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Trial record 47 of 889 for:    "Depressive Disorder" [DISEASE] AND MADRS

Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00797966
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : December 3, 2015
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: OPC-34712
Drug: Placebo
Drug: ADT
Enrollment 850
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo Participants in Phase A Participants in Phase A+
Hide Arm/Group Description 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. 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. 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. 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 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. 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+.
Period Title: Phase A
Started 0 0 0 0 849 [1] 0
Completed 0 0 0 0 664 0
Not Completed 0 0 0 0 185 0
Reason Not Completed
Lost to Follow-up             0             0             0             0             33             0
Adverse Event             0             0             0             0             46             0
Met withdrawal criteria             0             0             0             0             4             0
Physician Decision             0             0             0             0             13             0
Withdrawal by Subject             0             0             0             0             33             0
Protocol deviation             0             0             0             0             56             0
[1]
850 participants entered Phase A; 849 participants were treated.
Period Title: Phase B
Started 62 [1] 120 [1] 121 [1] 126 [1] 0 0
Completed 51 102 100 110 0 0
Not Completed 11 18 21 16 0 0
Reason Not Completed
Lost to Follow-up             0             1             3             0             0             0
Adverse Event             2             1             3             1             0             0
Met Withdrawal Criteria             3             3             6             1             0             0
Physician Decision             1             0             3             1             0             0
Withdrawal by Subject             1             4             3             3             0             0
Protocol Deviation             4             8             2             6             0             0
Lack of Efficacy             0             1             1             4             0             0
[1]
Randomized participants.
Period Title: Phase A+
Started 0 0 0 0 0 235
Completed 0 0 0 0 0 207
Not Completed 0 0 0 0 0 28
Reason Not Completed
Lost to Follow-up             0             0             0             0             0             9
Met withdrawal criteria             0             0             0             0             0             5
Withdrawal by Subject             0             0             0             0             0             6
Adverse Event             0             0             0             0             0             4
Protocol deviation             0             0             0             0             0             4
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo Total
Hide Arm/Group Description 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. 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 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. 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 of all reporting groups
Overall Number of Baseline Participants 62 120 121 126 429
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 120 participants 121 participants 126 participants 429 participants
43.9  (10.8) 44.0  (11.8) 43.7  (11.6) 43.3  (11.5) 43.7  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 120 participants 121 participants 126 participants 429 participants
Female
41
  66.1%
86
  71.7%
80
  66.1%
82
  65.1%
289
  67.4%
Male
21
  33.9%
34
  28.3%
41
  33.9%
44
  34.9%
140
  32.6%
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Week 8 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 62 119 118 126
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-6.62  (0.99) -6.46  (0.73) -8.23  (0.74) -6.09  (0.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg’s procedure for handling the two primary efficacy comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6551
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-2.87 to 1.81
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg’s procedure for handling the two primary efficacy comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7037
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-2.30 to 1.55
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg’s procedure for handling the two primary efficacy comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0303
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.14
Confidence Interval (2-Sided) 95%
-4.08 to -0.21
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Week 8 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 62 119 118 126
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.83  (0.13) -0.81  (0.10) -1.06  (0.10) -0.71  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4166
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.43 to 0.18
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4193
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.35 to 0.15
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.60 to -0.10
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
3.Secondary Outcome
Title 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).
Hide Description 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.
Time Frame Week 8 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 61 112 113 120
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of maximum possible score
7.60  (1.82) 6.53  (1.38) 7.46  (1.38) 5.92  (1.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4490
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.68
Confidence Interval (2-Sided) 95%
-2.67 to 6.02
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7412
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
-3.02 to 4.24
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4070
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
-2.10 to 5.17
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
4.Secondary Outcome
Title 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).
Hide Description 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.
