Conditions: Sleep Disturbances
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 44
Healthy volunteers: no

Brief summary:
To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep disturbances.

Detailed description:

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

Interventions: intervention 1: Brexpiprazole
Intervention descriptions: intervention 1: 2-3 mg/day, once daily, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgment.

Protocol document: