Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

Completed · Phase 3 · Has a placebo group

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

In brief

The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress

Key facts

Study ID

NCT02196506

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

837

Starts

2014-07-01

Expected to finish

2016-05-01

Last updated by the study team

2018-08-21

Who can join

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

You may qualify if…

• Male and Female subjects between 18-65 years of age, with diagnosis of major depressive disorder with or without anxious distress
• Current depressive episode must be at least 8 weeks in duration

You may not qualify if…

• Subjects with a history of Neuroleptic Malignant Syndrome or Serotonin Syndrome
• Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
• Subjects with a current Axis I diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Beverly Hills, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hialeah, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Alpharetta, Georgia, United States
• Study site — Smyrna, Georgia, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Rochester Hills, Michigan, United States
• Study site — Cherry Hill, New Jersey, United States
• Study site — Jamaica, New York, United States
• Study site — New York, New York, United States
• Study site — Staten Island, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Edmond, Oklahoma, United States
• Study site — Portland, Oregon, United States
• Study site — Salem, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Lincoln, Rhode Island, United States
• Study site — Columbia, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Wichita Falls, Texas, United States
• Study site — Murray, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.