Time Frame Week 8 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
Overall Number of Participants Analyzed 61 111 113 120
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.84  (0.27) -0.80  (0.21) -1.27  (0.20) -0.61  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4954
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.86 to 0.42
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4902
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.73 to 0.35
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0161
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.20 to -0.12
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
5.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Week 8 to each of Week 9, 10, 11, 12 and 13.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 62 119 118 126
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 9 (N=61,117,116,121) -2.13  (5.22) -3.00  (5.13) -2.75  (5.32) -2.48  (5.43)
Week 10 (N=62,119,118,126) -3.69  (5.34) -3.78  (6.27) -4.97  (6.48) -3.64  (6.65)
Week 11 (N=62,119,118,126) -5.53  (7.24) -5.71  (7.15) -5.88  (7.09) -4.40  (7.05)
Week 12 (N=62,119,118,126) -6.97  (7.65) -6.31  (6.72) -7.01  (7.58) -4.41  (6.74)
Week 13 (N=62,119,118,126) -6.90  (7.71) -6.76  (7.20) -7.18  (7.64) -5.47  (7.47)
6.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Week 8 to each of Week 9, 10, 11, 12 and 13.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 62 119 118 126
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 9 (N=62,117,116,121) -0.21  (0.60) -0.26  (0.57) -0.33  (0.64) -0.21  (0.58)
Week 10 (N=62,119,118,126) -0.42  (0.74) -0.39  (0.77) -0.61  (0.91) -0.40  (0.87)
Week 11 (N=62,119,118,126) -0.53  (0.95) -0.53  (0.84) -0.69  (0.92) -0.47  (0.89)
Week 12 (N=62,119,118,126) -0.76  (1.02) -0.66  (0.87) -0.86  (1.00) -0.52  (0.98)
Week 13 (N=62,119,118,126) -0.74  (1.09) -0.78  (0.95) -0.88  (1.01) -0.59  (1.04)
7.Secondary Outcome
Title 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).
Hide Description 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.
Time Frame Week 8 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 61 111 113 120
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.02  (0.22) 0.01  (0.25) 0.02  (0.33) 0.00  (0.22)
8.Secondary Outcome
Title 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).
Hide Description 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.
Time Frame Week 8 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 61 112 113 120
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.30  (0.84) 0.30  (0.79) 0.35  (0.93) 0.28  (1.00)
9.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Week 8 to each of Week 9, 10, 11, 12, 13 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 62 119 118 126
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 9 (N=61, 117,116,121) -0.98  (7.28) -1.88  (6.60) -2.04  (5.93) -0.98  (7.58)
Week 10 (N=62, 119, 118, 126) -2.13  (8.02) -2.58  (7.37) -4.08  (7.25) -1.62  (7.76)
Week 11 (N=62, 119, 118, 126) -3.58  (7.81) -3.41  (7.88) -4.82  (7.96) -2.09  (8.42)
Week 12 (N=62, 119, 118, 126) -5.11  (9.42) -3.77  (8.45) -5.77  (9.26) -2.07  (8.42)
Week 13 (N=62, 119, 118, 126) -5.34  (9.15) -5.22  (8.72) -5.65  (8.84) -2.37  (8.45)
Week 14 (N=62, 119, 118, 126) -5.55  (9.65) -4.96  (9.37) -6.74  (9.76) -3.08  (9.32)
10.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Week 8 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 48 98 101 109
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.77  (0.86) -5.28  (0.63) -6.59  (0.62) -5.23  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5953
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-2.54 to 1.46
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9479
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-1.66 to 1.55
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0919
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.36
Confidence Interval (2-Sided) 95%
-2.95 to 0.22
Estimation Comments Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.
11.Secondary Outcome
Title Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
Hide Description 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.
Time Frame Week 8 to each of Week 9, 10, 11, 12, 13 and 14.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 62 119 118 126
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 9 (N=62, 117, 116, 121) 3.39  (0.86) 3.30  (0.79) 3.20  (0.80) 3.31  (0.79)
Week 10 (N=62, 119, 118, 126) 3.16  (0.94) 3.19  (0.90) 2.95  (0.93) 3.11  (1.04)
Week 11 (N=62, 119, 118, 126) 2.94  (0.94) 3.02  (0.98) 2.80  (0.92) 2.94  (1.01)
Week 12 (N=62, 119, 118, 126) 2.87  (1.06) 2.90  (0.99) 2.70  (1.03) 2.95  (1.06)
Week 13 (N=62, 119, 118, 126) 2.85  (1.13) 2.76  (1.02) 2.64  (1.06) 2.90  (1.14)
Week 14 (N=62, 119, 118, 126) 2.74  (1.16) 2.78  (1.02) 2.52  (1.08) 2.83  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3998
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8838
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4012
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6131
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5964
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2540
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8524
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6969
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3108
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8719
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6105
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0709
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9574
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2310
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0672
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8441
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6741
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0183
Comments Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
Hide Description A MADRS response was defined as >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).
