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

NCT ID: NCT00797966

Last Updated: 2016-02-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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A comparison of the Fixed dose arm (OPC-31712, 0.15 mg) verses placebo was included as a general secondary efficacy variable and results for this dose group comparison are included under each of the Outcome Measures.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

OPC-34712 + ADT

Group Type EXPERIMENTAL

OPC-34712

Intervention Type DRUG

Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks

ADT

Intervention Type DRUG

Tablets, 10 - 225 mgs, dose once daily, 14 weeks

2

Placebo + ADT

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks

ADT

Intervention Type DRUG

Tablets, 10 - 225 mgs, dose once daily, 14 weeks

Interventions

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OPC-34712

Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks

Intervention Type DRUG

Placebo

Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks

Intervention Type DRUG

ADT

Tablets, 10 - 225 mgs, dose once daily, 14 weeks

Intervention Type DRUG

Other Intervention Names

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Generic Name: Brexpiprazole 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 Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pacific Clinical Research Medical Group

Arcadia, California, United States

Site Status

Southwestern Research

Beverly Hills, California, United States

Site Status

Synergy Escondido

Escondido, California, United States

Site Status

Collaborative Neuroscience Network Inc.

Garden Grove, California, United States

Site Status

Synergy Clinical Research Center

National City, California, United States

Site Status

Excell Research

Oceanside, California, United States

Site Status

Affiliated Research Institute

San Diego, California, United States

Site Status

California Neuroscience Research Medical Group, Inc.

Sherman Oaks, California, United States

Site Status

Radiant Research Center

Denver, Colorado, United States

Site Status

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

Site Status

CNS Clinical Research Group

Coral Springs, Florida, United States

Site Status

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Site Status

Accurate Clinical Trials

Kissimee, Florida, United States

Site Status

Clinical Neurosciences Solutions

Orlando, Florida, United States

Site Status

Stedman Clinical Trials

Tampa, Florida, United States

Site Status

University of South Florida College of Medicine Psychiatry Center

Tampa, Florida, United States

Site Status

Janus Center

West Palm Beach, Florida, United States

Site Status

Carman Research

Smyrna, Georgia, United States

Site Status

Uptown Research Institute

Chicago, Illinois, United States

Site Status

Midwest Center for Neurobehavioral Medicine

Oakbrook Terrace, Illinois, United States

Site Status

The Davis Clinic, PC

Indianapolis, Indiana, United States

Site Status

Vince & Associates Clinical Research

Overland Park, Kansas, United States

Site Status

Pharmasite Research, Inc.

Baltimore, Maryland, United States

Site Status

Bioscience Research

Mount Kisco, New York, United States

Site Status

Eastside Comprehensive Medical Center

New York, New York, United States

Site Status

Medical & Behavioral Health Research, PC

New York, New York, United States

Site Status

Finger Lakes Clinical Research

Rochester, New York, United States

Site Status

Carolinas HealthCare - Behavioral Heath Center

Charlotte, North Carolina, United States

Site Status

NorthCoast Clinical Trials, Inc

Beachwood, Ohio, United States

Site Status

Neuro-Behavioral Clinical Research, Inc

Canton, Ohio, United States

Site Status

Patient Priority Clinical Sites, LLC

Cinncinnati, Ohio, United States

Site Status

Midwest Clinical Research Center

Dayton, Ohio, United States

Site Status

NorthStar Medical Research, LLC

Middleburg Heights, Ohio, United States

Site Status

Summitt Research Network (Oregon)

Portland, Oregon, United States

Site Status

Suburban Research Associates

Media, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

USC School of Medicine- Department of Neuropsychiatry and Behavioral Science

Columbia, South Carolina, United States

Site Status

Clinical Neurosciences Solutions, Inc.

Memphis, Tennessee, United States

Site Status

Community Clinical Research, Inc.

Austin, Texas, United States

Site Status

FutureSearch Clinical Trials

Austin, Texas, United States

Site Status

Radiant Research

Salt Lake City, Utah, United States

Site Status

Mood Disorders Clinic

Salt Lake City, Utah, United States

Site Status

Psychiatric Alliance of the Blue Ridge

Charlottesville, Virginia, United States

Site Status

NeuroScience, Inc.

Herndon, Virginia, United States

Site Status

Dominion Clinical Research

Midlothian, Virginia, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Summit Research Network (Seattle) LLC

Seattle, Washington, United States

Site Status

Northbrooke Research Center

Brown Deer, Wisconsin, United States

Site Status

Dean Foundation

Middleton, Wisconsin, United States

Site Status

Countries

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United States

References

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Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.

Reference Type DERIVED
PMID: 30508090 (View on PubMed)

Other Identifiers

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331-08-211

Identifier Type: -

Identifier Source: org_study_id

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