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Trial record 7 of 64 for:    brexpiprazole

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

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ClinicalTrials.gov Identifier: NCT02194933
Recruitment Status : Completed
First Posted : July 21, 2014
Results First Posted : September 11, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia With Impulsivity
Intervention Drug: Brexpiprazole
Enrollment 38
Recruitment Details The study was conducted in the United States (US). 38 participants with schizophrenia with impulsivity were enrolled (signed informed consent) and randomized (1:1): 19 participants to brexpiprazole 2mg and 4mg treatment each; received at least 1 dose of Investigational medicinal product (IMP) for 6-week treatment phase in a double-blind design.
Pre-assignment Details Participants had pretreatment screening phase from 2 to 21 days to assess eligibility criteria, complete screening assessments & to wash out from prior antipsychotic drugs & any other prohibited concomitant drugs; participants were followed for safety by clinic visits/telephone (after first 3 to 4 days of antipsychotic washout & weekly as needed).
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET) Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Period Title: Overall Study
Started 19 19
Completed 16 10
Not Completed 3 9
Reason Not Completed
Lost to Follow-up             1             2
Participant met withdrawal criteria             1             3
Withdrawal by Subject             0             2
Lack of Efficacy             1             2
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg Total
Hide Arm/Group Description Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET) Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET. Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
19
 100.0%
38
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
45.2  (10.0) 47.4  (11.1) 46.3  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
3
  15.8%
3
  15.8%
6
  15.8%
Male
16
  84.2%
16
  84.2%
32
  84.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
Race   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Caucasian (White) 6 7 13
Black or African or American 8 12 20
Asian 2 0 2
Others 3 0 3
[1]
Measure Description: Different races were involved in this study
Ethinicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Hispanic/Latino 4 3 7
Not Hispanic/Latino 15 16 31
1.Primary Outcome
Title Change From Baseline Brain Activation in the Ventrolateral Prefrontal Cortex (VLPFC) Based on Change From Baseline to Week 6 in fMRI Blood Oxygen-level Dependent (BOLD) Activation Score in the Right VLPFC During Performance of the Go/No-go Task
Hide Description To evaluate the effect of brexpiprazole on brain regions activated by impulsive behavior (specifically, activation of the right VLPFC). Assessed by fMRI measurements taken when participants perform tasks designed to assess impulsivity. The tasks to be performed in the scanner included the Go/No-go. Participants were asked to press a button as fast as they could to Stimulus A (eg, neutral face) that appeared on the screen (Go trials) & to NOT press a button to Stimulus B (eg, happy face) that appeared on the screen (No-go trials). The Go trials were presented at a higher frequency (eg, 75% of the time) than the No-go trials to build up a pre-potent response/response bias. Scores were not bounded by a minimum or maximum range, higher fMRI BOLD activation scores indicate increased brain blood flow, which reflects brain activity.
Time Frame At baseline (Day 0), and week 6 (Day 42) of the treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a valid baseline and a Week 6 fMRI scan assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
At Week 0 Number Analyzed 14 participants 13 participants
0.06450  (0.02815) 0.06609  (0.02875)
At Week 6 Number Analyzed 13 participants 10 participants
0.04949  (0.02878) 0.04326  (0.03128)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg, Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3992
Comments Test for Baseline vs. Week 6
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline Brain Activation in the VLPFC Based on Change From Baseline to Week 6 in fMRI BOLD Activation Score in the Right VLPFC During Performance of the SSRT Task
Hide Description To evaluate the effect of brexpiprazole on brain regions activated by impulsive behavior (specifically, activation of the right VLPFC). Assessed by fMRI measurements taken when participants performed impulsivity assessment tasks. A white circle was shown for 500ms, followed by a left (<)/right (>) arrow. When an arrow was presented, participants responded as fast as possible with their index/middle finger. A titration procedure with 4 staircases started with stop signal delay (SSD) values of 100, 150, 200 & 250ms to determine participant’s SSRT. The tasks included 3 runs with 166 repetition times (TRs), TR=2s; 5 minutes, 32 seconds/run; 96 go trials, 32 stop trials/ run. The total task duration was 16 minutes & 36 seconds. Scores were not bounded by a minimum or maximum range, higher fMRI BOLD activation scores indicate increased brain blood flow, which reflects brain activity.
Time Frame At baseline (Day 0), and week 6 (Day 42) of the treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a valid baseline and a valid Week 3 or Week 6 fMRI scan assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
At Week 0 Number Analyzed 15 participants 14 participants
0.05200  (0.02993) 0.09485  (0.03428)
At Week 6 Number Analyzed 11 participants 10 participants
-0.00140  (0.03048) 0.002815  (0.03541)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg, Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0053
Comments Test for Baseline vs. Week 6
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Week 3 in fMRI BOLD Activation Score in the Right VLPFC, Scanned by fMRI During Performance of Tasks Associated With Impulsivity (SSRT Task, Go/No-go Task)
Hide Description

