Conditions: Major Depressive Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: no

Brief summary:
To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)

Detailed description:
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.

Arms:
arm 1: Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)

Interventions: intervention 1: Brexpiprazole
Intervention descriptions: intervention 1: 1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients ≥65) or 1 mg/day (patients 18-64 years)

Protocol document: