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

NCT01360866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2944

Last updated 2018-09-17

Study results available
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Summary

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)

Conditions

  • Depressive Disorder
  • Depression
  • Depressive Disorder, Major
  • Mood Disorders
  • Mental Disorders

Interventions

DRUG

OPC-34712

Tablet

DRUG

Escitalopram

Tablet

DRUG

Fluoxetine

Capsule

DRUG

Paroxetine CR

Controlled-release tablets

DRUG

Sertraline

Tablets

DRUG

Duloxetine

Delayed-release capsules

DRUG

Venlafaxine XR

Extended-release capsules

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-04-18
Completion
2017-05-18

Countries

  • United States
  • Canada
  • France
  • Germany
  • Hungary
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01360866 on ClinicalTrials.gov