Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

Inclusion Criteria

• •Have a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation.
• •Have a treatment history of an inadequate ADT response to at least 1 ADT (but not \> 3) for the current episode.
• •Have received a single, trial-approved, SSRI or SNRI at an adequate dose for
• •≥ 6 weeks prior to screening.
• •Are 18 to 65 years old at the time of consent (inclusive, and outpatients only).
• •Have a Hamilton Depression Rating Scale (HAM-D)-17-item Total Score ≥ 18 at screening and baseline.
• •Have a Hamilton Anxiety Rating Scale (HAM-A) Total Score ≥ 20 at screening and baseline.