Conditions: Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 468
Healthy volunteers: no

Brief summary:
To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

Detailed description:

Arms:
arm 1: None arm 2: Patients randomised to brexpiprazole received 1mg/day on Day 1, 2mg/day on Day 2, 3mg/day on Day 3 (uptitration); the dose could be adjusted from Day 4 onwards to 2, 3, or 4mg/day to optimise the clinical effect and tolerability. arm 3: Active Reference. Patients randomised to quetiapine received 300mg/day on Day 1, 600mg/day on Days 2 and 3 (uptitration); the dose could be adjusted from Day 4 onwards to 400, 600, or 800mg/day to optimise the clinical effect and tolerability.

Interventions: intervention 1: Placebo intervention 2: Brexpiprazole intervention 3: Quetiapine extended release
Intervention descriptions: intervention 1: Once daily as tablets and capsules, orally intervention 2: 2-4 mg/day, once daily, tablets, orally intervention 3: 400-800 mg/day, once daily, encapsulated tablets, orally

Protocol document: