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

This extension safety study was terminated early because one of the lead-in studies (14571A)
in elderly was terminated and because the Sponsor considered that sufficient long-term safety
data has already been collected in the development programme in the population aged 18-65
yrs.

Inclusion Criteria:

- The patient is judged to benefit from adjunctive treatment with brexpiprazole
according to the clinical opinion of the investigator.

- The patient had MDD at entry in lead-in brexpiprazole studies, NCT01838681 / 14570A or
NCT01837797 / 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's
opinion, interfere with the assessments of safety, tolerability, or efficacy, or
interfere with the conduct or interpretation of the study.

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

- The patient, in the opinion of the investigator or according to C-SSRS, is at
significant 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's
opinion, clinically significant.

- The patient has a moderate or severe ongoing adverse event related to study medication
from 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 or
is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.