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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797966

  Show 50 Study Locations
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
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014