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

Condition(s) targeted: Schizophrenia

Intervention: Quetiapine Fumarate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.

Secondary outcome: Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Research Site, Birmingham, Alabama, United States

Research Site, Cerritos, California, United States

Research Site, San Diego, California, United States

Research Site, Santa Ana, California, United States

Los Angeles, California, United States

Research Site, Washington, District of Columbia, United States

Research Site, Miami, Florida, United States

Research Site, Oakbrook Terrace, Illinois, United States

Oak Brook, Illinois, United States

Research Site, New Orleans, Louisiana, United States

Research Site, Rockville, Maryland, United States

Brighton, Massachusetts, United States

Research Site, Jackson, Mississippi, United States

Research Site, St. Louis, Missouri, United States

Research Site, Holliswood, New York, United States

Research Site, Lawrence, New York, United States

Research Site, Staten Island, New York, United States

Research Site, Medina, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Norristown, Pennsylvania, United States

Research Site, Sioux Falls, South Dakota, United States

Research Site, Memphis, Tennessee, United States

Research Site, Austin, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Irving, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Richmond, Virginia, United States

Research Site, Kirkland, Washington, United States

Starting date: June 2004
Last updated: February 14, 2006