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

Main 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.

Main Exclusion Criteria:

Subjects with any of the following current Axis I DSM-IV-TR diagnoses:

• delirium
• dementia
• amnestic
• other cognitive disorders
• schizophrenia
• schizoaffective disorder
• other psychotic disorders
• bipolar I disorder,
• bipolar II disorder
• bipolar disorder not otherwise specified (NOS)
• eating disorders
• anorexia nervosa
• bulimia
• obsessive compulsive disorder
• post-traumatic stress disorder

Subjects with any of the following current Axis II DSM-IV-TR diagnoses:

• borderline, antisocial
• paranoid
• schizoid
• schizotypal
• histrionic personality disorders
• mental retardation.