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Trial record 1 of 1 for:    NCT01649557
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Multicenter, Open-label, Safety and Tolerability Study (STEP 210)

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ClinicalTrials.gov Identifier: NCT01649557
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : October 29, 2015
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: OPC-34712
Enrollment 244
Recruitment Details The protocol was initially approved as a 6-week trial and later extended to a 52-week trial (Amendment 2). The trial enrolled 244 participants at 73 sites in 12 countries. Of the 244 participants, 28 were included in the 52-week enrollment population.
Pre-assignment Details Trial consisted of a screening visit, treatment phase and safety follow-up at 30 (± 2) days after the last dose of medication. Eligible participants for the trial were those who completed protocol NCT00905307 and who in the investigators judgment would benefit from the treatment.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Period Title: Overall Study
Started 179 41 24
6-week Enrollers 159 35 22
52-week Enrollers 20 6 2
Completed 135 27 15
Not Completed 44 14 9
Reason Not Completed
Lost to Follow-up             5             0             3
Adverse Event             7             5             1
Met withdrawal criteria             4             0             0
Physician Decision             8             2             1
Withdrawal by Subject             15             5             4
Protocol deviation             0             2             0
Lack of Efficacy             5             0             0
Arm/Group Title Prior Brexiprazole Prior Placebo Prior Apripiprazole Total
Hide Arm/Group Description The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. Total of all reporting groups
Overall Number of Baseline Participants 179 41 24 244
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 179 participants 41 participants 24 participants 244 participants
39.1  (10.1) 41.4  (11.2) 41.2  (12) 39.7  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 179 participants 41 participants 24 participants 244 participants
Female
69
  38.5%
17
  41.5%
5
  20.8%
91
  37.3%
Male
110
  61.5%
24
  58.5%
19
  79.2%
153
  62.7%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) During First 6 Weeks.
Hide Description AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Time Frame From Baseline up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety dataset comprised of those participants who received at least one dose of open-label brexpiprazole and were enrolled in the 6-week study.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description:
The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Overall Number of Participants Analyzed 178 41 23
Measure Type: Number
Unit of Measure: Participants
Participants with AEs 79 19 7
Participants with TEAEs 78 19 7
Participants with serious TEAEs 4 6 1
Participants with severe TEAEs 2 3 2
2.Primary Outcome
Title Number of Participants With AEs in 52-Week Enrollers.
Hide Description AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Time Frame From Baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Those participants who received at least one dose of open-label brexpiprazole and who were enrolled in the 52-week study.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description:
The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Overall Number of Participants Analyzed 20 6 2
Measure Type: Number
Unit of Measure: Participants
Participants with AEs 15 4 2
Participants with TEAEs 15 4 2
Participants with serious TEAEs 0 0 0
Participants with severe TEAEs 0 1 0
3.Secondary Outcome
Title Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.
Hide Description The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.
Time Frame Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description:
The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Overall Number of Participants Analyzed 178 41 23
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 4 (N= 169, 36, 22) 0.11  (5.86) -1.25  (3.97) -1.50  (4.97)
Week 1 (N= 167, 40, 23) -2.03  (5.49) -1.53  (7.95) -1.91  (6.22)
Week 2 (N= 165, 40, 21) -2.95  (8.80) -3.43  (10.68) -1.86  (6.04)
Week 4 (N=148, 34, 18) -4.65  (8.59) -4.71  (12.85) -5.39  (6.30)
Week 6 (N= 138, 31, 15) -7.51  (8.82) -7.87  (10.26) -7.47  (7.22)
Week 8 (N=20, 6, 2) -8.80  (8.69) -5.17  (7.55) -10.00  (1.41)
Week 14 (N=20, 6, 2) -9.85  (8.09) 6.83  (28.29) -3.50  (12.02)
Week 20 (N= 20, 5, 2) -10.20  (9.12) -4.60  (10.71) -6.50  (10.61)
Week 26 (N= 19, 5, 2) -12.89  (9.34) -5.80  (11.56) -10.50  (7.78)
Week 32 (N= 18, 5, 2) -14.67  (10.94) -3.00  (16.90) -16.00  (0.00)
Week 38 (N= 17, 3, 2) -13.24  (10.97) -4.67  (10.21) -13.00  (0.00)
Week 44 (N= 17, 2, 2) -16.00  (10.28) -4.50  (12.02) -11.50  (2.12)
Week 52 (N= 16, 2, 2) -15.00  (10.06) -5.50  (13.44) -11.00  (7.07)
Last visit (N= 176, 41, 23) -5.99  (11.25) -2.32  (18.97) -5.96  (8.27)
4.Secondary Outcome
Title Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.
Hide Description The severity of illness for each participant were rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices include: 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, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description:
The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Overall Number of Participants Analyzed 178 41 23
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 4 (N= 169, 36, 22) 0.02  (0.51) -0.03  (0.29) 0.05  (0.38)
Week 1 (N= 167, 40, 23) -0.08  (0.47) -0.05  (0.60) -0.04  (0.37)
Week 2 (N= 164, 40, 21) -0.12  (0.63) -0.18  (0.71) 0.00  (0.32)
Week 4 (N= 148, 34, 18) -0.25  (0.64) -0.24  (0.82) -0.22  (0.43)
Week 6 (N= 139, 31, 15) -0.40  (0.66) -0.35  (0.80) -0.33  (0.49)
Week 8 (N= 20, 6, 2) -0.20  (0.77) 0.17  (0.41) 0.00  (0.00)
Week 14 (N= 20, 6, 2) -0.40  (0.68) 0.83  (1.60) 0.50  (0.71)
Week 20 (N= 20, 5, 2) -0.55  (0.76) 0.20  (0.45) 0.00  (0.00)
Week 26 (N= 19, 5, 2) -0.63  (0.90) 0.00  (0.71) 0.00  (0.00)
Week 32 (N= 18, 5, 2) -0.78  (0.81) 0.20  (1.10) -0.50  (0.71)
Week 38 (N= 17, 3, 2) -0.71  (0.85) 0.00  (0.00) -0.50  (0.71)
Week 44 (N= 17, 2, 2) -0.82  (0.81) 0.00  (0.00) -0.50  (0.71)
Week 52 (N= 16, 2, 2) -0.88  (0.81) 0.00  (0.00) -0.50  (0.71)
Last visit (N= 176, 41, 23) -0.33  (0.83) -0.15  (1.20) -0.30  (0.56)
5.Secondary Outcome
Title Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.
Hide Description The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Time Frame Baseline, Week 1, 2, 6, 26, 52 and Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description:
The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Overall Number of Participants Analyzed 178 41 23
Median (Full Range)
Unit of Measure: Units on a scale
Week 1 (N= 5, 1, 1)
-2.00
(-10.00 to 2.00)
-21.00
(-21.00 to -21.00)
-5.00
(-5.00 to -5.00)
Week 2 (N= 163, 40, 21)
1.00
(-23.00 to 20.00)
1.50
(-13.00 to 30.00)
0.00
(-6.00 to 10.00)
Week 6 (N= 139, 31, 15)
5.00
(-47.00 to 35.00)
6.00
(-10.00 to 40.00)
1.00
(-8.00 to 16.00)
Week 26 (N= 19, 5, 2)
6.00
(0.00 to 20.00)
12.00
(-5.00 to 14.00)
2.50
(0.00 to 5.00)
Week 52 (N= 16, 2, 2)
13.00
(0.00 to 30.00)
13.00
(12.00 to 14.00)
0.50
(0.00 to 1.00)
Last visit (N= 171, 41, 22)
4.00
(-47.00 to 35.00)
5.00
(-50.00 to 40.00)
1.00
(-8.00 to 16.00)
6.Secondary Outcome
Title Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.
