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

This study has been completed.

First Received on June 16, 2004. Last Updated on March 24, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00085891

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Quetiapine Fumarate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	535
Study Start Date:	June 2004
Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085891

Show 29 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Seroquel Medical Science Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00085891 History of Changes
Other Study ID Numbers:	D1444C00133
Study First Received:	June 16, 2004
Last Updated:	March 24, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Schizophrenia
Schizophrenic disorder

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012