Conditions: Schizophrenia
Keywords: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) qualified PANSS assessment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 388
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.

Detailed description:

Arms:
arm 1: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day) arm 2: Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days)

Interventions: intervention 1: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) intervention 2: Chlorpromazine
Intervention descriptions: intervention 1: 200 mg or 300 mg, oral, single dose intervention 2: 50 mg, oral, double dose

Protocol document: