Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

Inclusion Criteria:

- The patient is an outpatient consulting a psychiatrist.

- The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major
Depressive Episode (MDE) should be confirmed using the Mini International
Neuropsychiatric Interview (MINI).

- The patient has a moderate to severe depression and an insufficient response to at
least one and no more than three adequate antidepressant treatments.

- The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

- The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™
criteria), established as the primary diagnosis, other than MDD.

- The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial,
paranoid, schizoid, schizotypical or histrionic personality disorder.

- The patient has experienced/experiences hallucinations, delusions or any psychotic
symptomatology in the current MDE.

- The patient suffers from mental retardation, organic mental disorders, or mental
disorders due to a general medical condition (DSM-IV-TR™ criteria).

- The patient, in the opinion of the investigator or according to Columbia-Suicide
Severity Rating Scale (C-SSRS), is at significant risk of suicide.

- The patient has had neuroleptic malignant syndrome.

- The patient has any relevant medical history or current presence of systemic disease.

- The patient has, at the Screening Visit an abnormal ECG that is, in the
investigator's opinion, clinically significant.

- The patient has a history of cancer, other than basal cell or Stage 1 squamous cell
carcinoma of the skin, that has not been in remission for >5 years prior to the first
dose of IMP.

- The patient is, in the investigator's opinion, unlikely to comply with the protocol
or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.