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Trial record 35 of 64 for:    brexpiprazole

Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment

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ClinicalTrials.gov Identifier: NCT02013609
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 MDD
Intervention Drug: Brexpiprazole
Enrollment 48
Recruitment Details This trial was conducted in 48 participants at 24 sites in the United States; 15 of the 24 trial sites enrolled participants.
Pre-assignment Details The trial consisted of a 2 to 21-day screening phase, a 12-week (84-day) treatment phase, and a 30-day (+ 2) follow-up phase.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Participants were administered oral brexpiprazole tablet of 0.5 milligram per day (mg/day) for the first week with titration up to 3 mg/day once daily (QD) in addition to their constant-dose antidepressant therapy (ADT) for 12 weeks.
Period Title: Overall Study
Started 47 [1]
Completed 29
Not Completed 18
Reason Not Completed
Withdrawal by Subject             9
Lost to Follow-up             3
Adverse Event             3
Met Withdrawal Criteria             3
[1]
One participant out of 48 participants enrolled had discontinued before receiving study medication.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
26.6  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
32
  68.1%
Male
15
  31.9%
1.Primary Outcome
Title Mean Change From Baseline to Week 12 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). Detailed instructions for administration of this structured interview was provided in the SIGMA. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60.
Time Frame Baseline and Week 12
Hide 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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-18.1  (1.4)
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 MADRS total score at Week 12 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 measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction
2.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Total 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 12
Hide 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.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.0  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12.
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 with model terms: Baseline, visit, and Baseline by visit interaction
3.Secondary Outcome
Title Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 12
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 Weeks 1, 2, 3, 4, 5, 6, 8, 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment; the last-observation-carried-forward (LOCF) dataset included data recorded at a scheduled visit or, data was carried forward from the previous scheduled visit, if no observation was recorded at that visit
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 46) 3.5  (0.8)
Week 2 (N= 47) 3.0  (0.8)
Week 3 (N= 47) 2.8  (1.0)
Week 4 (N= 47) 2.7  (1.0)
Week 6 (N= 47) 2.6  (1.3)
Week 8 (N= 47) 2.5  (1.2)
Week 10 (N= 47) 2.3  (1.2)
Week 12 (N= 47) 2.2  (1.3)
4.Secondary Outcome
Title Number of Participants With CGI-I Response
Hide Description The CGI-I response rate was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).
Time Frame Weeks 1, 2, 3, 4, 6, 8 ,10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment; the last-observation-carried-forward (LOCF) dataset included data recorded at a scheduled visit or, data was carried forward from the previous scheduled visit, if no observation was recorded at that visit
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
Week 1 (N= 46) 4
Week 2 (N= 47) 12
Week 3 (N= 47) 17
Week 4 (N= 47) 24
Week 6 (N= 47) 27
Week 8 (N= 47) 29
Week 10 (N= 47) 28
Week 12 (N= 47) 30
5.Secondary Outcome
Title Percentage of Participants With MADRS Response
Hide Description MADRS response rate was defined as ≥ 50% reduction in respective total scores from Baseline to Week 12.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percentage of particpants
53.2
6.Secondary Outcome
Title Percentage of Participants With MADRS Remission
Hide Description MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Baseline to Week 12.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percentage of participants
42.6
7.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Hamilton Depression Rating Scale (HAM-D17) Total Score
Hide Description The HAM-D17 was utilized as an assessment of a participants level of depression and was administered utilizing the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D). Detailed instructions for administration of this structured interview were provided in the SIGH-D. HAM-D17 is a 17-item questionnaire with a total score of 0 to 52 with higher scores indicating more depressive symptoms.
Time Frame Baseline and Week 12
Hide 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. Mixed model repeated measures was performed on the OC dataset.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-14.9  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12.
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 with model terms: Baseline, visit, and Baseline by visit interaction.
8.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) 3-item Total/Summed Score
Hide Description The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Time Frame Baseline and Week 12
Hide 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. Mixed model repeated measures was performed on the OC dataset.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.74  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12.
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 with model terms: Baseline, visit, and Baseline by visit interaction
9.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) Single Item Sub-scores
Hide Description The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment.
Time Frame Baseline and Week 12
Hide 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. Mixed model repeated measures was performed on the OC dataset.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Work/ school -3.5  (0.5)
Social life -3.9  (0.6)
Family life/ home responsibilities -3.7  (5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12 of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is the same for each of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities
Method Mixed Models Analysis
Comments MMRM with model terms: Baseline, visit, and Baseline by visit interaction
10.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Social Adaptation Self-evaluation Scale (SASS) Total Score
Hide Description The SASS was a self-rated instrument to assess the social motivation and behavior in participants with depression. It contained 21 items covering the different aspects of social interactions, global social attitude, and self-perception. The SASS total score will be un-evaluable if less than 16 of the 20 items (for item number 1 and item number 2, participant is to answer either one of these) are recorded. If 16 to 19 of the 20 items are recorded, the SASS total score will be the mean of the recorded items multiplied by 20 and then rounded to the first decimal place.Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range of 0 to 60 (higher scores, indicating worse outcome).
Time Frame Baseline and Week 12
Hide 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. Mixed model repeated measures was performed on the OC dataset.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
9.7  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12.
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 with model terms: Baseline, visit, and Baseline by visit interaction
11.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score
Hide Description The MGH-CPFQ was a participant-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The MGH-CPFQ consisted of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranged from 7 to 42.
Time Frame Baseline and Week 12
Hide 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. Mixed model repeated measures was performed on the OC dataset.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-8.1  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12
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 with model terms: Baseline, visit, and Baseline by visit interaction
12.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Kellner Symptom Questionnaire (KSQ) Total Score
Hide Description KSQ is a subject-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility and somatization. The questionnaire contains 92 items of which 68 items indicate symptoms and 24 items are antonyms of some of the symptoms that indicate well-being. The maximum score for each symptom subscale is 17, the well-being subscales 6 and for the total scale scores 23.The total subscale scores will be unevaluable if less than 19 of the 23 items are recorded. If 19 to 22 of the 23 items are recorded, the total subscale score is the mean of the recorded items multiplied by 23 and then rounded to the first decimal place. The total score will be unevaluable if less than 76 of the 92 items are recorded. If 76 to 91 of the 92 items and no less than 19 of the 23 items of each subscale are recorded, the total score will be the mean of the recorded items multiplied by 92 and then rounded to the first decimal place. A higher score indicates more distress than a lower score.
Time Frame Baseline and Week 12
Hide 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. Mixed model repeated measures was performed on the OC dataset.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-30.5  (3.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12
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 with model terms: Baseline, visit, and Baseline by visit interaction
13.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Go/No-Go Task (P-inhibition Failure)
Hide Description Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. 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 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: failures
P-inhibition failures (Go cues) 0.052  (0.299)
P-inhibition failures (No-Go cues) 0.052  (0.295)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12 for p-inhibition failures (Go cues)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3439
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for change from Baseline using t-test.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12 for p-inhibition failures (No-Go cues)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3385
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for change from Baseline using t-test.
14.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Go/No-Go Task (Mean Reaction Time)
Hide Description Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: milliseconds
Mean reaction time (Go cues) -17.35  (73.34)
Mean reaction time (No-Go cues) -12.99  (70.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12 for mean reaction time (Go cues)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2052
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for change from Baseline using t-test.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12 for mean reaction time (No-Go cues)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3224
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for change from Baseline using t-test.
15.Secondary Outcome
Title Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) k Value
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 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: unitless
0.009531  (0.055516)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3169
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for change from Baseline using t-test.
16.Secondary Outcome
Title Mean Change From Baseline to Week 12 in the 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 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: Number of Impulsive Choices
3.6  (15.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3352
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Delay and Probability Discounting Task (DPDT)
Hide Description The experiential discounting task (EDT) was a subject-completed computerized task designed to measure delay discounting, 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 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 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: unitless
Delay Discounting Task k value 21.315241  (116.798133)
Delay Discounting Task h value 10.350419  (60.212518)
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Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12 for delay discounting task k value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3517
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 12 for delay discounting task h value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3799
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Mean Change From Baseline in Food Delay Discounting Task (DDT)
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 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: unitless
0.3487  (1.4158)
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Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12 (AUC for food)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2610
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 12 (AUC for money)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8138
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Mean Change From Baseline 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 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: unitless
-0.0095  (0.1859)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12 (AUC for money)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8138
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
20.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Barratt Impulsiveness Scale 11-Item (BIS-11) Total Score
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.
Time Frame Baseline and Week 12
Hide 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. Mixed model repeated measures was performed on the OC dataset.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Overall Number of Participants Analyzed 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-7.1  (1.5)
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Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 12.
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 with model terms: Baseline, visit, and Baseline by visit interaction
Time Frame Adverse events were reported from the signing of the informed consent until the last dose of brexpiprazole with a safety follow-up of 30 (+2) days.
Adverse Event Reporting Description One participant out of 48 participants enrolled had discontinued before receiving study medication.
 
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
All-Cause Mortality
Brexpiprazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brexpiprazole
Affected / at Risk (%)
Total   0/47 (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   39/47 (82.98%) 
Gastrointestinal disorders   
Abdominal Discomfort * 1  3/47 (6.38%) 
Diarrhoea * 1  4/47 (8.51%) 
Nausea * 1  5/47 (10.64%) 
Investigations   
Weight increased * 1  8/47 (17.02%) 
Metabolism and nutrition disorders   
Increased appetite * 1  3/47 (6.38%) 
Nervous system disorders   
Akathisia * 1  3/47 (6.38%) 
Dizziness * 1  4/47 (8.51%) 
Headache * 1  10/47 (21.28%) 
Sedation * 1  4/47 (8.51%) 
Somnolence * 1  8/47 (17.02%) 
Psychiatric disorders   
Anxiety * 1  6/47 (12.77%) 
Depression * 1  3/47 (6.38%) 
Insomnia * 1  5/47 (10.64%) 
Libido decreased * 1  3/47 (6.38%) 
*
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: NCT02013609     History of Changes
Other Study ID Numbers: 331-13-003
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