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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01360866
First received: May 24, 2011
Last updated: January 25, 2017
Last verified: January 2017
  Purpose
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 Depression Depressive Disorder, Major Mood Disorders Mental Disorders Drug: OPC-34712 + ADT Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 26 ]
    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 26 ]
    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: May 2017
Estimated Primary Completion Date: April 2017 (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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01360866

  Show 83 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01360866     History of Changes
Other Study ID Numbers: 331-10-238
Study First Received: May 24, 2011
Last Updated: January 25, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
OPC-34712
brexpiprazole
Major Depressive Disorder
Adjunctive Treatment

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Psychotic Disorders
Pathologic Processes
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders

ClinicalTrials.gov processed this record on September 19, 2017