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