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

Interventional, Open-label, Long-term Extension Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder

To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)

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.