Hide Description The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Time Frame Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description:
The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Overall Number of Participants Analyzed 178 41 23
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 4 (N= 169, 36, 22) 3.70  (0.87) 3.56  (0.88) 3.23  (1.15)
Week 1 (N= 167, 40, 23) 3.51  (0.89) 3.73  (0.93) 3.13  (1.14)
Week 2 (N= 164, 40, 21) 3.41  (1.10) 3.45  (1.28) 3.38  (1.28)
Week 4 (N= 148, 34, 18) 3.14  (1.04) 3.26  (1.21) 2.94  (1.21)
Week 6 (N= 139, 31, 15) 2.86  (0.99) 3.03  (1.28) 2.60  (1.18)
Week 8 (N= 20, 6, 2) 2.80  (0.95) 3.50  (1.22) 3.00  (1.41)
Week 14 (N= 20, 6, 2) 2.75  (0.85) 3.83  (1.60) 4.50  (0.71)
Week 20 (N= 20, 5, 2) 2.70  (1.03) 3.20  (1.30) 4.00  (0.00)
Week 26 (N= 19, 5, 2) 2.74  (0.93) 3.00  (1.41) 4.00  (0.00)
Week 32 (N= 18, 5, 2) 2.56  (0.78) 3.20  (1.79) 3.00  (1.41)
Week 38 (N= 17, 3, 2) 2.53  (0.87) 2.67  (1.15) 3.00  (1.41)
Week 44 (N= 17, 2, 2) 2.35  (0.79) 3.00  (1.41) 3.00  (1.41)
Week 52 (N= 16, 2, 2) 2.31  (0.79) 3.00  (1.41) 3.00  (1.41)
Last visit (N= 176, 41, 23) 3.04  (1.14) 3.32  (1.52) 2.83  (1.19)
7.Secondary Outcome
Title Change From Baseline in PANSS Positive Subscale Score.
Hide Description The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
Time Frame Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description:
The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Overall Number of Participants Analyzed 178 41 23
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 4 (N= 169, 36, 22) -0.04  (2.06) -0.50  (1.36) 0.09  (2.24)
Week 1 (N= 167, 40, 23) -0.66  (1.91) -0.25  (2.72) -0.78  (2.76)
Week 2 (N= 165, 40, 21) -1.09  (2.92) -0.70  (3.75) -0.05  (2.84)
Week 4 (N= 148, 34, 18) -1.53  (2.96) -1.06  (3.95) -1.11  (2.08)
Week 6 (N= 138, 31, 15) -2.36  (3.21) -2.03  (3.06) -1.87  (2.39)
Week 8 (N= 20, 6, 2) -2.10  (3.02) -1.67  (2.34) -2.50  (2.12)
Week 14 (20, 6, 2) -2.80  (2.65) 2.17  (9.04) 1.00  (4.24)
Week 20 (20, 5, 2) -2.60  (3.49) -1.80  (2.39) 0.00  (4.24)
Week 26 (N= 19, 5, 2) -3.42  (2.99) -2.60  (2.61) -3.00  (1.41)
Week 32 (N= 18, 5, 2) -3.83  (3.54) -1.00  (4.85) -5.00  (1.41)
Week 38 (N= 17, 3, 2) -3.71  (4.10) -2.67  (2.52) -3.00  (0.00)
Week 44 (N= 17, 2, 2) -4.24  (3.53) -1.50  (2.12) -4.00  (1.41)
Week 52 (N= 16, 2, 2) -3.63  (3.74) -1.50  (2.12) -4.50  (3.54)
Last visit (N= 176, 41, 23) -1.74  (3.86) -0.22  (6.04) -1.43  (2.87)
8.Secondary Outcome
Title Change From Baseline in PANSS Negative Subscale Score.
