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.