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Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial) (Orion)

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ClinicalTrials.gov Identifier: NCT01360866
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Interventions: Drug: OPC-34712
Drug: Escitalopram
Drug: Fluoxetine
Drug: Paroxetine CR
Drug: Sertraline
Drug: Duloxetine
Drug: Venlafaxine XR

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was conducted in 2944 participants at 188 sites in 11 countries: Canada, France, Germany, Hungary, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, and United States (US).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study population consisted of eligible participants who completed one of the double-blind, phase 3 brexpiprazole major depressive disorder (MDD) trials and who, could potentially benefit from adjunctive treatment with oral brexpiprazole for MDD.

Reporting Groups
  Description
Prior Placebo Participants who received placebo with antidepressant therapy [ADT] in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Prior Brexpiprazole Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Prior ADT Participants who received only ADT in previous double blind phase 3 studies and were not randomized, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Prior Seroquel Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.

Participant Flow:   Overall Study
    Prior Placebo   Prior Brexpiprazole   Prior ADT   Prior Seroquel
STARTED   516   707   1645   76 
COMPLETED   295   420   1126   54 
NOT COMPLETED   221   287   519   22 
Lost to Follow-up                11                28                41                0 
Adverse Event                56                61                134                6 
Paticipant met withdrawal criteria                11                28                54                0 
Withdrawn by Investigator                9                8                31                2 
Withdrawal by participant                79                89                168                8 
Protocol Deviation                25                33                61                2 
Lack of Efficacy                30                40                30                4 



  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.
comprised of all participants who signed an informed consent form (ICF) for the trial.

Reporting Groups
  Description
Prior Placebo Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Prior Brexpiprazole Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Prior ADT Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Prior Seroquel Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Total Total of all reporting groups

Baseline Measures
   Prior Placebo   Prior Brexpiprazole   Prior ADT   Prior Seroquel   Total 
Overall Participants Analyzed 
[Units: Participants]
 516   707   1645   76   2944 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.0  (11.0)   45.0  (11.0)   44.0  (12.0)   44.0  (11.0)   45.0  (12.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      367  71.1%      479  67.8%      1108  67.4%      51  67.1%      2005  68.1% 
Male      149  28.9%      228  32.2%      537  32.6%      25  32.9%      939  31.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
White   452   609   1459   68   2588 
Black or African American   55   76   149   8   288 
American Indian or Alaska Native   0   6   8   0   14 
Asian   5   8   8   0   21 
Native Hawaiian or Other Pacific Islander   0   0   6   0   6 
Other   4   8   15   0   27 


  Outcome Measures

1.  Primary:   Adverse Events (AEs) - All Participants   [ Time Frame: From screening to week 52/early termination ]

2.  Secondary:   Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score   [ Time Frame: From screening to week 52/early termination ]

3.  Secondary:   Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score   [ Time Frame: From screening to week 52/early termination ]

4.  Secondary:   Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score   [ Time Frame: From screening to week 52/early termination ]

5.  Secondary:   Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score   [ Time Frame: From screening to week 52/early termination ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Clinical Development
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.
phone: 609 524 6788
e-mail: clinicaltransparency@otsuka-us.com



Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01360866     History of Changes
Other Study ID Numbers: 331-10-238
First Submitted: May 24, 2011
First Posted: May 26, 2011
Results First Submitted: May 25, 2018
Results First Posted: September 17, 2018
Last Update Posted: September 17, 2018