Trial Outcomes & Findings for Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia (NCT NCT01393613)
NCT ID: NCT01393613
Last Updated: 2015-11-26
Results Overview
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
674 participants
Primary outcome timeframe
Baseline, Weeks 1, 2, 3, 4, 5, and 6
Results posted on
2015-11-26
Participant Flow
This trial was conducted in 674 participants from 68 trial sites in 8 countries.
Adults with schizophrenia as defined by Diagnostic and Statistical Manual of Mental Health Disorders 4th Edition Text Revision criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) for schizophrenia and psychotic disorders studies were included.
Participant milestones
| Measure |
Brexpiprazole 1 mg
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
120
|
186
|
184
|
184
|
|
Overall Study
COMPLETED
|
81
|
129
|
130
|
118
|
|
Overall Study
NOT COMPLETED
|
39
|
57
|
54
|
66
|
Reasons for withdrawal
| Measure |
Brexpiprazole 1 mg
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
11
|
13
|
22
|
|
Overall Study
Participant Met Withdrawal Criteria
|
0
|
0
|
2
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
15
|
25
|
23
|
21
|
|
Overall Study
Protocol Deviation
|
2
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
9
|
20
|
16
|
21
|
Baseline Characteristics
Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia
Baseline characteristics by cohort
| Measure |
Brexpiprazole 1 mg
n=120 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
n=186 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=184 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=184 Participants
Placebo tablet once daily for 6 weeks.
|
Total
n=674 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.1 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
36.9 Years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
38.6 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
39.3 Years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
38.4 Years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
251 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
423 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 1
|
-4.35 Units on a scale
Standard Error 0.68
|
-5.58 Units on a scale
Standard Error 0.68
|
-3.48 Units on a scale
Standard Error 0.68
|
-3.32 Units on a scale
Standard Error 0.83
|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 2
|
-8.70 Units on a scale
Standard Error 0.88
|
-8.42 Units on a scale
Standard Error 0.88
|
-6.61 Units on a scale
Standard Error 0.89
|
-7.61 Units on a scale
Standard Error 1.09
|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 3
|
-10.69 Units on a scale
Standard Error 1.06
|
-12.63 Units on a scale
Standard Error 1.05
|
-8.95 Units on a scale
Standard Error 1.06
|
-11.56 Units on a scale
Standard Error 1.30
|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 4
|
-13.12 Units on a scale
Standard Error 1.21
|
-15.55 Units on a scale
Standard Error 1.19
|
-11.10 Units on a scale
Standard Error 1.22
|
-13.97 Units on a scale
Standard Error 1.49
|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 5
|
-14.11 Units on a scale
Standard Error 1.38
|
-17.26 Units on a scale
Standard Error 1.37
|
-11.89 Units on a scale
Standard Error 1.40
|
-14.47 Units on a scale
Standard Error 1.71
|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 6
|
-16.61 Units on a scale
Standard Error 1.49
|
-20.00 Units on a scale
Standard Error 1.48
|
-13.53 Units on a scale
Standard Error 1.52
|
-16.90 Units on a scale
Standard Error 1.86
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
Severity of illness for each participant was rated using the CGI-S, which was the key secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=180 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=183 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=181 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=120 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.
Week 1
|
-0.16 Units on a scale
Standard Error 0.04
|
-0.22 Units on a scale
Standard Error 0.04
|
-0.12 Units on a scale
Standard Error 0.04
|
-0.11 Units on a scale
Standard Error 0.05
|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.
Week 2
|
-0.40 Units on a scale
Standard Error 0.05
|
-0.40 Units on a scale
Standard Error 0.05
|
-0.36 Units on a scale
Standard Error 0.05
|
-0.31 Units on a scale
Standard Error 0.06
|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.
Week 3
|
-0.60 Units on a scale
Standard Error 0.06
|
-0.69 Units on a scale
Standard Error 0.06
|
-0.44 Units on a scale
Standard Error 0.06
|
-0.63 Units on a scale
Standard Error 0.07
|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.
Week 4
|
-0.72 Units on a scale
Standard Error 0.07
|
-0.85 Units on a scale
Standard Error 0.07
|
-0.58 Units on a scale
Standard Error 0.07
|
-0.67 Units on a scale
Standard Error 0.09
|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.
