Trial Outcomes & Findings for Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder (NCT NCT00797966)
NCT ID: NCT00797966
Last Updated: 2016-02-29
Results Overview
The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
850 participants
Primary outcome timeframe
Week 8 to Week 14
Results posted on
2016-02-29
Participant Flow
This study was a Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of OPC-34712 as adjunctive therapy in the treatment of participants with major depressive disorder. This study was conducted in the United States at 50 study centers.
The study consisted of a 28-day Screening period, an 8-Week single-blind placebo + Antidepressant therapy (ADT) prospective Phase A. A 6-week double-blind Randomization Phase (Phase B) or single-blind Phase A+ for those participants who did not meet criteria for randomization and a Follow-up of 30 (+2) days after the last dose of study medication.
Participant milestones
| Measure |
OPC-34712 0.15 mg Fixed Dose
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Participants in Phase A
Participants entered Phase A (single-blind prospective treatment) during which participants had received single-blind placebo plus an open-label commercially available ADT for 8 weeks at maximally tolerated doses.
|
Participants in Phase A+
Based on the response at Week 8 (in Phase A), participants were either randomized to Phase B or continued single-blind treatment in Phase A+. Participants who met the criteria for a response at Week 8 were not to be randomized into Phase B but continued to receive single-blind placebo plus the maximum tolerated dose of ADT from Week 8 for an additional 6 weeks in Phase A+.
|
|---|---|---|---|---|---|---|
|
Phase A
STARTED
|
0
|
0
|
0
|
0
|
849
|
0
|
|
Phase A
COMPLETED
|
0
|
0
|
0
|
0
|
664
|
0
|
|
Phase A
NOT COMPLETED
|
0
|
0
|
0
|
0
|
185
|
0
|
|
Phase B
STARTED
|
62
|
120
|
121
|
126
|
0
|
0
|
|
Phase B
COMPLETED
|
51
|
102
|
100
|
110
|
0
|
0
|
|
Phase B
NOT COMPLETED
|
11
|
18
|
21
|
16
|
0
|
0
|
|
Phase A+
STARTED
|
0
|
0
|
0
|
0
|
0
|
235
|
|
Phase A+
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
207
|
|
Phase A+
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
28
|
Reasons for withdrawal
| Measure |
OPC-34712 0.15 mg Fixed Dose
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Participants in Phase A
Participants entered Phase A (single-blind prospective treatment) during which participants had received single-blind placebo plus an open-label commercially available ADT for 8 weeks at maximally tolerated doses.
|
Participants in Phase A+
Based on the response at Week 8 (in Phase A), participants were either randomized to Phase B or continued single-blind treatment in Phase A+. Participants who met the criteria for a response at Week 8 were not to be randomized into Phase B but continued to receive single-blind placebo plus the maximum tolerated dose of ADT from Week 8 for an additional 6 weeks in Phase A+.
|
|---|---|---|---|---|---|---|
|
Phase A
Lost to Follow-up
|
0
|
0
|
0
|
0
|
33
|
0
|
|
Phase A
Adverse Event
|
0
|
0
|
0
|
0
|
46
|
0
|
|
Phase A
Met withdrawal criteria
|
0
|
0
|
0
|
0
|
4
|
0
|
|
Phase A
Physician Decision
|
0
|
0
|
0
|
0
|
13
|
0
|
|
Phase A
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
33
|
0
|
|
Phase A
Protocol deviation
|
0
|
0
|
0
|
0
|
56
|
0
|
|
Phase B
Lost to Follow-up
|
0
|
1
|
3
|
0
|
0
|
0
|
|
Phase B
Adverse Event
|
2
|
1
|
3
|
1
|
0
|
0
|
|
Phase B
Met Withdrawal Criteria
|
3
|
3
|
6
|
1
|
0
|
0
|
|
Phase B
Physician Decision
|
1
|
0
|
3
|
1
|
0
|
0
|
|
Phase B
Withdrawal by Subject
|
1
|
4
|
3
|
3
|
0
|
0
|
|
Phase B
Protocol Deviation
|
4
|
8
|
2
|
6
|
0
|
0
|
|
Phase B
Lack of Efficacy
|
0
|
1
|
1
|
4
|
0
|
0
|
|
Phase A+
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Phase A+
Met withdrawal criteria
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Phase A+
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Phase A+
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
4
|
|
Phase A+
Protocol deviation
|
0
|
0
|
0
|
0
|
0
|
4
|
Baseline Characteristics
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=120 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=121 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Total
n=429 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
44.0 Years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
43.7 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
43.3 Years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
43.7 Years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
289 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 8 to Week 14Population: Intent-to-Treat (ITT) dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The Last Observation Carried Forward (LOCF) method was used to impute missing data.
