Conditions: Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 129
Healthy volunteers: no

Brief summary:
To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)

Detailed description:

Arms:
arm 1: Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT) arm 2: Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week followed by 1 mg/day. arm 3: Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week, 1 mg/day in the second week, followed by 3 mg/day.

Interventions: intervention 1: Placebo intervention 2: Brexpiprazole 1 mg intervention 3: Brexpiprazole 3 mg
Intervention descriptions: intervention 1: Once daily, tablets, orally intervention 2: once daily dose, tablets, orally intervention 3: once daily dose, tablets, orally

Protocol document: