Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment

Main Inclusion Criteria:

- • The patient is a man or woman aged ≥65 yrs

- The patient has Major Depressive Disorder according to Diagnostic and
Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™).

- The patient has an inadequate response to at least one adequate antidepressant
treatment in the current Major Depressive Episode (MDE).

- The patient has had the current MDE for ≥8 weeks

- The patient is currently treated with a protocol specified ADT for at least 6
weeks

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

- Montgomery and Åsberg Depression Rating Scale (MADRS) total score > 18 at
screening and baseline

- Clinical Global Impression - Severity (CGI-S) total score ≥3 at screening and
baseline

Main Exclusion Criteria:

- • The patient has a clinically significant unstable illness

- The patient has newly diagnosed or unstable diabetes

- The patient has a Mini Mental State Exam (MMSE) score <24

- The patient has received Transcranial Magnetic Stimulation (TMS) and/or
electroconvulsive therapy (ECT) less than 6 months prior to the Screening.

- The patient, in the opinion of the investigator or based on Columbia-Suicide
Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at
significant risk of suicide

Other protocol defined inclusion and exclusion criteria may apply