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

Launched by OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC. · Nov 24, 2008

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.