baseline, visit, and baseline by visit interaction.
9.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Effectiveness 20.00  (4.09)
Side effects 10.25  (2.98)
Convenience 11.83  (2.92)
Global satisfaction 20.67  (4.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in TSQM-14 effectiveness
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 MMRM method with model terms: baseline, visit, and baseline by visit interaction.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in TSQM-14 side effects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method with model terms: baseline, visit, and baseline by visit interaction.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in TSQM-14 convenience
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method with model terms: baseline, visit, and baseline by visit interaction.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in TSQM-14 global satisfaction
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 MMRM method with model terms: baseline, visit, and baseline by visit interaction.
10.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: failures
p-inhibition failures (go cues) 0.045  (0.326)
p-inhibition failures (no-go cues) 0.066  (0.352)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (go cues)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5133
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (no-go cues)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3774
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: milliseconds
Mean reaction time (go cues) -2.05  (68.51)
Mean reaction time (no-go cues) -18.77  (90.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in Go/No-go task mean reaction time (go cues)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8897
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in Go/No-go task mean reaction time (no-go cues)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3401
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: unitless
0.008520  (0.056857)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in DDT
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4265
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: unitless
Delay Discounting Task k value -103.167142  (414.497480)
Probability Discounting Task h value 2.866008  (168.230663)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in DPDT for Delay Discounting Task k value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2923
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in DPDT for Probability Discounting Task h value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9416
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: Number of Impulsive Choices
8.9  (26.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in DRT
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1815
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Food Delay Discounting Task
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: unitless
0.037  (0.356)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in AUC for food
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6648
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16 in AUC for money
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9812
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Money Delay Discounting Task
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: unitless
0.001  (0.285)
17.Secondary Outcome
Title Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-4.8  (11.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0306
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse events were reported from the signing of the informed consent until the 30-day (+2) follow-up visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
All-Cause Mortality
Brexpiprazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brexpiprazole
Affected / at Risk (%)
Total   0/49 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brexpiprazole
Affected / at Risk (%)
Total   14/49 (28.57%) 
Gastrointestinal disorders   
Nausea * 1  3/49 (6.12%) 
Investigations   
Weight increased * 1  3/49 (6.12%) 
Nervous system disorders   
Sedation * 1  3/49 (6.12%) 
Somnolence * 1  4/49 (8.16%) 
Psychiatric disorders   
Insomnia * 1  7/49 (14.29%) 
*
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
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