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

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.

Key facts

Study ID

NCT01052077

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

773

Starts

2010-03-01

Expected to finish

2011-11-01

Last updated by the study team

2015-11-02

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

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Pacific Clinical Research Medical Group — Arcadia, California, United States
• Southwestern Research — Beverly Hills, California, United States
• Excell Research — Oceanside, California, United States
• Affiliated Research Institute — San Diego, California, United States
• Neuropsychiatric Research Center of Orange County — Santa Ana, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, 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
• Scientific Clinical Research, Inc. — North Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Comprehensive NeuroScience, Inc. — Atlanta, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Goldpoint Clinical Research, LLC — Indianapolis, Indiana, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Clinical InSights — Glen Burnie, Maryland, United States
• Pharmasite Research, Inc. — Pikesville, Maryland, United States
• MSU/Institute for Health Studies — East Lansing, Michigan, United States
• Center for Emotional Fitness — Cherry Hill, New Jersey, United States
• Neurobehavioral Research, Inc. — Cedarhurst, New York, United States
• Eastside Comprehensive Medical Center — New York, New York, United States
• Medical & Behavioral Health Research, PC — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States

Full record on ClinicalTrials.gov

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