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

NCT ID: NCT00085891

Last Updated: 2009-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-09-30

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Quetiapine Fumarate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Birmingham, Alabama, United States

Site Status

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Cerritos, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Washington D.C., District of Columbia, United States

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Miami, Florida, United States

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Oak Brook, Illinois, United States

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Oakbrook Terrace, Illinois, United States

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New Orleans, Louisiana, United States

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Rockville, Maryland, United States

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Brighton, Massachusetts, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Holliswood, New York, United States

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Lawrence, New York, United States

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Staten Island, New York, United States

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Medina, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Kirkland, Washington, United States

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Countries

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United States

Other Identifiers

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D1444C00133

Identifier Type: -

Identifier Source: org_study_id

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