Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder

Inclusion Criteria:

• The patient is judged to benefit from adjunctive treatment with brexpiprazoleaccording to the clinical opinion of the investigator.

• The patient had MDD at entry in lead-in brexpiprazole studies, NCT01838681 / 14570A orNCT01837797 / 14571A, diagnosed according to DSM-IV-TR™.

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

Exclusion Criteria:

• The patient has a disease or takes medication that could, in the investigator'sopinion, interfere with the assessments of safety, tolerability, or efficacy, orinterfere with the conduct or interpretation of the study.

• The patient has been diagnosed with a psychiatric disorder other than MDD during thelead-in studies NCT01838681 / 14570A or NCT01837797 / 14571A.

• The patient, in the opinion of the investigator or according to C-SSRS, is atsignificant risk of suicide.

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

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

• The patient has a moderate or severe ongoing adverse event related to study medicationfrom the lead-in studies considered of potential safety risk by the investigator.

• 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.