Go/No-go: Participants were to press button fast to Stimulus A (neutral face) (Go trials) & to NOT press button to Stimulus B (happy face) (No-go trials). Task comprised 4 runs of 3 minutes & 8 seconds each. Each run included 36 target (Go) & 13 non target (No-go) stimuli. The stimuli were presented for 500ms with 2 to 14.5 inter-stimulus interval fixation cross in between. Target stimuli were pseudo-randomized across runs so that each participant was presented with 2 Happy Go & 2 Neutral Go conditions.

SSRT: White circle was shown for 500ms, followed by left (<)/right (>) arrow. When an arrow was presented, participants were to respond fast with their index/middle finger. A titration procedure with 4 staircases that started with stop signal delay (SSD) values of 100, 150, 200 & 250ms determined participant’s SSRT.

Scores were not bounded by a minimum or maximum range, higher fMRI BOLD activation scores indicate increased brain blood flow, which reflects brain activity.

Time Frame At baseline (Day 0), and week 3 (Day 21) of the treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a valid baseline and a valid Week 3 fMRI scan assessment
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
GNG; Week 0 Number Analyzed 14 participants 13 participants
0.06347  (0.02801) 0.06553  (0.02869)
GNG; Week 3 Number Analyzed 14 participants 13 participants
0.08523  (0.02801) 0.04973  (0.02869)
SSRT; Week 0 Number Analyzed 15 participants 11 participants
0.05376  (0.02903) 0.09550  (0.03346)
SSRT; Week 3 Number Analyzed 14 participants 11 participants
0.06398  (0.02979) 0.02410  (0.03346)
4.Secondary Outcome
Title Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11)
Hide Description A participant-rated scale was used 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) and the scores were used to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance and cognitive instability impulsiveness) and 3 second-order factors ( motor impulsiveness, nonplanning impulsiveness and attentional impulsiveness). The total score ranged from 30 to 120 with higher scores indicating impulsive personality traits, and took 10 to 15 minutes to complete the BIS-11.
Time Frame At baseline (Day 0), and Week 6 (Day 42) of the treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consisted of all participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment. Change from baseline data were presented for participant count of 16, 12 for 2mg and 4mg arms, respectively.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 16 12
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.6  (1.8) 1.0  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1559
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6201
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Week 3 in BIS-11
Hide Description A participant-rated scale was used 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) and the scores were used to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance and cognitive instability impulsiveness) and 3 second-order factors ( motor impulsiveness, nonplanning impulsiveness and attentional impulsiveness). The total score ranged from 30 to 120 with higher scores indicating impulsive personality traits, and took 10 to 15 minutes to complete the BIS-11.
Time Frame At baseline (Day 0), and Week 3 (Day 21) of the treatment.
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 postbaseline efficacy assessment. All participants who had a valid baseline and a valid Week 3 or Week 6 fMRI scan assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.4  (1.7) -2.3  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1642
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1873
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Week 6 in Go/No-go Task Behavior
Hide Description Brexpiprazole reduced impulsivity was measured by a change in false alarm rate on the Go/No-go task (a lower false alarm rate was suggestive of better inhibition). Participants were instructed to press a button as fast as they could to Stimulus A (eg, neutral face) that appeared on the screen (Go trials) and to NOT press a button to Stimulus B (eg, happy face) that appeared on the screen (No-go trials). The stimuli were presented randomly. The value calculated was the rate of incorrect response for each condition (Go and No-go).
Time Frame At baseline (Day 0), week 6 (Day 42) of the treatment phase
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Millisecond
At Week 0 Number Analyzed 14 participants 13 participants
0.11  (0.08) 0.09  (0.06)
At Week 6 Number Analyzed 13 participants 10 participants
0.08  (0.09) 0.12  (0.17)
7.Secondary Outcome
Title Change From Baseline to Week 3 in Go/No-go Task Behavior
Hide Description Brexpiprazole reduced impulsivity was measured by a change in false alarm rate on the Go/No-go task (a lower false alarm rate was suggestive of better inhibition). Participants were instructed to press a button as fast as they could to Stimulus A (eg, neutral face) that appeared on the screen (Go trials) and to NOT press a button to Stimulus B (eg, happy face) that appeared on the screen (No-go trials). The stimuli were presented randomly. The value calculated was the rate of incorrect response for each condition (Go and No-go).
Time Frame At baseline (Day 0), and week 3 (Day 21) of the treatment phase
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Millisecond
Week 0 Number Analyzed 14 participants 13 participants
0.11  (0.08) 0.09  (0.06)
Week 3 Number Analyzed 14 participants 13 participants
0.10  (0.13) 0.15  (0.14)
8.Secondary Outcome
Title Change From Baseline to Week 6 in Monetary Choice Questionnaire (MCQ) Score
