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Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients

NCT00882518 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2012-05-15

Study results available
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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.

Conditions

Interventions

DRUG

Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

200 mg or 300 mg, oral, single dose

DRUG

Chlorpromazine

50 mg, oral, double dose

Sponsors & Collaborators

Principal Investigators

  • Niufan Gu · Shanghai Mental Health Center

  • Michael Castiglione · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00882518 on ClinicalTrials.gov