The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=119 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=118 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
|
-6.62 Units on a scale
Standard Error 0.99
|
-6.46 Units on a scale
Standard Error 0.73
|
-8.23 Units on a scale
Standard Error 0.74
|
-6.09 Units on a scale
Standard Error 0.72
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
CGI-S items are: 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. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=119 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=118 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
|
-0.83 Units on a scale
Standard Error 0.13
|
-0.81 Units on a scale
Standard Error 0.10
|
-1.06 Units on a scale
Standard Error 0.10
|
-0.71 Units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
The Q-LES-Q is a self-report measure to enable physicians to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. The Overall-General Subscore will be defined by summing the scores on all 14 items and expressing it as the percent of the maximum possible score. When expressing the total score as a percentage, if items are left blank the range will be modified to reflect the number of items scored. Raw score is sum of non-missing ratings from items 1 to 14. Minimum score is number of non-missing items. Maximum score is 5\*(minimum score). Range is maximum score minus minimum score. Total score is 100\*(Raw score minus minimum score)/ Range, rounded to nearest integer.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=61 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=112 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=113 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=120 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).
|
7.60 Percentage of maximum possible score
Standard Error 1.82
|
6.53 Percentage of maximum possible score
Standard Error 1.38
|
7.46 Percentage of maximum possible score
Standard Error 1.38
|
5.92 Percentage of maximum possible score
Standard Error 1.34
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
The Sheehan Disability Scale (SDS) is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=61 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=111 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=113 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=120 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).
|
-0.84 Units on a scale
Standard Error 0.27
|
-0.80 Units on a scale
Standard Error 0.21
|
-1.27 Units on a scale
Standard Error 0.20
|
-0.61 Units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Week 8 to each of Week 9, 10, 11, 12 and 13.Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
The MADRS is utilized as the primary efficacy assessment of a patient's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=119 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=118 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 12 (N=62,119,118,126)
|
-6.97 Units on a scale
Standard Deviation 7.65
|
-6.31 Units on a scale
Standard Deviation 6.72
|
-7.01 Units on a scale
Standard Deviation 7.58
|
-4.41 Units on a scale
Standard Deviation 6.74
|
|
Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 13 (N=62,119,118,126)
|
-6.90 Units on a scale
Standard Deviation 7.71
|
-6.76 Units on a scale
Standard Deviation 7.20
|
-7.18 Units on a scale
Standard Deviation 7.64
|
-5.47 Units on a scale
Standard Deviation 7.47
|
|
Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 9 (N=61,117,116,121)
|
-2.13 Units on a scale
Standard Deviation 5.22
|
-3.00 Units on a scale
Standard Deviation 5.13
|
-2.75 Units on a scale
Standard Deviation 5.32
|
-2.48 Units on a scale
Standard Deviation 5.43
|
|
Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 10 (N=62,119,118,126)
|
-3.69 Units on a scale
Standard Deviation 5.34
|
-3.78 Units on a scale
Standard Deviation 6.27
|
-4.97 Units on a scale
Standard Deviation 6.48
|
-3.64 Units on a scale
Standard Deviation 6.65
|
|
Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 11 (N=62,119,118,126)
|
-5.53 Units on a scale
Standard Deviation 7.24
|
-5.71 Units on a scale
Standard Deviation 7.15
|
-5.88 Units on a scale
Standard Deviation 7.09
|
-4.40 Units on a scale
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: Week 8 to each of Week 9, 10, 11, 12 and 13.Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
CGI-S items are: 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. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=119 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=118 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 9 (N=62,117,116,121)
|
-0.21 Units on a scale
Standard Deviation 0.60
|
-0.26 Units on a scale
Standard Deviation 0.57
|
-0.33 Units on a scale
Standard Deviation 0.64