Hide Description To measure “delay discounting” 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. 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 consisted of 27 choices between immediate and delayed rewards. The participants chose repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (ex: ‘‘Would you prefer $27 today or $50 in 21 days?”). The answers provided an estimate of the participant's discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicated impulsivity. It took 5 to10 minutes to complete the MCQ
Time Frame During trial visits from Day 0 to Week 6 (Day 42).
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.019762  (0.015213) 0.023685  (0.017103)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2061
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1778
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to Week 3 in MCQ Score
Hide Description To measure “delay discounting” 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. 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 consisted of 27 choices between immediate and delayed rewards. The participants chose repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (ex: ‘‘Would you prefer $27 today or $50 in 21 days?”). The answers provided an estimate of the participant's discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicated impulsivity.
Time Frame During trial visits from Day 0 to Week 3 (Day 21).
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.012073  (0.014558) 0.014520  (0.014891)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4138
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3375
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to Week 6 in Stop Signal Reaction Time Task (SSRT) Task Behavior
Hide Description Brexpiprazole reduced impulsivity was measured by a change in Stop Signal Reaction Time (SSRT) on the SSRT task (a lower SSRT was suggestive of better inhibition). A white circle was shown for 500ms, followed by a left (<)/right (>) arrow. When an arrow was presented, participants responded as fast as possible with their index/middle finger. A titration procedure with 4 staircases started with stop signal delay (SSD) values of 100, 150, 200 & 250ms to determine participant's SSRT. The tasks included 3 runs with 166 repetition times (TRs), TR=2s; 5 minutes, 32 seconds/run; 96 go trials, 32 stop trials/ run. The total task duration was 16 minutes & 36 seconds. During scanning, the SSD was dynamically adjusted to yield a 50% successful inhibition rate, so that SSRT could be estimated for each participant. This resulted in approximately equal proportions of stop trials with & without a response
Time Frame At baseline (Day 0), and Week 6 (Day 42).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a valid baseline and a valid Week 6 fMRI scan assessment
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Millisecond
At Week 0 Number Analyzed 12 participants 10 participants
357.63  (61.51) 323.25  (56.59)
At Week 6 Number Analyzed 11 participants 7 participants
299.68  (67.77) 302.57  (34.68)
11.Secondary Outcome
Title Change From Baseline to Week 3 in SSRT Task Behavior
Hide Description Brexpiprazole reduced impulsivity was measured by a change in Stop Signal Reaction Time (SSRT) on the SSRT task (a lower SSRT was suggestive of better inhibition). A white circle was shown for 500ms, followed by a left (<)/right (>) arrow. When an arrow was presented, participants responded as fast as possible with their index/middle finger. A titration procedure with 4 staircases started with stop signal delay (SSD) values of 100, 150, 200 & 250ms to determine participant’s SSRT. The tasks included 3 runs with 166 repetition times (TRs), TR=2s; 5 minutes, 32 seconds/run; 96 go trials, 32 stop trials/ run. The total task duration was 16 minutes & 36 seconds. During scanning, the SSD was dynamically adjusted to yield a 50% successful inhibition rate, so that SSRT could be estimated for each participant. This resulted in approximately equal proportions of stop trials with & without a response
Time Frame During trial visits from Day 0 to Week 3 (Day 21).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a valid baseline and a valid Week 3 fMRI scan assessment
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Median (Standard Deviation)
Unit of Measure: Millisecond
At week 0 Number Analyzed 12 participants 10 participants
357.63  (61.51) 323.25  (56.59)
At week 3 Number Analyzed 13 participants 10 participants
337.62  (76.23) 328.05  (54.62)
12.Secondary Outcome
Title Change From Baseline to Week 6 in Continuous Performance Task (CPT) Behavior
Hide Description The AX trials were “target trials” with a valid cue followed by a valid probe X. This feature was intended to encourage participants to “expect” a valid probe to follow a valid cue. A consequence of this manipulation was that participants developed a prepotency to respond with “target” responses on trials for which valid cues were presented. The cue was presented for 1000msec, the inter-stimulus interval was 2000msec, and the target was presented for 500msec with a response window of 1500msec. The ITI was 1200msec. Participants had to practice until criteria were obtained. In the AX‐CPT task, the subjects were instructed to press the “Yes” button every time there is a blue letter ‘X’ (target) following a white letter ‘A’ (cue). During this task, any letter appears on the screen randomly. The value calculated was the rate of correct response for all the reaction of target trial.
Time Frame During trial visits from Day 0 to Week 6 (Day 42).
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 postbaseline efficacy assessment
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:

Brexpiprazole 2 mg/day, once daily dose, tablet, orally

Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks

Brexpiprazole 4 mg/day, once daily dose, tablet, orally

Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks

Overall Number of Participants Analyzed 19 19
Least Squares Mean (Standard Error)
Unit of Measure: Rate of correct response
-0.70  (3.50) -0.87  (4.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8437
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8318
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline to Week 3 in CPT Behavior
Hide Description The AX trials were “target trials” with a valid cue followed by a valid probe X. This feature was intended to encourage participants to “expect” a valid probe to follow a valid cue. A consequence of this manipulation was that participants developed a prepotency to respond with “target” responses on trials for which valid cues were presented. The cue was presented for 1000msec, the inter-stimulus interval was 2000msec, and the target was presented for 500msec with a response window of 1500msec. The ITI was 1200msec. Participants had to practice until criteria were obtained. In the AX‐CPT task, the subjects were instructed to press the “Yes” button every time there is a blue letter ‘X’ (target) following a white letter ‘A’ (cue). During this task, any letter appears on the screen randomly. The value calculated was the rate of correct response for all the reaction of target trial.
Time Frame During trial visits from Day 0 to Week 3 (Day 21).
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 14 14
Least Squares Mean (Standard Error)
Unit of Measure: Rate of correct response
1.79  (4.14) -0.61  (4.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6697
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8829
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Hide Description The PANSS consisted of 3 subscales containing 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS Positive and Negative subscale scores symptom constructs consisted of positive subscale (7 positive symptom constructs), negative subscale (7 negative symptom constructs), and general psychopathology subscale (16 symptom constructs). The possible maximum PANSS total score was 210; 30 indicating no symptoms; 210 indicating extremely severe symptoms.
Time Frame During trial visits from Day 0 to Week 6 (Day 42).
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 postbaseline efficacy assessment
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 16 12
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.4  (1.9) -4.1  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2301
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0599
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline to Week 3 in PANSS Total Score
Hide Description The PANSS consisted of 3 subscales containing 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS Positive and Negative subscale scores symptom constructs consisted of positive subscale (7 positive symptom constructs), negative subscale (7 negative symptom constructs), and general psychopathology subscale (16 symptom constructs). The possible maximum PANSS total score was 210; 30 indicating no symptoms; 210 indicating extremely severe symptoms.
Time Frame During trial visits from Day 0 to Week 3 (Day 21).
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 postbaseline efficacy assessment
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.0  (1.4) -2.3  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1595
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1211
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS Positive Subscale Score
Hide Description PANSS consisted of positive subscales with 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item was scored using a scale of 1 to 7 (a higher score indicated increased severity). The maximum subscale score was 49; 7 indicated no symptoms; 49 indicated extreme severity.
Time Frame During trial visits from Day 0 to Week 6 (Day 42).
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 16 12
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.4  (0.9) -1.3  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1322
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2113
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline to Week 3 in PANSS Positive Subscale Score
Hide Description PANSS consisted of positive subscales with 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item was scored using a scale of 1 to 7 (a higher score indicated increased severity). The maximum subscale score was 49; 7 indicated no symptoms; 49 indicated extreme severity.
