Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder

Completed · Phase 2

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).

Key facts

Study ID

NCT01447576

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

1036

Starts

2009-09-01

Expected to finish

2012-12-01

Last updated by the study team

2015-11-06

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 a diagnosis of a single or recurrent, non-psychotic episode of major depressive disorder, as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) which is equal to or greater than 8 weeks in duration.
• Subjects must currently be taking allowable antidepressant therapy at an adequate dose for a minimum of six weeks by the end of the screening period (ie at the time of the Baseline visit).
• Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than four 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, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic stress 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
• Artemis Institute for Clinical Research — San Diego, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
• Clinical Neuroscience Solutions — Jacksonville, Florida, United States
• Florida Clinical Research Center — Maitland, Florida, United States
• Clinical Neurosciences Solutions — Orlando, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• Carman Research — Smyrna, Georgia, United States
• Goldpoint Clinical Research, LLC — Indianapolis, Indiana, United States
• Pharmasite Research — Baltimore, Maryland, United States
• Clinical Insights — Glen Burnie, Maryland, United States
• Rochester Center for Behavioral Medicine — Rochester Hills, Michigan, United States
• Center for Psychiatry and Behavioral Medicine, Inc. — Las Vegas, Nevada, United States
• Center for Emotional Fitness — Cherry Hill, New Jersey, United States
• Brooklyn Medical Institute — Brooklyn, New York, United States
• Medical & Behavioral Health Research — New York, New York, United States
• The Medical Research Network, LLC — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Oregon Center for Clinical Investigations, Inc. — Portland, Oregon, United States
• Oregon Center for Clinical Investigations — Salem, Oregon, United States
• Carolina Clinical Research Services — Columbia, South Carolina, United States
• FutureSearch Trials of Dallas — Dallas, Texas, United States
• Bayou City Research, Ltd. — Houston, Texas, United States

Full record on ClinicalTrials.gov

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