|
-0.21 Units on a scale
Standard Deviation 0.58
|
|
Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 12 (N=62,119,118,126)
|
-0.76 Units on a scale
Standard Deviation 1.02
|
-0.66 Units on a scale
Standard Deviation 0.87
|
-0.86 Units on a scale
Standard Deviation 1.00
|
-0.52 Units on a scale
Standard Deviation 0.98
|
|
Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 13 (N=62,119,118,126)
|
-0.74 Units on a scale
Standard Deviation 1.09
|
-0.78 Units on a scale
Standard Deviation 0.95
|
-0.88 Units on a scale
Standard Deviation 1.01
|
-0.59 Units on a scale
Standard Deviation 1.04
|
|
Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 11 (N=62,119,118,126)
|
-0.53 Units on a scale
Standard Deviation 0.95
|
-0.53 Units on a scale
Standard Deviation 0.84
|
-0.69 Units on a scale
Standard Deviation 0.92
|
-0.47 Units on a scale
Standard Deviation 0.89
|
|
Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 10 (N=62,119,118,126)
|
-0.42 Units on a scale
Standard Deviation 0.74
|
-0.39 Units on a scale
Standard Deviation 0.77
|
-0.61 Units on a scale
Standard Deviation 0.91
|
-0.40 Units on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 15 (Satisfaction with Medication) will yield a separate subscore.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=61 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=111 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=113 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=120 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).
|
0.02 Units on a scale
Standard Deviation 0.22
|
0.01 Units on a scale
Standard Deviation 0.25
|
0.02 Units on a scale
Standard Deviation 0.33
|
0.00 Units on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 16 (Overall Life Satisfaction) will yield a separate subscore.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=61 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=112 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=113 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=120 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).
|
0.30 Units on a scale
Standard Deviation 0.84
|
0.30 Units on a scale
Standard Deviation 0.79
|
0.35 Units on a scale
Standard Deviation 0.93
|
0.28 Units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
The IDS-SR is a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items are recorded. If the number of items was at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=119 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=118 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
Week 9 (N=61, 117,116,121)
|
-0.98 Units on a scale
Standard Deviation 7.28
|
-1.88 Units on a scale
Standard Deviation 6.60
|
-2.04 Units on a scale
Standard Deviation 5.93
|
-0.98 Units on a scale
Standard Deviation 7.58
|
|
Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
Week 10 (N=62, 119, 118, 126)
|
-2.13 Units on a scale
Standard Deviation 8.02
|
-2.58 Units on a scale
Standard Deviation 7.37
|
-4.08 Units on a scale
Standard Deviation 7.25
|
-1.62 Units on a scale
Standard Deviation 7.76
|
|
Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
Week 11 (N=62, 119, 118, 126)
|
-3.58 Units on a scale
Standard Deviation 7.81
|
-3.41 Units on a scale
Standard Deviation 7.88
|
-4.82 Units on a scale
Standard Deviation 7.96
|
-2.09 Units on a scale
Standard Deviation 8.42
|
|
Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
Week 12 (N=62, 119, 118, 126)
|
-5.11 Units on a scale
Standard Deviation 9.42
|
-3.77 Units on a scale
Standard Deviation 8.45
|
-5.77 Units on a scale
Standard Deviation 9.26
|
-2.07 Units on a scale
Standard Deviation 8.42
|
|
Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
Week 13 (N=62, 119, 118, 126)
|
-5.34 Units on a scale
Standard Deviation 9.15
|
-5.22 Units on a scale
Standard Deviation 8.72
|
-5.65 Units on a scale
Standard Deviation 8.84
|
-2.37 Units on a scale
Standard Deviation 8.45
|
|
Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
Week 14 (N=62, 119, 118, 126)
|
-5.55 Units on a scale
Standard Deviation 9.65
|
-4.96 Units on a scale
Standard Deviation 9.37
|
-6.74 Units on a scale
Standard Deviation 9.76
|
-3.08 Units on a scale
Standard Deviation 9.32
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
The HAM-D17 is utilized as a secondary assessment of a participant's level of depression. The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the "best" rating and the highest score (2 or 4) is the "worst" rating. The possible total scores are from 0 to 52.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=48 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=98 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=101 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=109 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.
|
-5.77 Units on a scale
Standard Error 0.86
|
-5.28 Units on a scale
Standard Error 0.63
|
-6.59 Units on a scale
Standard Error 0.62
|
-5.23 Units on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
CGI-I items are: 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. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI-I was assessed at each visit in Phase B, and improvement is judged with respect to the participant's condition at baseline. CGI-I was also assessed at each visit in Phase B, but in that phase improvement is judged with respect to the partcipant's condition at the end of Phase A.
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=119 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=118 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
Week 12 (N=62, 119, 118, 126)
|
2.87 Units on a scale
Standard Deviation 1.06
|
2.90 Units on a scale
Standard Deviation 0.99
|
2.70 Units on a scale
Standard Deviation 1.03
|
2.95 Units on a scale
Standard Deviation 1.06
|
|
Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
Week 9 (N=62, 117, 116, 121)
|
3.39 Units on a scale
Standard Deviation 0.86
|
3.30 Units on a scale
Standard Deviation 0.79
|
3.20 Units on a scale
Standard Deviation 0.80
|
3.31 Units on a scale
Standard Deviation 0.79
|
|
Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
Week 10 (N=62, 119, 118, 126)
|
3.16 Units on a scale
Standard Deviation 0.94
|
3.19 Units on a scale
Standard Deviation 0.90
|
2.95 Units on a scale
Standard Deviation 0.93
|
3.11 Units on a scale
Standard Deviation 1.04
|
|
Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
Week 14 (N=62, 119, 118, 126)
|
2.74 Units on a scale
Standard Deviation 1.16
|
2.78 Units on a scale
Standard Deviation 1.02
|
2.52 Units on a scale
Standard Deviation 1.08
|
2.83 Units on a scale
Standard Deviation 1.12
|
|
Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
Week 11 (N=62, 119, 118, 126)
|
2.94 Units on a scale
Standard Deviation 0.94
|
3.02 Units on a scale
Standard Deviation 0.98
|
2.80 Units on a scale
Standard Deviation 0.92
|
2.94 Units on a scale
Standard Deviation 1.01
|
|
Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
Week 13 (N=62, 119, 118, 126)
|
2.85 Units on a scale
Standard Deviation 1.13
|
2.76 Units on a scale
Standard Deviation 1.02
|
2.64 Units on a scale
Standard Deviation 1.06
|
2.90 Units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
A MADRS response was defined as \>/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=119 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=118 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
Week 9 (N=61, 117, 116, 121)
|
4.92 Percentage of participants
|
6.84 Percentage of participants
|
2.59 Percentage of participants
|
8.26 Percentage of participants
|
|
Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
Week 10 (N=62, 119, 118, 126)
|
8.06 Percentage of participants
|
8.40 Percentage of participants
|
11.0 Percentage of participants
|
9.52 Percentage of participants
|
|
Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
Week 11 (N=62, 119, 118, 126)
|
19.4 Percentage of participants
|
15.1 Percentage of participants
|
18.6 Percentage of participants
|
13.5 Percentage of participants
|
|
Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
Week 12 (N=62, 119, 118, 126)
|
30.6 Percentage of participants
|
15.1 Percentage of participants
|
25.4 Percentage of participants
|
11.9 Percentage of participants
|
|
Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
Week 13 (N=62, 119, 118, 126)
|
24.2 Percentage of participants
|
22.7 Percentage of participants
|
25.4 Percentage of participants
|
18.3 Percentage of participants
|
|
Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
Week 14 (N=62, 119, 118, 126)
|
27.4 Percentage of participants
|
20.2 Percentage of participants
|
34.7 Percentage of participants
|
19.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
A MADRS remission was defined as MADRS Total Score \</= 10 and \>/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=119 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=118 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
Week 9 (N=61, 117, 116, 121)
|
3.28 Percentage of participants
|
1.71 Percentage of participants
|
1.72 Percentage of participants
|
4.13 Percentage of participants
|
|
Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
Week 10 (N=62, 119, 118, 126)
|
8.06 Percentage of participants
|
5.04 Percentage of participants
|
10.2 Percentage of participants
|
8.73 Percentage of participants
|
|
Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
Week 11 (N=62, 119, 118, 126)
|
12.9 Percentage of participants
|
10.1 Percentage of participants
|
14.4 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
Week 12 (N=62, 119, 118, 126)
|
21.0 Percentage of participants
|
10.1 Percentage of participants
|
19.5 Percentage of participants
|
10.3 Percentage of participants
|
|
Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
Week 13 (N=62, 119, 118, 126)
|
19.4 Percentage of participants
|
16.8 Percentage of participants
|
15.3 Percentage of participants
|
15.1 Percentage of participants
|
|
Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
Week 14 (N=62, 119, 118, 126)
|
22.6 Percentage of participants
|
15.1 Percentage of participants
|
23.7 Percentage of participants
|
13.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 9, 10, 11, 12, 13 and 14.Population: ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.