Time Frame During trial visits from Day 0 to Week 3 (Day 21).
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.2  (0.6) -1.3  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0578
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0588
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS Negative Subscale Score
Hide Description PANSS consisted of negative subscale with 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item was scored using a scale of 1 to 7 (a higher score indicated increased severity). The maximum subscale score was 49; 7 indicated no symptoms; 49 indicated extreme severity.
Time Frame During trial visits from Day 0 to Week 6 (Day 42).
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 postbaseline efficacy assessment
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 16 12
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.9  (0.6) 0.2  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1666
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7670
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline to Week 3 in PANSS Negative Subscale Score
Hide Description PANSS consisted of negative subscale with 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item was scored using a scale of 1 to 7 (a higher score indicated increased severity). The maximum subscale score was 49; 7 indicated no symptoms; 49 indicated extreme severity.
Time Frame During trial visits from Day 0 to Week 3 (Day 21).
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.2  (0.7) 0.8  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7178
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2336
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline to Week 6 in Clinical Global Impression – Severity of Illness Scale (CGI-S) Score
Hide Description The severity of illness for each participant was assessed. The rater or investigator's 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 During trial visits from Day 0 to Week 6 (Day 42).
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 16 12
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.1  (0.1) 0.0  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6558
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9058
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline to Week 3 in CGI-S Score
Hide Description The severity of illness for each participant was assessed. The rater or investigator's 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 During trial visits from Day 0 to Week 3 (Day 21).
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.3  (0.1) -0.1  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4272
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
22.Secondary Outcome
Title Clinical Global Impression – Improvement Scale (CGI-I) Score at Week 6
Hide Description To assess whether the total improvement was entirely due to drug treatment. The rater or investigator's 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 to the participant's condition at baseline (last available measurement at the baseline/Day 0 visit before the first dose of IMP).
Time Frame During trial visits from Day 0 to Week 6 (Day 42).
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.6  (1.0) 3.9  (0.5)
23.Secondary Outcome
Title CGI-I Score at Week 3
Hide Description To assess whether the total improvement was entirely due to drug treatment. The rater or investigator's 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 to the participant's condition at baseline (last available measurement at the baseline/Day 0 visit before the first dose of IMP).
Time Frame During trial visits from Day 0 to Week 3 (Day 21).
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 postbaseline efficacy assessment.
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:
Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.7  (0.8) 3.8  (0.5)
24.Secondary Outcome
Title Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)
Hide Description A validated clinician-rated scale that measured personal and social functioning in 4 domains: socially useful activities (eg, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment was rated as absent, mild, manifest, marked, severe, or very severe and were converted to a total score on a 100-point scale: 71 to 100 - mild functional difficulty, 31 to 70 - manifest disabilities of various degrees and 1 to 30 - minimal functioning that required intense support and/or supervision.
Time Frame During trial visits from Day 0 to Week 6 (Day 42).
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 postbaseline efficacy assessment
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description:

