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

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