Trial Outcomes & Findings for Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder (NCT NCT02046564)
NCT ID: NCT02046564
Last Updated: 2018-05-21
Results Overview
The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists 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 is scored from 0 to 6, with higher scores indicating worse condition.Summed subscales are combined to compute a total score. Total score ranges from 0 to 60, with higher score indicating worse condition.
COMPLETED
PHASE3
412 participants
8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])
2018-05-21
Participant Flow
Participant milestones
| Measure |
ASC-01
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
203
|
|
Overall Study
COMPLETED
|
194
|
183
|
|
Overall Study
NOT COMPLETED
|
15
|
20
|
Reasons for withdrawal
| Measure |
ASC-01
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
|
Overall Study
Subject met withdrawal criteria
|
2
|
5
|
Baseline Characteristics
Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
ASC-01
n=208 Participants
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=203 Participants
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
208 Participants
n=93 Participants
|
203 Participants
n=4 Participants
|
411 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 11.8 • n=93 Participants
|
39.5 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
38.9 years
STANDARD_DEVIATION 11.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=93 Participants
|
131 Participants
n=4 Participants
|
260 Participants
n=27 Participants
|
|
Region of Enrollment
South Korea
|
36 participants
n=93 Participants
|
42 participants
n=4 Participants
|
78 participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
157 participants
n=93 Participants
|
142 participants
n=4 Participants
|
299 participants
n=27 Participants
|
|
Region of Enrollment
Taiwan
|
7 participants
n=93 Participants
|
10 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Region of Enrollment
Malaysia
|
6 participants
n=93 Participants
|
5 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
6 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists 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 is scored from 0 to 6, with higher scores indicating worse condition.Summed subscales are combined to compute a total score. Total score ranges from 0 to 60, with higher score indicating worse condition.
Outcome measures
| Measure |
ASC-01
n=208 Participants
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=203 Participants
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
|
-9.2 units on a scale
Standard Error 0.5
|
-7.2 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: 8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists 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 is scored from 0 to 6, with higher scores indicating worse condition. MADRS Response Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more.
Outcome measures
| Measure |
ASC-01
n=208 Participants
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=203 Participants
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate
|
37.5 percentage of participants
|
25.6 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists 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 is scored from 0 to 6, with higher scores indicating worse condition. MADRS Remission Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more and whose MADRS total score is 10 points or less.
Outcome measures
| Measure |
ASC-01
n=208 Participants
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=203 Participants
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate
|
29.3 percentage of participants
|
20.2 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])The CGI-I Scale is a clinician-rated scale which assesses the total improvement of the patient'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 indicate worse condition. CGI-I Improvement Rate is the percentage of subjects whose CGI-I score is 1 or 2.
Outcome measures
| Measure |
ASC-01
n=208 Participants
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=203 Participants
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
The Clinical Global Impression - Improvement (CGI-I) Improvement Rate
|
46.2 percentage of participants
|
34.5 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])The CGI-S Scale is a clinician-rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 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, 7= Among the most extremely ill patients. Higher scores indicate worse condition.
Outcome measures
| Measure |
ASC-01
n=208 Participants
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=203 Participants
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
The Mean Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S)
|
-1.0 units on a scale
Standard Error 0.1
|
-0.8 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])The HAM-D is a clinician-rated scale which evaluates the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on. Each item is scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 52, with higher score indicating worse condition.
Outcome measures
| Measure |
ASC-01
n=208 Participants
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=203 Participants
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
The Mean Change From Baseline in the Hamilton Depression Rating Scale 17 (HAM-D17) Total Score
|
-6.8 units on a scale
Standard Error 0.4
|
-5.6 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: 8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])The SASS is a self-rating scale which assesses the social motivation and behavior in participants with depression. The SASS consists of 21 items covering the different aspects of social interactions, global social attitude, and self-perception. Each item is scored from 0 to 3, with higher scores indicating better condition.
Outcome measures
| Measure |
ASC-01
n=164 Participants
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=149 Participants
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
The Mean Change From Baseline in the Social Adaptation Self-evaluation Scale (SASS) Total Score
|
3.7 units on a scale
Standard Error 0.3
|
1.5 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: 8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])The AS consists of 14 items. Items 1-8 are scored as follows: 3= Not at all, 2= Slightly, 1= Some, 0= A lot. Items 9-14 are scored as follows: 0= Not at all, 1= Slightly, 2= Some, 3= A lot. Total score ranges from 0-42, with higher score indicating worse condition.
