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

November 24, 2008
May 15, 2012
May 2009
June 2010   (final data collection date for primary outcome measure)
Change in a depression rating scale [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00797966 on ClinicalTrials.gov Archive Site
Change in disability scale and Clinical Global Impression scale [ Time Frame: Week 14 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: OPC-34712
    Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks
    Other Name: Generic Name: Brexpiprazole
  • 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)
  • Experimental: 1
    OPC-34712 + ADT
    Interventions:
    • Drug: OPC-34712
    • Drug: ADT
  • Placebo Comparator: 2
    Placebo + ADT
    Interventions:
    • Drug: Placebo
    • Drug: ADT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
850
July 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00797966
331-08-211
Yes
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP