Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly 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 a recurrent Major Depressive Disorder diagnosed according toDSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using theMini International Neuropsychiatric Interview (MINI).

• The patient had at least one previous MDE before the age of 60 years.

• The patient has a moderate to severe depression and an insufficient response to atleast one and no more than three adequate antidepressants treatments.

• The patient, if a woman, must have had her last natural menstruation ≥24 months priorto the Screening Visit.

• The patient, if a man, agrees to protocol-defined use of effective contraception ifhis female partner is of childbearing potential.

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 psychoticsymptomatology in the current MDE.

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

• The patient, in the opinion of the investigator, or according to Columbia SuicideSeverity 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 a neurodegenerative disorder.

• The patient has, at the Screening Visit an abnormal ECG that is, in the investigator'sopinion, clinically significant.

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

• The patient is, in the investigator's opinion, unlikely to comply with the protocol oris unsuitable for any reason. Other inclusion and exclusion criteria may apply.