Brexpiprazole 2 mg/day, once daily dose, tablet, orally

Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks

Brexpiprazole 4 mg/day, once daily dose, tablet, orally

Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks

Overall Number of Participants Analyzed 17 14
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.7  (1.6) -0.0  (1.7)
Time Frame Trial visits (Days 0 to 42)
Adverse Event Reporting Description An adverse event (AE) was any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug-related. Suspected adverse reaction (AR) - any AE caused by drug; in drug safety reporting, “reasonable possibility” meant to suggest a causal relationship between the drug and the AE. A serious AE (SAE) included any event that resulted in death, life-threatening, inability, hospitalization, congenital anomaly and requirement of medical/surgical intervention
 
Arm/Group Title Brexpiprazole 2 mg Brexpiprazole 4 mg
Hide Arm/Group Description

Brexpiprazole 2 mg/day, once daily dose, tablet, orally

Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks

Brexpiprazole 4 mg/day, once daily dose, tablet, orally

Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks

All-Cause Mortality
Brexpiprazole 2 mg Brexpiprazole 4 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Brexpiprazole 2 mg Brexpiprazole 4 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (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 2 mg Brexpiprazole 4 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   13/19 (68.42%)   14/19 (73.68%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  1/19 (5.26%)  1/19 (5.26%) 
Dyspepsia * 1  1/19 (5.26%)  1/19 (5.26%) 
Infections and infestations     
Nasopharyngitis * 1  2/19 (10.53%)  0/19 (0.00%) 
Investigations     
Blood creatine phosphokinase increased * 1  1/19 (5.26%)  1/19 (5.26%) 
Weight increased * 1  1/19 (5.26%)  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/19 (5.26%)  2/19 (10.53%) 
Nervous system disorders     
Akathisia * 1  1/19 (5.26%)  1/19 (5.26%) 
Extrapyramidal disorder * 1  1/19 (5.26%)  1/19 (5.26%) 
Headache * 1  3/19 (15.79%)  2/19 (10.53%) 
Somnolence * 1  1/19 (5.26%)  1/19 (5.26%) 
Psychiatric disorders     
Agitation * 1  0/19 (0.00%)  2/19 (10.53%) 
Anxiety * 1  0/19 (0.00%)  2/19 (10.53%) 
Insomnia * 1  2/19 (10.53%)  2/19 (10.53%) 
Irritability * 1  2/19 (10.53%)  0/19 (0.00%) 
Restlessness * 1  2/19 (10.53%)  0/19 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion * 1  1/19 (5.26%)  0/19 (0.00%) 
Oropharyngeal pain * 1  1/19 (5.26%)  0/19 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  1/19 (5.26%)  0/19 (0.00%) 
Hyperkeratosis * 1  1/19 (5.26%)  0/19 (0.00%) 
1
Term from vocabulary, MedDRA Preferred Ter
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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 Clinical Development
Organization: Otsuka Data Transparency Organization
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02194933     History of Changes
Other Study ID Numbers: 331-13-009
First Submitted: July 16, 2014
First Posted: July 21, 2014
Results First Submitted: May 3, 2017
Results First Posted: September 11, 2018
Last Update Posted: November 8, 2018