Week 5
|
-0.79 Units on a scale
Standard Error 0.08
|
-1.02 Units on a scale
Standard Error 0.08
|
-0.68 Units on a scale
Standard Error 0.08
|
-0.81 Units on a scale
Standard Error 0.10
|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.
Week 6
|
-0.99 Units on a scale
Standard Error 0.09
|
-1.19 Units on a scale
Standard Error 0.08
|
-0.81 Units on a scale
Standard Error 0.09
|
-0.91 Units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Week 3 and Week 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
PSP is a validated clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (e.g. work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=170 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=174 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=163 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=105 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score.
Week 3
|
6.85 Units on a scale
Standard Error 0.73
|
7.12 Units on a scale
Standard Error 0.71
|
5.80 Units on a scale
Standard Error 0.73
|
6.97 Units on a scale
Standard Error 0.90
|
|
Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score.
Week 6
|
10.52 Units on a scale
Standard Error 0.95
|
13.11 Units on a scale
Standard Error 0.94
|
8.52 Units on a scale
Standard Error 0.97
|
11.73 Units on a scale
Standard Error 1.19
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). The analysis of secondary endpoints was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Although only the comparison of brexpiprazole 4 mg/day vs placebo met the gatekeeping threshold in the primary analysis, statistical testing for the other doses was reported for information.
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week 1
|
-1.43 Units on a scale
Standard Error 0.23
|
-1.80 Units on a scale
Standard Error 0.23
|
-1.25 Units on a scale
Standard Error 0.23
|
-0.93 Units on a scale
Standard Error 0.28
|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week 2
|
-2.76 Units on a scale
Standard Error 0.32
|
-2.93 Units on a scale
Standard Error 0.32
|
-2.56 Units on a scale
Standard Error 0.32
|
-2.54 Units on a scale
Standard Error 0.39
|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week 3
|
-3.56 Units on a scale
Standard Error 0.37
|
-4.43 Units on a scale
Standard Error 0.37
|
-3.34 Units on a scale
Standard Error 0.37
|
-3.94 Units on a scale
Standard Error 0.46
|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week 4
|
-4.35 Units on a scale
Standard Error 0.42
|
-5.16 Units on a scale
Standard Error 0.41
|
-3.93 Units on a scale
Standard Error 0.42
|
-4.83 Units on a scale
Standard Error 0.52
|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week 5
|
-4.68 Units on a scale
Standard Error 0.47
|
-6.04 Units on a scale
Standard Error 0.46
|
-4.33 Units on a scale
Standard Error 0.47
|
-4.80 Units on a scale
Standard Error 0.58
|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week 6
|
-5.42 Units on a scale
Standard Error 0.50
|
-6.65 Units on a scale
Standard Error 0.50
|
-4.95 Units on a scale
Standard Error 0.51
|
-5.63 Units on a scale
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week 1
|
-0.52 Units on a scale
Standard Error 0.20
|
-0.88 Units on a scale
Standard Error 0.20
|
-0.40 Units on a scale
Standard Error 0.20
|
-0.31 Units on a scale
Standard Error 0.25
|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week 2
|
-1.31 Units on a scale
Standard Error 0.23
|
-1.42 Units on a scale
Standard Error 0.23
|
-0.79 Units on a scale
Standard Error 0.24
|
-1.27 Units on a scale
Standard Error 0.29
|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week 3
|
-1.80 Units on a scale
Standard Error 0.28
|
-2.15 Units on a scale
Standard Error 0.28
|
-1.18 Units on a scale
Standard Error 0.28
|
-2.06 Units on a scale
Standard Error 0.35
|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week 4
|
-2.09 Units on a scale
Standard Error 0.32
|
-2.69 Units on a scale
Standard Error 0.32
|
-1.67 Units on a scale
Standard Error 0.33
|
-2.56 Units on a scale
Standard Error 0.40
|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week 5
|
-2.50 Units on a scale
Standard Error 0.35
|
-2.82 Units on a scale
Standard Error 0.35
|
-1.74 Units on a scale
Standard Error 0.36
|
-2.71 Units on a scale
Standard Error 0.44
|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week 6
|
-2.91 Units on a scale
Standard Error 0.38
|
-3.36 Units on a scale
Standard Error 0.38
|
-2.14 Units on a scale
Standard Error 0.39
|
-2.92 Units on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Week 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. 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.
