Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01447576
Recruitment Status : Completed
First Posted : October 6, 2011
Results First Posted : November 6, 2015
Last Update Posted : November 6, 2015
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: ADT
Drug: OPC-34712

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
1036 participants entered trial, including 792 who had rolled over from previous studies and 244 de novo participants. Of the 792 rollovers, 337 were 6-week enrollers and the 52-week enrollers consisted of 699 enrolled participants (455 rollover and 244 de novo). This was a single arm study and all participants received the same treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants received daily treatment with open-label brexpiprazole (0.25 up to 3.0 milligrams (mg)/day) and commercially marketed ADT.

Reporting Groups
Brexpiprazole +ADT All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.

Participant Flow:   Overall Study
    Brexpiprazole +ADT
STARTED   1036 
Lost to Follow-up                52 
Adverse Event                127 
Participant met withdrawal criteria                40 
Withdrawal by Subject                100 
Protocol deviation                83 
Lack of Efficacy                68 
Physician Decision                6 

  Baseline Characteristics

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
Brexpiprazole+ADT All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 44.0  (11.0) 
[Units: Participants]
Female   702 
Male   334 

  Outcome Measures

1.  Primary:   Participants With Adverse Events (AEs).   [ Time Frame: After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit ]

2.  Secondary:   Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.   [ Time Frame: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF]) ]

3.  Secondary:   Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.   [ Time Frame: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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. Identifier: NCT01447576     History of Changes
Other Study ID Numbers: 331-08-212
First Submitted: September 29, 2011
First Posted: October 6, 2011
Results First Submitted: August 4, 2015
Results First Posted: November 6, 2015
Last Update Posted: November 6, 2015