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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00797966
First received: November 24, 2008
Last updated: February 2, 2016
Last verified: February 2016
Results First Received: August 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: OPC-34712
Drug: Placebo
Drug: ADT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
OPC-34712 0.15 mg Fixed Dose The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OPC-34712 0.5 ± 0.25 mg Low Dose The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OPC-34712 1.5 ± 0.5 mg High Dose The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Placebo The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Participants in Phase A Participants entered Phase A (single-blind prospective treatment) during which participants had received single-blind placebo plus an open-label commercially available ADT for 8 weeks at maximally tolerated doses.
Participants in Phase A+ Based on the response at Week 8 (in Phase A), participants were either randomized to Phase B or continued single-blind treatment in Phase A+. Participants who met the criteria for a response at Week 8 were not to be randomized into Phase B but continued to receive single-blind placebo plus the maximum tolerated dose of ADT from Week 8 for an additional 6 weeks in Phase A+.

Participant Flow for 3 periods

Period 1:   Phase A
    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+  
STARTED     0     0     0     0     849 [1]   0  
COMPLETED     0     0     0     0     664     0  
NOT COMPLETED     0     0     0     0     185     0  
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 2:   Phase B
    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+  
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  
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 3:   Phase A+
    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+  
STARTED     0     0     0     0     0     235  
COMPLETED     0     0     0     0     0     207  
NOT COMPLETED     0     0     0     0     0     28  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
OPC-34712 0.15 mg Fixed Dose The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OPC-34712 0.5 ± 0.25 mg Low Dose The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
OPC-34712 1.5 ± 0.5 mg High Dose The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Placebo The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
Total Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  62     120     121     126     429  
Age  
[units: Years]
Mean (Standard Deviation)
  43.9  (10.8)     44.0  (11.8)     43.7  (11.6)     43.3  (11.5)     43.7  (11.5)  
Gender  
[units: Participants]
         
Female     41     86     80     82     289  
Male     21     34     41     44     140  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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.   [ Time Frame: Week 8 to Week 14 ]

2.  Secondary:   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.   [ Time Frame: Week 8 to Week 14 ]

3.  Secondary:   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).   [ Time Frame: Week 8 to Week 14 ]

4.  Secondary:   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).   [ Time Frame: Week 8 to Week 14 ]

5.  Secondary:   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.   [ Time Frame: Week 8 to each of Week 9, 10, 11, 12 and 13. ]

6.  Secondary:   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.   [ Time Frame: Week 8 to each of Week 9, 10, 11, 12 and 13. ]

7.  Secondary:   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).   [ Time Frame: Week 8 to Week 14 ]

8.  Secondary:   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).   [ Time Frame: Week 8 to Week 14 ]

9.  Secondary:   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.   [ Time Frame: Week 8 to each of Week 9, 10, 11, 12, 13 and 14 ]

10.  Secondary:   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.   [ Time Frame: Week 8 to Week 14 ]

11.  Secondary:   Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.   [ Time Frame: Week 8 to each of Week 9, 10, 11, 12, 13 and 14. ]

12.  Secondary:   Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).   [ Time Frame: Week 8 to each of Week 9, 10, 11, 12, 13 and 14. ]

13.  Secondary:   Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).   [ Time Frame: Week 8 to each of Week 9, 10, 11, 12, 13 and 14. ]

14.  Secondary:   Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).   [ Time Frame: Week 9, 10, 11, 12, 13 and 14. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc
phone: 800 562-3974



Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00797966     History of Changes
Other Study ID Numbers: 331-08-211
Study First Received: November 24, 2008
Results First Received: August 7, 2015
Last Updated: February 2, 2016
Health Authority: United States: Food and Drug Administration