Time Frame Week 8 to each of Week 9, 10, 11, 12, 13 and 14.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 62 119 118 126
Measure Type: Number
Unit of Measure: Percentage of participants
Week 9 (N=61, 117, 116, 121) 4.92 6.84 2.59 8.26
Week 10 (N=62, 119, 118, 126) 8.06 8.40 11.0 9.52
Week 11 (N=62, 119, 118, 126) 19.4 15.1 18.6 13.5
Week 12 (N=62, 119, 118, 126) 30.6 15.1 25.4 11.9
Week 13 (N=62, 119, 118, 126) 24.2 22.7 25.4 18.3
Week 14 (N=62, 119, 118, 126) 27.4 20.2 34.7 19.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3007
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.12 to 1.93
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8812
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.42 to 2.10
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0553
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
0.10 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6051
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.30 to 2.05
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8264
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.46 to 1.85
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8690
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.54 to 2.10
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3441
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
0.74 to 2.44
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6375
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.67 to 1.94
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3135
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.78 to 2.21
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 2.35
Confidence Interval (2-Sided) 95%
1.32 to 4.18
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4358
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.70 to 2.31
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 2.02
Confidence Interval (2-Sided) 95%
1.20 to 3.41
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3968
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.72 to 2.23
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2990
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.81 to 2.00
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1614
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
0.86 to 2.25
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3254
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
0.79 to 2.12
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9463
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.64 to 1.62
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0080
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.74
Confidence Interval (2-Sided) 95%
1.14 to 2.65
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
Hide Description 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).
Time Frame Week 8 to each of Week 9, 10, 11, 12, 13 and 14.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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.
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 62 119 118 126
Measure Type: Number
Unit of Measure: Percentage of participants
Week 9 (N=61, 117, 116, 121) 3.28 1.71 1.72 4.13
Week 10 (N=62, 119, 118, 126) 8.06 5.04 10.2 8.73
Week 11 (N=62, 119, 118, 126) 12.9 10.1 14.4 11.1
Week 12 (N=62, 119, 118, 126) 21.0 10.1 19.5 10.3
Week 13 (N=62, 119, 118, 126) 19.4 16.8 15.3 15.1
Week 14 (N=62, 119, 118, 126) 22.6 15.1 23.7 13.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5791
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.09 to 3.90
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2653
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.10 to 1.93
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2259
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.08 to 1.87
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6986
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.32 to 2.18
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2339
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.28 to 1.35
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8615
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.53 to 2.15
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8807
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.51 to 2.20
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9035
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.52 to 1.77
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5898
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.64 to 2.24
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0840
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.82
Confidence Interval (2-Sided) 95%
0.93 to 3.58
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9115
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.49 to 1.88
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0522
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.77
Confidence Interval (2-Sided) 95%
0.98 to 3.17
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4997
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.65 to 2.34
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5846
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.69 to 1.93
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9602
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.55 to 1.76
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1254
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.62
Confidence Interval (2-Sided) 95%
0.87 to 3.02
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6670
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.65 to 1.99
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0525
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
0.98 to 2.93
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
Hide Description CGI-I response is defined as CGI-I of 1 [very much improved] or 2 [much improved].
Time Frame Week 9, 10, 11, 12, 13 and 14.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description:
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.
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
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.