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=180 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=183 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=181 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=120 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
|
3.17 Units on a scale
Standard Deviation 1.34
|
2.95 Units on a scale
Standard Deviation 1.33
|
3.48 Units on a scale
Standard Deviation 1.46
|
3.20 Units on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Week 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of 1 or 2.
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Response at Week 6.
|
38.5 percentage of participants
|
49.7 percentage of participants
|
31.7 percentage of participants
|
43.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
Participants discontinued for lack of efficacy during the trial were reported here.
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Discontinuation Rate for Lack of Efficacy at Week 6.
|
11.2 percentage of participants
|
8.84 percentage of participants
|
11.7 percentage of participants
|
7.69 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.
Week 1
|
-0.46 Units on a scale
Standard Error 0.21
|
-1.01 Units on a scale
Standard Error 0.21
|
-0.48 Units on a scale
Standard Error 0.21
|
-0.35 Units on a scale
Standard Error 0.25
|
|
Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.
Week 2
|
-1.31 Units on a scale
Standard Error 0.26
|
-1.21 Units on a scale
Standard Error 0.26
|
-0.62 Units on a scale
Standard Error 0.26
|
-0.76 Units on a scale
Standard Error 0.32
|
|
Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.
Week 3
|
-1.31 Units on a scale
Standard Error 0.28
|
-1.81 Units on a scale
Standard Error 0.28
|
-0.82 Units on a scale
Standard Error 0.29
|
-1.21 Units on a scale
Standard Error 0.35
|
|
Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.
Week 4
|
-1.52 Units on a scale
Standard Error 0.29
|
-2.12 Units on a scale
Standard Error 0.29
|
-1.12 Units on a scale
Standard Error 0.30
|
-1.58 Units on a scale
Standard Error 0.37
|
|
Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.
Week 5
|
-1.48 Units on a scale
Standard Error 0.34
|
-2.27 Units on a scale
Standard Error 0.34
|
-0.97 Units on a scale
Standard Error 0.35
|
-1.16 Units on a scale
Standard Error 0.42
|
|
Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.
Week 6
|
-1.90 Units on a scale
Standard Error 0.33
|
-2.86 Units on a scale
Standard Error 0.33
|
-1.47 Units on a scale
Standard Error 0.34
|
-1.94 Units on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.
Week 1
|
-1.77 Units on a scale
Standard Error 0.23
|
-1.75 Units on a scale
Standard Error 0.24
|
-1.30 Units on a scale
Standard Error 0.24
|
-1.44 Units on a scale
Standard Error 0.29
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.
Week 2
|
-3.10 Units on a scale
Standard Error 0.32
|
-3.03 Units on a scale
Standard Error 0.32
|
-3.03 Units on a scale
Standard Error 0.32
|
-2.97 Units on a scale
Standard Error 0.39
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.
Week 3
|
-4.09 Units on a scale
Standard Error 0.38
|
-4.39 Units on a scale
Standard Error 0.37
|
-3.78 Units on a scale
Standard Error 0.38
|
-4.48 Units on a scale
Standard Error 0.47
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.
Week 4
|
-4.93 Units on a scale
Standard Error 0.43
|
-5.48 Units on a scale
Standard Error 0.43
|
-4.67 Units on a scale
Standard Error 0.44
|
-5.42 Units on a scale
Standard Error 0.53
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.
Week 5
|
-5.35 Units on a scale
Standard Error 0.47
|
-6.41 Units on a scale
Standard Error 0.46
|
-5.47 Units on a scale
Standard Error 0.47
|
-5.86 Units on a scale
Standard Error 0.58
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.
Week 6
|
-6.26 Units on a scale
Standard Error 0.53
|
-7.05 Units on a scale
Standard Error 0.53
|
-5.91 Units on a scale
Standard Error 0.54
|
-6.56 Units on a scale
Standard Error 0.66
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.
