Trial Outcomes & Findings for A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia (NCT NCT01451164)
NCT ID: NCT01451164
Last Updated: 2019-10-03
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
PHASE2/PHASE3
Target enrollment
459 participants
Primary outcome timeframe
Baseline, Weeks 1, 2, 3, 4, 5, and 6
Results posted on
2019-10-03
Participant Flow
Participant milestones
| Measure |
Brexpiprazole 1mg
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2mg
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4mg
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
115
|
115
|
113
|
116
|
|
Overall Study
COMPLETED
|
72
|
81
|
68
|
70
|
|
Overall Study
NOT COMPLETED
|
43
|
34
|
45
|
46
|
Reasons for withdrawal
| Measure |
Brexpiprazole 1mg
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2mg
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4mg
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
19
|
12
|
18
|
21
|
|
Overall Study
Withdrawal Criteria
|
1
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
14
|
11
|
16
|
17
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
7
|
9
|
9
|
7
|
Baseline Characteristics
A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Brexpiprazole 1mg
n=115 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2mg
n=115 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4mg
n=113 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=116 Participants
Placebo tablet once daily for 6 weeks.
|
Total
n=459 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
115 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
459 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
44.3 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
241 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
218 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
115 participants
n=5 Participants
|
115 participants
n=7 Participants
|
113 participants
n=5 Participants
|
116 participants
n=4 Participants
|
459 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score 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 1mg
n=112 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2mg
n=113 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4mg
n=109 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=113 Participants
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Week1
|
-2.68 units on a scale
Standard Error 1.04
|
-4.59 units on a scale
Standard Error 1.03
|
-3.42 units on a scale
Standard Error 1.05
|
-3.09 units on a scale
Standard Error 1.03
|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Week2
|
-5.07 units on a scale
Standard Error 1.36
|
-7.93 units on a scale
Standard Error 1.33
|
-6.80 units on a scale
Standard Error 1.36
|
-4.54 units on a scale
Standard Error 1.34
|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Week3
|
-6.92 units on a scale
Standard Error 1.60
|
-11.00 units on a scale
Standard Error 1.55
|
-9.42 units on a scale
Standard Error 1.59
|
-6.00 units on a scale
Standard Error 1.58
|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Week4
|
-8.40 units on a scale
Standard Error 1.81
|
-12.35 units on a scale
Standard Error 1.74
|
-11.21 units on a scale
Standard Error 1.80
|
-5.67 units on a scale
Standard Error 1.80
|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Week5
|
-8.13 units on a scale
Standard Error 2.02
|
-13.97 units on a scale
Standard Error 1.93
|
-11.09 units on a scale
Standard Error 2.01
|
-6.62 units on a scale
Standard Error 2.03
|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Week6
|
-8.26 units on a scale
Standard Error 2.10
|
-14.95 units on a scale
Standard Error 2.00
|
-11.49 units on a scale
Standard Error 2.10
|
-7.63 units on a scale
Standard Error 2.11
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score 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, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).