CGI-I response is defined as CGI-I of 1 \[very much improved\] or 2 \[much improved\].
Outcome measures
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 Participants
The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=119 Participants
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=118 Participants
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 Participants
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
Week 9 (N=62, 117, 116, 121)
|
16.1 percentage of participants
|
11.1 percentage of participants
|
14.7 percentage of participants
|
14.9 percentage of participants
|
|
Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
Week 10 (N=62, 119, 118, 126)
|
25.8 percentage of participants
|
17.6 percentage of participants
|
24.6 percentage of participants
|
27.0 percentage of participants
|
|
Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
Week 11 (N=62, 119, 118, 126)
|
32.3 percentage of participants
|
29.4 percentage of participants
|
35.6 percentage of participants
|
29.4 percentage of participants
|
|
Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
Week 12 (N=62, 119, 118, 126)
|
35.5 percentage of participants
|
33.6 percentage of participants
|
42.4 percentage of participants
|
31.7 percentage of participants
|
|
Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
Week 13 (N=62, 119, 118, 126)
|
37.1 percentage of participants
|
37.0 percentage of participants
|
49.2 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
Week 14 (N=62, 119, 118, 126)
|
38.7 percentage of participants
|
37.0 percentage of participants
|
52.5 percentage of participants
|
41.3 percentage of participants
|
Adverse Events
OPC-34712 0.15 mg Fixed Dose
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
OPC-34712 0.5 ± 0.25 mg Low Dose
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
OPC-34712 1.5 ± 0.5 mg High Dose
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 participants at risk
The participants received 0.15 mg/day OPC-34712 along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=120 participants at risk
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=121 participants at risk
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 participants at risk
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.00%
0/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.83%
1/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.00%
0/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.00%
0/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.83%
1/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.00%
0/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.00%
0/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.00%
0/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.79%
1/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.00%
0/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.83%
1/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.00%
0/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
Other adverse events
| Measure |
OPC-34712 0.15 mg Fixed Dose
n=62 participants at risk
The participants received 0.15 mg/day OPC-34712 along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 0.5 ± 0.25 mg Low Dose
n=120 participants at risk
The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
OPC-34712 1.5 ± 0.5 mg High Dose
n=121 participants at risk
The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
Placebo
n=126 participants at risk
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.00%
0/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
8.3%
10/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
4.0%
5/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
5.8%
7/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
1.7%
2/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
2.4%
3/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
3/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
5.8%
7/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
4.1%
5/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
1.6%
2/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
4/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
8.3%
10/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
5.8%
7/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
4.8%
6/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Investigations
Weight increased
|
4.8%
3/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
5.8%
7/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
7.4%
9/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.79%
1/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Nervous system disorders
Akathisia
|
6.5%
4/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
5.0%
6/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
8.3%
10/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
3.2%
4/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Psychiatric disorders
Insomnia
|
8.1%
5/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
2.5%
3/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
3.3%
4/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
3.2%
4/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Psychiatric disorders
Restlessness
|
6.5%
4/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
0.83%
1/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
4.1%
5/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
4.8%
6/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
|
Nervous system disorders
Headache
|
8.1%
5/62 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
7.5%
9/120 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
5.0%
6/121 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
9.5%
12/126 • From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development & Commercialization, Inc
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place