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

Completed · Phase 3

Conditions studied: Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders

In brief

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)

Key facts

Study ID

NCT01360866

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

2944

Starts

2011-10-01

Expected to finish

2017-05-18

Last updated by the study team

2018-09-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Costa Mesa, California, United States
• Research Site — Glendale, California, United States
• Research Site — Irvine, California, United States
• Research Site — Oceanside, California, United States
• Research Site — Redlands, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Sherman Oaks, California, United States
• Research Site — Temecula, California, United States
• Research Site — Upland, California, United States
• Research Site — Norwalk, Connecticut, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Coral Springs, Florida, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Jacksonville Beach, Florida, United States
• Research Site — Melbourne, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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