Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
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Keep this study
Lead
Otsuka Pharmaceutical Development & Commercialization, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 no more than three adequate antidepressant treatments
You may not be if
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
Clareo Health | Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
