Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT.

Key facts

Study ID

NCT00797966

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

850

Starts

2009-05-01

Expected to finish

2010-07-01

Last updated by the study team

2016-02-29

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 at least one and 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

• Pacific Clinical Research Medical Group — Arcadia, California, United States
• Southwestern Research — Beverly Hills, California, United States
• Synergy Escondido — Escondido, California, United States
• Collaborative Neuroscience Network Inc. — Garden Grove, California, United States
• Synergy Clinical Research Center — National City, California, United States
• Excell Research — Oceanside, California, United States
• Affiliated Research Institute — San Diego, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• Radiant Research Center — Denver, Colorado, United States
• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• CNS Clinical Research Group — Coral Springs, Florida, United States
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Accurate Clinical Trials — Kissimee, Florida, United States
• Clinical Neurosciences Solutions — Orlando, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• University of South Florida College of Medicine Psychiatry Center — Tampa, Florida, United States
• Janus Center — West Palm Beach, Florida, United States
• Carman Research — Smyrna, Georgia, United States
• Uptown Research Institute — Chicago, Illinois, United States
• Midwest Center for Neurobehavioral Medicine — Oakbrook Terrace, Illinois, United States
• The Davis Clinic, PC — Indianapolis, Indiana, United States
• Vince & Associates Clinical Research — Overland Park, Kansas, United States
• Pharmasite Research, Inc. — Baltimore, Maryland, United States
• Bioscience Research — Mount Kisco, New York, United States

Full record on ClinicalTrials.gov

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