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

Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Escitalopram (Drug); Fluoxetine (Drug); Paroxetine CR (Drug); Sertraline (Drug); Citalopram Hydrobromide (Drug); Desvenlafaxine (Drug); Venlafaxine XR (Drug); Duloxetine Hydrochloride (Drug); Bupropion (Drug); OPC-34712 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Summary

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).

Clinical Details

Official title: A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adult Patients With Major Depressive Disorder

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary outcome variable is the safety and tolerability of OPC-34712 which will be assessed by examining the frequency and severity of adverse events (AEs).

Secondary outcome:

The secondary efficacy variables will be as follows: change from baseline in Clinical Global Impression - Severity of Illness scale score.

The secondary efficacy variables will be as follows: change from baseline in the mean Clinical Global Impression - Improvement scale score.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- 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.

Locations and Contacts

Pacific Clinical Research Medical Group, Arcadia, California 91007, United States

Artemis Institute for Clinical Research, San Diego, California 92123, United States

California Neuroscience Research Medical Group, Inc., Sherman Oaks, California 91403, United States

Gulfcoast Clinical Research Center, Fort Myers, Florida 33912, United States

Clinical Neuroscience Solutions, Jacksonville, Florida 32216, United States

Florida Clinical Research Center, Maitland, Florida 32751, United States

Clinical Neurosciences Solutions, Orlando, Florida 32806, United States

Stedman Clinical Trials, Tampa, Florida 33613, United States

Carman Research, Smyrna, Georgia 30080, United States

Goldpoint Clinical Research, LLC, Indianapolis, Indiana 46240, United States

Pharmasite Research, Baltimore, Maryland 91208, United States

Clinical Insights, Glen Burnie, Maryland 21061, United States

Rochester Center for Behavioral Medicine, Rochester Hills, Michigan 48307, United States

Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada 89128, United States

Center for Emotional Fitness, Cherry Hill, New Jersey 08002, United States

Brooklyn Medical Institute, Brooklyn, New York 11214, United States

Medical & Behavioral Health Research, New York, New York 10023, United States

The Medical Research Network, LLC, New York, New York 10128, United States

Finger Lakes Clinical Research, Rochester, New York 14618, United States

Midwest Clinical Research Center, Dayton, Ohio 45417, United States

Oregon Center for Clinical Investigations, Inc., Portland, Oregon 97210, United States

Oregon Center for Clinical Investigations, Salem, Oregon 97301, United States

Carolina Clinical Research Services, Columbia, South Carolina 29201, United States

FutureSearch Trials of Dallas, Dallas, Texas 75231, United States

Bayou City Research, Ltd., Houston, Texas 77007, United States

Radiant Research, Murray, Utah 84123, United States

Psychiatric Alliance of the Blue Ridge, Charlottesville, Virginia 22903, United States

Neuroscience, Inc., Herndon, Virginia 20170, United States

Northwest Clinical Research Center, Bellevue, Washington 98007, United States

Summit Research Network, Seattle, Washington 98104, United States

Northbrooke Research Center, Brown Deer, Wisconsin 53223, United States

Dean Foundation, Middleton, Wisconsin 53562, United States

Additional Information

Starting date: September 2009
Last updated: April 11, 2014

Page last updated: August 23, 2015

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