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 bythe Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, TextRevision (DSM-IV-TR) and confirmed by both the Mini International NeuropsychiatricInterview (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 screeningand baseline.

• Have a Hamilton Anxiety Rating Scale (HAM-A) Total Score ≥ 20 at screening andbaseline.

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.