Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: May 24, 2011
Last updated: August 4, 2014
Last verified: August 2014

To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)

Condition Intervention Phase
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Drug: OPC-34712 + ADT
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Primary Outcome Measures [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Assess the safety and tolerability of OPC-34712 by examining the frequency and severity of adverse events

Secondary Outcome Measures:
  • Secondary Outcome Measures [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Change from baseline in Sheehan Disability Scale (SDS), Inventory of Depressive Symptomatology (IDS-SR), and Clinical Global Impression - Severity of Illness (CGI-S) scales

Estimated Enrollment: 3000
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: OPC-34712 + ADT
Drug: OPC-34712 + ADT
Tablets, Oral, 0.5 - 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and Female outpatients 18-65 years of age

Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:

  • Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or
  • Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial

Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:

• Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.

Exclusion Criteria:

  • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-34712.
  • Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01360866

  Show 90 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT01360866     History of Changes
Other Study ID Numbers: 331-10-238
Study First Received: May 24, 2011
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Ministry of Health
Canada: Health Canada
Russia: Pharmacological Committee, Ministry of Health
Romania: Ministry of Public Health
Ukraine: Ministry of Health
Slovakia: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Major Depressive Disorder
Adjunctive Treatment

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes processed this record on February 27, 2015