Outcome measures
| Measure |
Brexpiprazole 1mg
n=112 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2mg
n=113 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4mg
n=109 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=113 Participants
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week5
|
-2.19 units on a scale
Standard Error 0.62
|
-4.05 units on a scale
Standard Error 0.60
|
-2.89 units on a scale
Standard Error 0.62
|
-3.26 units on a scale
Standard Error 0.63
|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week1
|
-0.96 units on a scale
Standard Error 0.36
|
-1.31 units on a scale
Standard Error 0.36
|
-0.70 units on a scale
Standard Error 0.36
|
-1.09 units on a scale
Standard Error 0.35
|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week2
|
-1.72 units on a scale
Standard Error 0.45
|
-2.31 units on a scale
Standard Error 0.44
|
-1.61 units on a scale
Standard Error 0.45
|
-2.25 units on a scale
Standard Error 0.44
|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week3
|
-2.07 units on a scale
Standard Error 0.52
|
-3.21 units on a scale
Standard Error 0.51
|
-2.71 units on a scale
Standard Error 0.52
|
-2.57 units on a scale
Standard Error 0.52
|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week4
|
-2.39 units on a scale
Standard Error 0.57
|
-3.69 units on a scale
Standard Error 0.54
|
-3.09 units on a scale
Standard Error 0.56
|
-2.90 units on a scale
Standard Error 0.56
|
|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Week6
|
-2.22 units on a scale
Standard Error 0.64
|
-4.32 units on a scale
Standard Error 0.61
|
-3.15 units on a scale
Standard Error 0.64
|
-3.69 units on a scale
Standard Error 0.64
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: EEfficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score 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 social 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 1mg
n=112 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2mg
n=113 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4mg
n=109 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=113 Participants
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week1
|
-0.54 units on a scale
Standard Error 0.27
|
-0.83 units on a scale
Standard Error 0.27
|
-0.71 units on a scale
Standard Error 0.27
|
-0.59 units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week2
|
-1.08 units on a scale
Standard Error 0.37
|
-1.46 units on a scale
Standard Error 0.36
|
-1.76 units on a scale
Standard Error 0.36
|
-0.72 units on a scale
Standard Error 0.36
|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week3
|
-1.64 units on a scale
Standard Error 0.41
|
-2.41 units on a scale
Standard Error 0.39
|
-2.27 units on a scale
Standard Error 0.40
|
-1.14 units on a scale
Standard Error 0.40
|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week4
|
-2.36 units on a scale
Standard Error 0.46
|
-2.90 units on a scale
Standard Error 0.44
|
-2.94 units on a scale
Standard Error 0.46
|
-0.81 units on a scale
Standard Error 0.46
|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week5
|
-2.31 units on a scale
Standard Error 0.52
|
-3.24 units on a scale
Standard Error 0.50
|
-3.19 units on a scale
Standard Error 0.52
|
-0.85 units on a scale
Standard Error 0.52
|
|
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Week6
|
-2.34 units on a scale
Standard Error 0.55
|
-3.48 units on a scale
Standard Error 0.52
|
-3.24 units on a scale
Standard Error 0.55
|
-1.20 units on a scale
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.
Severity of illness for each participant was rated using the CGI-S, which was the 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 1mg
n=112 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2mg
n=113 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4mg
n=109 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=113 Participants
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)
Week1
|
-0.13 units on a scale
Standard Error 0.06
|
-0.18 units on a scale
Standard Error 0.06
|
-0.09 units on a scale
Standard Error 0.06
|
-0.15 units on a scale
Standard Error 0.06
|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)
Week2
|
-0.26 units on a scale
Standard Error 0.08
|
-0.36 units on a scale
Standard Error 0.08
|
-0.34 units on a scale
Standard Error 0.08
|
-0.25 units on a scale
Standard Error 0.08
|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)
Week3
|
-0.38 units on a scale
Standard Error 0.09
|
-0.52 units on a scale
Standard Error 0.09
|
-0.50 units on a scale
Standard Error 0.09
|
-0.36 units on a scale
Standard Error 0.09
|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)
Week4
|
-0.48 units on a scale
Standard Error 0.09
|
-0.62 units on a scale
Standard Error 0.09
|
-0.50 units on a scale
Standard Error 0.09
|
-0.40 units on a scale
Standard Error 0.09
|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)
Week5
|
-0.45 units on a scale
Standard Error 0.11
|
-0.81 units on a scale
Standard Error 0.10
|
-0.56 units on a scale
Standard Error 0.10
|
-0.52 units on a scale
Standard Error 0.11
|
|
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)
Week6
|
-0.52 units on a scale
Standard Error 0.11
|
-0.85 units on a scale
Standard Error 0.11
|
-0.62 units on a scale
Standard Error 0.11
|
-0.57 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, and 6Population: Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score 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 1mg
n=112 Participants
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2mg
n=113 Participants
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4mg
n=109 Participants
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=113 Participants
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
Week6
|
3.90 units on a scale
Standard Deviation 1.32
|
