Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)

Completed · Phase 3 · Has a placebo group

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

In brief

To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT

Key facts

Study ID

NCT01360632

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

1539

Starts

2011-06-01

Expected to finish

2013-09-01

Last updated by the study team

2016-01-01

Who can join

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

You may qualify if…

• Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
• The current depressive episode must be equal to or greater than 8 weeks in duration
• Subjects must report a history for the current depressive episode of an inadequate response to no more than three adequate antidepressant treatments

You may not qualify if…

• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
• Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration
• Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
• Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder

Where it is running

• Research Site — Costa Mesa, California, United States
• Research Site — Glendale, California, United States
• Research Site — Orange, California, United States
• Research Site — San Diego, California, United States
• Research Site — Temecula, California, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Jacksonville Beach, Florida, United States
• Research Site — Miami Springs, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Smyrna, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Oak Brook, Illinois, United States
• Research Site — Lafayette, Indiana, United States
• Research Site — Owensboro, Kentucky, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Haverhill, Massachusetts, United States
• Research Site — Weymouth, Massachusetts, United States
• Research Site — Rochester Hills, Michigan, United States
• Research Site — Creve Coeur, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Cherry Hill, New Jersey, United States
• Research Site — Toms River, New Jersey, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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