The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Overall Number of Participants Analyzed 62 119 118 126
Measure Type: Number
Unit of Measure: percentage of participants
Week 9 (N=62, 117, 116, 121) 16.1 11.1 14.7 14.9
Week 10 (N=62, 119, 118, 126) 25.8 17.6 24.6 27.0
Week 11 (N=62, 119, 118, 126) 32.3 29.4 35.6 29.4
Week 12 (N=62, 119, 118, 126) 35.5 33.6 42.4 31.7
Week 13 (N=62, 119, 118, 126) 37.1 37.0 49.2 33.3
Week 14 (N=62, 119, 118, 126) 38.7 37.0 52.5 41.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9462
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.52 to 1.84
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4971
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.43 to 1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 9 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8118
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.53 to 1.63
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8323
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.59 to 1.53
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0930
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.43 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 10 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5530
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.59 to 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8007
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.69 to 1.61
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8945
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.71 to 1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 11 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3837
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.83 to 1.64
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7064
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.72 to 1.63
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7469
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.74 to 1.52
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 12 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0832
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.97 to 1.86
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6611
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.74 to 1.61
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4435
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.83 to 1.56
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 13 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0118
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
1.09 to 1.98
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.15 mg Fixed Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5111
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.63 to 1.26
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection OPC-34712 0.5 ± 0.25 mg Low Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4903
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.66 to 1.22
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection OPC-34712 1.5 ± 0.5 mg High Dose, Placebo
Comments Week 14 values presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0662
Comments Cochran-Mantel-Haenszel general association test controlling for study center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
0.98 to 1.67
Estimation Comments [Not Specified]
Time Frame From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
Adverse Event Reporting Description 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.
 
Arm/Group Title OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Hide Arm/Group Description The participants received 0.15 mg/day OPC-34712 along with the physician assigned ADT from Week 9 to Week 14/ Early Termination. 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. 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. The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
All-Cause Mortality
OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/120 (0.00%)   2/121 (1.65%)   1/126 (0.79%) 
Injury, poisoning and procedural complications         
Radius fracture * 1  0/62 (0.00%)  0/120 (0.00%)  1/121 (0.83%)  0/126 (0.00%) 
Ulna fracture * 1  0/62 (0.00%)  0/120 (0.00%)  1/121 (0.83%)  0/126 (0.00%) 
Renal and urinary disorders         
Renal mass * 1  0/62 (0.00%)  0/120 (0.00%)  0/121 (0.00%)  1/126 (0.79%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease * 1  0/62 (0.00%)  0/120 (0.00%)  1/121 (0.83%)  0/126 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OPC-34712 0.15 mg Fixed Dose OPC-34712 0.5 ± 0.25 mg Low Dose OPC-34712 1.5 ± 0.5 mg High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/62 (33.87%)   37/120 (30.83%)   47/121 (38.84%)   37/126 (29.37%) 
Gastrointestinal disorders         
Diarrhoea * 1  1/62 (1.61%)  0/120 (0.00%)  10/121 (8.26%)  5/126 (3.97%) 
Nausea * 1  0/62 (0.00%)  7/120 (5.83%)  2/121 (1.65%)  3/126 (2.38%) 
Infections and infestations         
Nasopharyngitis * 1  3/62 (4.84%)  7/120 (5.83%)  5/121 (4.13%)  2/126 (1.59%) 
Upper respiratory tract infection * 1  4/62 (6.45%)  10/120 (8.33%)  7/121 (5.79%)  6/126 (4.76%) 
Investigations         
Weight increased * 1  3/62 (4.84%)  7/120 (5.83%)  9/121 (7.44%)  1/126 (0.79%) 
Nervous system disorders         
Akathisia * 1  4/62 (6.45%)  6/120 (5.00%)  10/121 (8.26%)  4/126 (3.17%) 
Headache * 1  5/62 (8.06%)  9/120 (7.50%)  6/121 (4.96%)  12/126 (9.52%) 
Psychiatric disorders         
Insomnia * 1  5/62 (8.06%)  3/120 (2.50%)  4/121 (3.31%)  4/126 (3.17%) 
Restlessness * 1  4/62 (6.45%)  1/120 (0.83%)  5/121 (4.13%)  6/126 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc
Phone: 800 562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00797966     History of Changes
Other Study ID Numbers: 331-08-211
First Submitted: November 24, 2008
First Posted: November 25, 2008
Results First Submitted: August 7, 2015
Results First Posted: December 3, 2015
Last Update Posted: February 29, 2016