Hide Description The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
Time Frame Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description:
The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Overall Number of Participants Analyzed 178 41 23
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 4 (N= 169, 36, 22) -0.01  (1.99) -0.25  (1.00) -0.86  (2.12)
Week 1 (N= 167, 40, 23) -0.47  (2.15) -0.40  (2.58) -0.87  (2.44)
Week 2 (N= 165, 40, 21) -0.68  (2.61) -0.83  (2.32) -1.19  (2.52)
Week 4 (N= 148, 34, 18) -1.03  (2.99) -1.35  (3.02) -1.94  (2.48)
Week 6 (N= 138, 31, 15) -1.70  (3.04) -1.97  (2.70) -2.40  (2.61)
Week 8 (N= 20, 6, 2) -2.55  (2.68) -1.00  (2.00) -1.00  (1.41)
Week 14 (N= 20, 6, 2) -2.85  (3.15) 1.17  (7.05) -1.50  (2.12)
Week 20 (N= 20, 5, 2) -3.00  (3.04) -0.60  (1.14) -2.00  (2.83)
Week 26 (N= 19, 5, 2) -3.74  (3.43) -1.20  (1.48) -2.50  (2.12)
Week 32 (N= 18, 5, 2) -4.00  (4.41) -1.00  (1.87) -2.50  (3.54)
Week 38 (N= 17, 3, 2) -3.94  (3.93) -0.67  (2.08) -2.50  (3.54)
Week 44 (N= 17, 2, 2) -4.18  (3.61) -1.00  (2.83) -2.50  (3.54)
Week 52 (N= 16, 2, 2) -4.00  (3.58) -1.00  (2.83) -2.00  (1.41)
Last visit (N= 176, 41, 23) -1.53  (3.28) -1.10  (3.85) -2.09  (2.59)
9.Secondary Outcome
Title Percentage of Participants With a Positive Response Rate.
Hide Description Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.
Time Frame Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description:
The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Overall Number of Participants Analyzed 179 41 24
Measure Type: Number
Unit of Measure: Percentage of participants
33.5 36.6 45.8
10.Secondary Outcome
Title Percentage of Participants Who Discontinued Due to Lack of Efficacy.
Hide Description Discontinuation rate for the participants discontinued due to lack of efficacy were examined.
Time Frame Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description:
The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
Overall Number of Participants Analyzed 179 41 24
Measure Type: Number
Unit of Measure: Percentage of participants.
2.8 0.0 0.0
Time Frame AEs were recorded from Screening (ICF was signed) to Follow-up 30 (± 2) days, up to 52 weeks.
Adverse Event Reporting Description The safety dataset comprised of those participants who received at least one dose of open-label brexpiprazole.
 
Arm/Group Title Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Hide Arm/Group Description The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
All-Cause Mortality
Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/178 (2.25%)      6/41 (14.63%)      1/23 (4.35%)    
Infections and infestations       
Bronchitis * 1  0/178 (0.00%)  0 1/41 (2.44%)  1 0/23 (0.00%)  0
Influenza * 1  0/178 (0.00%)  0 1/41 (2.44%)  1 0/23 (0.00%)  0
Nervous system disorders       
Convulsion * 1  0/178 (0.00%)  0 1/41 (2.44%)  1 0/23 (0.00%)  0
Psychiatric disorders       
Psychotic disorder * 1  2/178 (1.12%)  2 1/41 (2.44%)  1 1/23 (4.35%)  1
Schizophrenia * 1  2/178 (1.12%)  2 3/41 (7.32%)  3 0/23 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V11.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prior Brexpiprazole Prior Placebo Prior Aripiprazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/178 (17.42%)      10/41 (24.39%)      4/23 (17.39%)    
Nervous system disorders       
Extrapyramidal disorder * 1  2/178 (1.12%)  1/41 (2.44%)  2/23 (8.70%) 
Headache * 1  6/178 (3.37%)  5/41 (12.20%)  0/23 (0.00%) 
Tremor * 1  9/178 (5.06%)  1/41 (2.44%)  0/23 (0.00%) 
Psychiatric disorders       
Insomnia * 1  10/178 (5.62%)  3/41 (7.32%)  0/23 (0.00%) 
Anxiety * 1  5/178 (2.81%)  0/41 (0.00%)  2/23 (8.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01649557    
Other Study ID Numbers: 331-08-210
First Submitted: July 20, 2012
First Posted: July 25, 2012
Results First Submitted: August 4, 2015
Results First Posted: October 29, 2015
Last Update Posted: October 29, 2015