Outcome measures
| Measure |
ASC-01
n=164 Participants
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=149 Participants
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
The Mean Change From Baseline in the Apathy Scale (AS) Total Score
|
-3.3 units on a scale
Standard Error 0.4
|
-1.1 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: 8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])The MADRS-S is a patient-reported scale based on MADRS, administered to evaluate the level of depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored from 0 to 3, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 27, with higher score indicating worse condition.
Outcome measures
| Measure |
ASC-01
n=208 Participants
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=203 Participants
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
The Mean Change From Baseline in the Self-rating Version of Montgomery-Åsberg Depression Rating Scale (MADRS-S) Total Score
|
-2.85 units on a scale
Standard Error 0.22
|
-1.86 units on a scale
Standard Error 0.23
|
Adverse Events
ASC-01
Placebo
Serious adverse events
| Measure |
ASC-01
n=209 participants at risk
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=203 participants at risk
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/209 • Double-blind period (6 weeks)
|
0.49%
1/203 • Number of events 1 • Double-blind period (6 weeks)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/209 • Double-blind period (6 weeks)
|
0.49%
1/203 • Number of events 1 • Double-blind period (6 weeks)
|
Other adverse events
| Measure |
ASC-01
n=209 participants at risk
* Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet
* Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet
* Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet
* Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
|
Placebo
n=203 participants at risk
The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.4%
5/209 • Double-blind period (6 weeks)
|
2.0%
4/203 • Double-blind period (6 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.96%
2/209 • Double-blind period (6 weeks)
|
2.0%
4/203 • Double-blind period (6 weeks)
|
|
Gastrointestinal disorders
Nausea
|
4.3%
9/209 • Double-blind period (6 weeks)
|
4.9%
10/203 • Double-blind period (6 weeks)
|
|
Gastrointestinal disorders
Stomatitis
|
0.48%
1/209 • Double-blind period (6 weeks)
|
2.0%
4/203 • Double-blind period (6 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
5/209 • Double-blind period (6 weeks)
|
1.5%
3/203 • Double-blind period (6 weeks)
|
|
General disorders
Drug withdrawal syndrome
|
2.4%
5/209 • Double-blind period (6 weeks)
|
1.5%
3/203 • Double-blind period (6 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
13.4%
28/209 • Double-blind period (6 weeks)
|
11.3%
23/203 • Double-blind period (6 weeks)
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
6/209 • Double-blind period (6 weeks)
|
0.99%
2/203 • Double-blind period (6 weeks)
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
5/209 • Double-blind period (6 weeks)
|
0.49%
1/203 • Double-blind period (6 weeks)
|
|
Investigations
Weight increased
|
4.3%
9/209 • Double-blind period (6 weeks)
|
0.49%
1/203 • Double-blind period (6 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.48%
1/209 • Double-blind period (6 weeks)
|
2.0%
4/203 • Double-blind period (6 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/209 • Double-blind period (6 weeks)
|
2.5%
5/203 • Double-blind period (6 weeks)
|
|
Nervous system disorders
Akathisia
|
12.9%
27/209 • Double-blind period (6 weeks)
|
3.4%
7/203 • Double-blind period (6 weeks)
|
|
Nervous system disorders
Dizziness
|
4.8%
10/209 • Double-blind period (6 weeks)
|
4.9%
10/203 • Double-blind period (6 weeks)
|
|
Nervous system disorders
Headache
|
3.8%
8/209 • Double-blind period (6 weeks)
|
6.4%
13/203 • Double-blind period (6 weeks)
|
|
Nervous system disorders
Somnolence
|
2.4%
5/209 • Double-blind period (6 weeks)
|
2.5%
5/203 • Double-blind period (6 weeks)
|
|
Nervous system disorders
Tremor
|
5.7%
12/209 • Double-blind period (6 weeks)
|
5.4%
11/203 • Double-blind period (6 weeks)
|
|
Psychiatric disorders
Insomnia
|
4.3%
9/209 • Double-blind period (6 weeks)
|
2.5%
5/203 • Double-blind period (6 weeks)
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co. Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place