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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00797966
First received: November 24, 2008
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: OPC-34712
Drug: Placebo
Drug: ADT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Change in a depression rating scale [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in disability scale and Clinical Global Impression scale [ Time Frame: Week 14 ] [ Designated as safety issue: Yes ]

Enrollment: 850
Study Start Date: May 2009
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
OPC-34712 + ADT
Drug: OPC-34712
Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks
Other Name: Generic Name: Brexpiprazole
Drug: ADT
Tablets, 10 - 225 mgs, dose once daily, 14 weeks
Other Names:
  • Each individual will receive one of the following 6 ADTs:
  • Escitalopram (Lexapro)
  • Fluoxetine (Prozac)
  • Paroxetine CR (Paxil CR)
  • Sertraline (Zoloft)
  • Desvenlafaxine (Pristiq)
  • Venalfaxine XR (Effexor XR)
Placebo Comparator: 2
Placebo + ADT
Drug: Placebo
Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks
Drug: ADT
Tablets, 10 - 225 mgs, dose once daily, 14 weeks
Other Names:
  • Each individual will receive one of the following 6 ADTs:
  • Escitalopram (Lexapro)
  • Fluoxetine (Prozac)
  • Paroxetine CR (Paxil CR)
  • Sertraline (Zoloft)
  • Desvenlafaxine (Pristiq)
  • Venalfaxine XR (Effexor XR)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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
    • Subjects with a clinically significant current Axis II (DSM-IV-TR)
    • diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797966

  Hide Study Locations
Locations
United States, California
Pacific Clinical Research Medical Group
Arcadia, California, United States, 91007
Southwestern Research
Beverly Hills, California, United States, 90210
Synergy Escondido
Escondido, California, United States, 92025
Collaborative Neuroscience Network Inc.
Garden Grove, California, United States, 92845
Synergy Clinical Research Center
National City, California, United States, 91950
Excell Research
Oceanside, California, United States, 92056
Affiliated Research Institute
San Diego, California, United States, 92108
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States, 91403
United States, Colorado
Radiant Research Center
Denver, Colorado, United States, 80239
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34208
CNS Clinical Research Group
Coral Springs, Florida, United States, 33065
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States, 33912
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32216
Accurate Clinical Trials
Kissimee, Florida, United States, 34741
Clinical Neurosciences Solutions
Orlando, Florida, United States, 32806
University of South Florida College of Medicine Psychiatry Center
Tampa, Florida, United States, 33613
Stedman Clinical Trials
Tampa, Florida, United States, 33613
Janus Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
Carman Research
Smyrna, Georgia, United States, 30080
United States, Illinois
Uptown Research Institute
Chicago, Illinois, United States, 60640
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, United States, 60181
United States, Indiana
The Davis Clinic, PC
Indianapolis, Indiana, United States, 46260
United States, Kansas
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Maryland
Pharmasite Research, Inc.
Baltimore, Maryland, United States, 21208
United States, New York
Bioscience Research
Mount Kisco, New York, United States, 10549
Medical & Behavioral Health Research, PC
New York, New York, United States, 10023
Eastside Comprehensive Medical Center
New York City, New York, United States, 10021
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, North Carolina
Carolinas HealthCare - Behavioral Heath Center
Charlotte, North Carolina, United States, 28211
United States, Ohio
NorthCoast Clinical Trials, Inc
Beachwood, Ohio, United States, 44122
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, United States, 44718
Patient Priority Clinical Sites, LLC
Cinncinnati, Ohio, United States, 45242
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
NorthStar Medical Research, LLC
Middleburg Heights, Ohio, United States, 44130
United States, Oregon
Summitt Research Network (Oregon)
Portland, Oregon, United States, 97210
United States, Pennsylvania
Suburban Research Associates
Media, Pennsylvania, United States, 19063
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
USC School of Medicine- Department of Neuropsychiatry and Behavioral Science
Columbia, South Carolina, United States, 29203
United States, Tennessee
Clinical Neurosciences Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
Community Clinical Research, Inc.
Austin, Texas, United States, 78754
FutureSearch Clinical Trials
Austin, Texas, United States, 78756
United States, Utah
Radiant Research
Salt Lake City, Utah, United States, 84107
Mood Disorders Clinic
Salt Lake City, Utah, United States, 84132
United States, Virginia
Psychiatric Alliance of the Blue Ridge
Charlottesville, Virginia, United States, 22903
NeuroScience, Inc.
Herndon, Virginia, United States, 20170
Dominion Clinical Research
Midlothian, Virginia, United States, 23112
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
United States, Wisconsin
Northbrooke Research Center
Brown Deer, Wisconsin, United States, 53223
Dean Foundation
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00797966     History of Changes
Other Study ID Numbers: 331-08-211
Study First Received: November 24, 2008
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
OPC-34712, Major Depressive Disorder, Adjunctive Treatment

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
O-desmethylvenlafaxine
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014