3.49 units on a scale
Standard Deviation 1.30
|
3.78 units on a scale
Standard Deviation 1.33
|
3.83 units on a scale
Standard Deviation 1.49
|
|
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
Week1
|
3.87 units on a scale
Standard Deviation 0.92
|
3.84 units on a scale
Standard Deviation 0.96
|
4.01 units on a scale
Standard Deviation 0.93
|
3.92 units on a scale
Standard Deviation 1.04
|
|
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
Week2
|
3.87 units on a scale
Standard Deviation 1.10
|
3.68 units on a scale
Standard Deviation 1.02
|
3.79 units on a scale
Standard Deviation 1.13
|
3.88 units on a scale
Standard Deviation 1.26
|
|
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
Week3
|
3.89 units on a scale
Standard Deviation 1.20
|
3.53 units on a scale
Standard Deviation 1.04
|
3.77 units on a scale
Standard Deviation 1.20
|
3.92 units on a scale
Standard Deviation 1.36
|
|
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
Week4
|
3.83 units on a scale
Standard Deviation 1.23
|
3.51 units on a scale
Standard Deviation 1.16
|
3.81 units on a scale
Standard Deviation 1.23
|
3.90 units on a scale
Standard Deviation 1.36
|
|
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
Week5
|
3.92 units on a scale
Standard Deviation 1.27
|
3.42 units on a scale
Standard Deviation 1.23
|
3.76 units on a scale
Standard Deviation 1.30
|
3.86 units on a scale
Standard Deviation 1.48
|
Adverse Events
Brexpiprazole 1mg
Serious events: 8 serious events
Other events: 49 other events
Deaths: 0 deaths
Brexpiprazole 2mg
Serious events: 5 serious events
Other events: 46 other events
Deaths: 0 deaths
Brexpiprazole 4mg
Serious events: 5 serious events
Other events: 49 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brexpiprazole 1mg
n=115 participants at risk
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2mg
n=114 participants at risk
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4mg
n=113 participants at risk
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=116 participants at risk
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.87%
1/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.88%
1/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.87%
1/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Investigations
Electroencephalogram abnormal
|
0.87%
1/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Psychiatric disorders
Schizophrenia
|
6.1%
7/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
4.4%
5/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
3.5%
4/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
4.3%
5/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.87%
1/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.88%
1/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
Other adverse events
| Measure |
Brexpiprazole 1mg
n=115 participants at risk
Brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2mg
n=114 participants at risk
Brexpiprazole 2 mg tablet once daily for 6 weeks.
|
Brexpiprazole 4mg
n=113 participants at risk
Brexpiprazole 4 mg tablet once daily for 6 weeks.
|
Placebo
n=116 participants at risk
Placebo tablet once daily for 6 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.0%
8/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
7.0%
8/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
6.2%
7/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
7.8%
9/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
7/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
4.4%
5/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
7.1%
8/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
3.4%
4/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
4/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
2.6%
3/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
5.3%
6/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
1.7%
2/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
4/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
5.3%
6/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
2.7%
3/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
1.7%
2/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Gastrointestinal disorders
Dental caries
|
5.2%
6/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.00%
0/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
3.5%
4/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
0.86%
1/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
10.4%
12/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
7.0%
8/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
8.8%
10/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
9.5%
11/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Investigations
Blood prolactin increased
|
0.87%
1/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
2.6%
3/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
6.2%
7/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
2.6%
3/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Nervous system disorders
Headache
|
7.0%
8/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
7.9%
9/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
2.7%
3/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
4.3%
5/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Nervous system disorders
Akathisia
|
1.7%
2/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
3.5%
4/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
5.3%
6/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
6.9%
8/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
|
Psychiatric disorders
Schizophrenia
|
17.4%
20/115 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
11.4%
13/114 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
20.4%
23/113 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
24.1%
28/116 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place