Trial Outcomes & Findings for A Study of Brexpiprazole in Patients With Major Depressive Disorder (NCT NCT03697603)
NCT ID: NCT03697603
Last Updated: 2024-08-09
Results Overview
The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consisted of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item was scored from 0 to 6, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 60, with higher scores indicating worse condition.The mean changes were compared between antidepressant treatments and brexpiprazole as adjunctive therapy.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
740 participants
Primary outcome timeframe
Baseline (the end of Phase A), at completion of administration (Week 6).
Results posted on
2024-08-09
Participant Flow
This trial was conducted in 740 participants from 145 trial sites in Japan.
Adults with major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and who had not responded sufficiently to antidepressants (SSRIs or SNRIs) were included.
Participant milestones
| Measure |
Brexpiprazole 1 mg
Participants received brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
Participants received brexpiprazole 1 mg tablet once daily for 1 week followed by 2 mg tablet once daily for 5 weeks.
|
Placebo
Participants received placebo tablet once daily for 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
250
|
246
|
244
|
|
Overall Study
COMPLETED
|
238
|
219
|
232
|
|
Overall Study
NOT COMPLETED
|
12
|
27
|
12
|
Reasons for withdrawal
| Measure |
Brexpiprazole 1 mg
Participants received brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
Participants received brexpiprazole 1 mg tablet once daily for 1 week followed by 2 mg tablet once daily for 5 weeks.
|
Placebo
Participants received placebo tablet once daily for 6 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
18
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
1
|
Baseline Characteristics
A Study of Brexpiprazole in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Brexpiprazole 1 mg
n=248 Participants
Participants received brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
n=245 Participants
Participants received brexpiprazole 1 mg tablet once daily for 1 week followed by 2 mg tablet once daily for 5 weeks.
|
Placebo
n=243 Participants
Participants received placebo tablet once daily for 6 weeks.
|
Total
n=736 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
|
|
Age, Categorical
Between 18 and 65 years
|
248 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
736 Participants
n=4 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
|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
323 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
413 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
248 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
736 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
248 participants
n=5 Participants
|
245 participants
n=7 Participants
|
243 participants
n=5 Participants
|
736 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (the end of Phase A), at completion of administration (Week 6).Population: FAS (Same as Baseline Analysis Population Description)
The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consisted of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item was scored from 0 to 6, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 60, with higher scores indicating worse condition.The mean changes were compared between antidepressant treatments and brexpiprazole as adjunctive therapy.
Outcome measures
| Measure |
Brexpiprazole 1 mg
n=248 Participants
Participants received brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
n=245 Participants
Participants received brexpiprazole 1 mg tablet once daily for 1 week followed by 2 mg tablet once daily for 5 weeks.
|
Placebo
n=243 Participants
Participants received placebo tablet once daily for 6 weeks.
|
|---|---|---|---|
|
Mean Changes From Baseline (Week 8 of the Antidepressant Treatment Period [Phase A]) in the MADRS Total Scores at Week 6 of the Double-blind Period (Phase B).
|
-8.5 Units on a scale
Standard Error 0.47
|
-8.2 Units on a scale
Standard Error 0.47
|
-6.7 Units on a scale
Standard Error 0.47
|
SECONDARY outcome
Timeframe: Baseline (the end of Phase A), at completion of administration (Week 6).Population: FAS (Same as Baseline Analysis Population Description)
Clinical Global Impression - Improvement (CGI-I) improvement rate: the proportion of participants who score 1 or 2 on the CGI-I scale at Week 6 of the double-blind period (Phase B). The CGI-I Scale was a clinician-rated scale which assessed the total improvement of the participant's condition compared to that at baseline. Scores range from 0 to 7:0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicated worse condition.
Outcome measures
| Measure |
Brexpiprazole 1 mg
n=248 Participants
Participants received brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
n=245 Participants
Participants received brexpiprazole 1 mg tablet once daily for 1 week followed by 2 mg tablet once daily for 5 weeks.
|
Placebo
n=243 Participants
Participants received placebo tablet once daily for 6 weeks.
|
|---|---|---|---|
|
CGI-I Improvement Rate at Week 6 of the Double-blind Period (Phase B)
|
35.1 percentage of participants
|
35.1 percentage of participants
|
29.6 percentage of participants
|
Adverse Events
Brexpiprazole 1 mg
Serious events: 3 serious events
Other events: 108 other events
Deaths: 0 deaths
Brexpiprazole 2 mg
Serious events: 3 serious events
Other events: 153 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brexpiprazole 1 mg
n=250 participants at risk
Participants received brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
n=246 participants at risk
Participants received brexpiprazole 1 mg tablet once daily for 1 week followed by 2 mg tablet once daily for 5 weeks.
|
Placebo
n=244 participants at risk
Participants received placebo tablet once daily for 6 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.41%
1/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Appendicitis
|
0.40%
1/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.41%
1/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.40%
1/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extramammary Paget's disease
|
0.00%
0/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.41%
1/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.41%
1/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.40%
1/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.41%
1/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
Other adverse events
| Measure |
Brexpiprazole 1 mg
n=250 participants at risk
Participants received brexpiprazole 1 mg tablet once daily for 6 weeks.
|
Brexpiprazole 2 mg
n=246 participants at risk
Participants received brexpiprazole 1 mg tablet once daily for 1 week followed by 2 mg tablet once daily for 5 weeks.
|
Placebo
n=244 participants at risk
Participants received placebo tablet once daily for 6 weeks.
|
|---|---|---|---|
|
Endocrine disorders
Hyperprolactinaemia
|
1.2%
3/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
5.3%
13/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.2%
3/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
5/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.7%
9/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.0%
5/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
6/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.8%
7/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.9%
7/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.40%
1/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.3%
8/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.5%
6/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.80%
2/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.4%
6/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.41%
1/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
General disorders
Malaise
|
0.40%
1/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.8%
7/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.82%
2/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
General disorders
Pyrexia
|
2.8%
7/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.41%
1/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.5%
6/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.2%
3/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.3%
8/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.5%
6/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
20/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
6.5%
16/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
9.8%
24/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
8/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.8%
7/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.6%
4/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
6/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.6%
4/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.2%
3/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.80%
2/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.7%
9/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.0%
5/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Blood insulin increased
|
2.0%
5/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.4%
6/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.41%
1/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Blood prolactin increased
|
2.4%
6/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
6.1%
15/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.5%
6/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.4%
6/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.2%
3/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.2%
3/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Weight increased
|
7.2%
18/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
7.7%
19/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.5%
6/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.2%
3/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.4%
6/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.41%
1/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.80%
2/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.0%
5/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.6%
4/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
1.2%
3/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.0%
5/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.41%
1/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Akathisia
|
6.0%
15/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
24.4%
60/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.2%
3/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
1.6%
4/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.0%
5/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.5%
6/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.40%
1/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
4.5%
11/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.82%
2/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Headache
|
2.4%
6/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.2%
3/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
4.5%
11/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Somnolence
|
1.2%
3/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.3%
8/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.5%
6/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Tremor
|
6.4%
16/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
4.9%
12/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.7%
9/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
3.6%
9/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
4.9%
12/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.3%
8/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Vascular disorders
Hypertension
|
3.2%
8/250 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.4%
6/246 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/244 • Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).
Subjects who received at least one dose of IMP were included in the safety analysis.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place