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Seroquel vs Risperidone in Chinese Han Patients with Schizophrenia

NCT00817648Phase 4

Key facts

Status: Completed
Start: Dec 2008
Primary completion: May 2010
Countries: 1
Sponsor: Shanghai Mental Health Center
Modality: Small Molecules

Drugs: quetiapine (extended-release tablet, brand name: Bipresso)
Conditions: schizophrenia

Overview

Phase 4, randomised, single-blind trial of quetiapine (extended-release tablet, brand name: Bipresso) in schizophrenia (2 arms), sponsored by Shanghai Mental Health Center. Primary endpoint: Change in Positive and Negative Syndrome Scale Total Score at 6 weeks. Started Dec 2008; status: completed.

Design

2 arms

Study design: RandomizedSingle-blind

Quetiapine
Quetiapine fumarate, flexible doses (600-750 mg/d)
Risperidone
Risperidone, flexible doses (3-6 mg/d)

Who it enrols

Chinese Han patients aged 18-65 with acute schizophrenia (PANSS >= 70). Excludes patients with diabetes mellitus, imminent suicide risk, or substance dependence.

Endpoints

Primary

Change in Positive and Negative Syndrome Scale Total Score6 weeks

Secondary

Calgary Depression Scale for Schizophrenia6 weeks
Abnormal Involuntary Movement Scale6 weeks
Simpson and Angus Scale6 weeks
Clinical Global Impression6 weeks

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