Summary:
To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD).
Eligibility:
Ages Eligible for Study: 65 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
- The patient is an outpatient consulting a psychiatrist.
- The patient has a recurrent Major Depressive Disorder diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient had at least one previous MDE before the age of 60 years.
- The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressants treatments.
- The patient, if a woman, must have had her last natural menstruation ≥24 months prior to the Screening Visit.
- The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential.
Qualified Participants May Receive:
Investigational medication and all study related visits at no cost. Possible compensation for each completed visit.