Week 1
|
-0.85 Units on a scale
Standard Error 0.22
|
-1.12 Units on a scale
Standard Error 0.23
|
-0.66 Units on a scale
Standard Error 0.22
|
-0.70 Units on a scale
Standard Error 0.28
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.
Week 2
|
-1.86 Units on a scale
Standard Error 0.26
|
-1.72 Units on a scale
Standard Error 0.26
|
-1.38 Units on a scale
Standard Error 0.26
|
-1.71 Units on a scale
Standard Error 0.32
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.
Week 3
|
-2.30 Units on a scale
Standard Error 0.30
|
-2.64 Units on a scale
Standard Error 0.30
|
-1.83 Units on a scale
Standard Error 0.30
|
-2.55 Units on a scale
Standard Error 0.37
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.
Week 4
|
-2.63 Units on a scale
Standard Error 0.34
|
-3.17 Units on a scale
Standard Error 0.34
|
-2.16 Units on a scale
Standard Error 0.35
|
-3.21 Units on a scale
Standard Error 0.43
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.
Week 5
|
-3.13 Units on a scale
Standard Error 0.38
|
-3.21 Units on a scale
Standard Error 0.37
|
-2.24 Units on a scale
Standard Error 0.38
|
-3.35 Units on a scale
Standard Error 0.47
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.
Week 6
|
-3.53 Units on a scale
Standard Error 0.39
|
-3.84 Units on a scale
Standard Error 0.39
|
-2.55 Units on a scale
Standard Error 0.40
|
-3.55 Units on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.
Week 1
|
-0.46 Units on a scale
Standard Error 0.19
|
-0.78 Units on a scale
Standard Error 0.19
|
-0.42 Units on a scale
Standard Error 0.19
|
-0.40 Units on a scale
Standard Error 0.23
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.
Week 2
|
-1.15 Units on a scale
Standard Error 0.22
|
-1.37 Units on a scale
Standard Error 0.22
|
-0.71 Units on a scale
Standard Error 0.23
|
-1.42 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.
Week 3
|
-1.71 Units on a scale
Standard Error 0.25
|
-2.32 Units on a scale
Standard Error 0.25
|
-1.35 Units on a scale
Standard Error 0.26
|
-2.35 Units on a scale
Standard Error 0.31
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.
Week 4
|
-2.27 Units on a scale
Standard Error 0.29
|
-2.83 Units on a scale
Standard Error 0.29
|
-1.77 Units on a scale
Standard Error 0.30
|
-2.56 Units on a scale
Standard Error 0.36
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.
Week 5
|
-2.55 Units on a scale
Standard Error 0.33
|
-3.42 Units on a scale
Standard Error 0.32
|
-2.01 Units on a scale
Standard Error 0.33
|
-2.95 Units on a scale
Standard Error 0.41
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.
Week 6
|
-2.94 Units on a scale
Standard Error 0.35
|
-3.98 Units on a scale
Standard Error 0.34
|
-2.59 Units on a scale
Standard Error 0.35
|
-3.46 Units on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.
Week 1
|
-0.10 Units on a scale
Standard Error 0.18
|
-0.63 Units on a scale
Standard Error 0.18
|
-0.21 Units on a scale
Standard Error 0.18
|
0.03 Units on a scale
Standard Error 0.22
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.
Week 2
|
-0.65 Units on a scale
Standard Error 0.23
|
-0.68 Units on a scale
Standard Error 0.23
|
-0.13 Units on a scale
Standard Error 0.23
|
-0.15 Units on a scale
Standard Error 0.28
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.
Week 3
|
-0.61 Units on a scale
Standard Error 0.24
|
-1.16 Units on a scale
Standard Error 0.24
|
-0.19 Units on a scale
Standard Error 0.24
|
-0.46 Units on a scale
Standard Error 0.30
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.
Week 4
|
-0.74 Units on a scale
Standard Error 0.26
|
-1.31 Units on a scale
Standard Error 0.25
|
-0.39 Units on a scale
Standard Error 0.26
|
-0.74 Units on a scale
Standard Error 0.32
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.
