Status:
COMPLETED
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 O...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT00797966
Start Date
May 1 2009
End Date
July 1 2010
Last Update
February 29 2016
Active Locations (50)
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1
Pacific Clinical Research Medical Group
Arcadia, California, United States, 91007
2
Southwestern Research
Beverly Hills, California, United States, 90210
3
Synergy Escondido
Escondido, California, United States, 92025
4
Collaborative Neuroscience Network Inc.
Garden Grove, California, United States, 92845