Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00085891
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-06-16
• Study First Submitted QC: 2004-06-17
• Study First Posted: 2004-06-18
• Study Completion: 2005-09
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

Inclusion Criteria

• Patient is able to provide written informed consent before beginning any study related procedures
• Patient has a documented clinical diagnosis of schizophrenia
• Patient is able to understand and comply with the requirements of the study, as judged by a study investigator

Exclusion Criteria

• Patients with a history of non-compliance as judged by the study investigator
• Patients with a known lack of response to previous treatment with quetiapine
• Patients who have participated in another drug study within 4 weeks prior to enrollment into this study
• Patients who have previously participated in this study or study D1444C00132

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.

Secondary Outcome Measures

Name	Time	Method
Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Kirkland, Washington, United States