Week 5
|
-0.60 Units on a scale
Standard Error 0.29
|
-1.50 Units on a scale
Standard Error 0.29
|
-0.22 Units on a scale
Standard Error 0.30
|
-0.34 Units on a scale
Standard Error 0.36
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.
Week 6
|
-0.81 Units on a scale
Standard Error 0.29
|
-1.89 Units on a scale
Standard Error 0.29
|
-0.64 Units on a scale
Standard Error 0.30
|
-0.90 Units on a scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).
Outcome measures
| Measure |
Brexpiprazole 2 mg
n=179 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=181 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Placebo
n=180 Participants
Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
|
Brexpiprazole 1 mg
n=117 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.
Week 1
|
-1.10 Units on a scale
Standard Error 0.18
|
-1.26 Units on a scale
Standard Error 0.18
|
-0.96 Units on a scale
Standard Error 0.18
|
-1.18 Units on a scale
Standard Error 0.22
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.
Week 2
|
-1.91 Units on a scale
Standard Error 0.22
|
-1.60 Units on a scale
Standard Error 0.22
|
-1.47 Units on a scale
Standard Error 0.22
|
-1.86 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.
Week 3
|
-2.10 Units on a scale
Standard Error 0.23
|
-2.24 Units on a scale
Standard Error 0.23
|
-1.97 Units on a scale
Standard Error 0.23
|
-2.43 Units on a scale
Standard Error 0.28
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.
Week 4
|
-2.70 Units on a scale
Standard Error 0.23
|
-2.93 Units on a scale
Standard Error 0.23
|
-2.60 Units on a scale
Standard Error 0.23
|
-2.85 Units on a scale
Standard Error 0.29
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.
Week 5
|
-2.87 Units on a scale
Standard Error 0.25
|
-3.09 Units on a scale
Standard Error 0.25
|
-2.69 Units on a scale
Standard Error 0.26
|
-2.93 Units on a scale
Standard Error 0.31
|
|
Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.
Week 6
|
-3.62 Units on a scale
Standard Error 0.24
|
-3.78 Units on a scale
Standard Error 0.24
|
-2.93 Units on a scale
Standard Error 0.24
|
-3.57 Units on a scale
Standard Error 0.30
|
Adverse Events
Brexpiprazole 1 mg
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Brexpiprazole 2 mg
Serious events: 4 serious events
Other events: 65 other events
Deaths: 0 deaths
Brexpiprazole 4 mg
Serious events: 4 serious events
Other events: 66 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brexpiprazole 1 mg
n=120 participants at risk
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
n=186 participants at risk
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=184 participants at risk
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=184 participants at risk
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
General disorders
Irritability
|
0.00%
0/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.00%
0/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.00%
0/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.54%
1/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.00%
0/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.00%
0/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.54%
1/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
|
Psychiatric disorders
Aggression
|
0.83%
1/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.00%
0/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.00%
0/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.00%
0/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
|
Psychiatric disorders
Psychotic disorder
|
0.83%
1/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
1.1%
2/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.54%
1/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.54%
1/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
|
Psychiatric disorders
Schizophrenia
|
0.83%
1/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
1.1%
2/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
1.6%
3/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
4.3%
8/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.00%
0/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.54%
1/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
0.00%
0/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
Other adverse events
| Measure |
Brexpiprazole 1 mg
n=120 participants at risk
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
n=186 participants at risk
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4 mg
n=184 participants at risk
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=184 participants at risk
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
7/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
3.8%
7/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
3.3%
6/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
3.3%
6/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
|
Nervous system disorders
Akathisia
|
4.2%
5/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
4.8%
9/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
6.5%
12/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
7.1%
13/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
|
Nervous system disorders
Headache
|
7.5%
9/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
10.8%
20/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
10.3%
19/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
14.7%
27/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
|
Psychiatric disorders
Agitation
|
8.3%
10/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
8.6%
16/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
7.1%
13/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
7.1%
13/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
|
Psychiatric disorders
Insomnia
|
12.5%
15/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
13.4%
25/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
15.2%
28/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
14.7%
27/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
|
Psychiatric disorders
Schizophrenia
|
3.3%
4/120 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
3.2%
6/186 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
3.8%
7/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
5.4%
10/184 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 (+2) days after the last dose of study medication.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place