Seroquel on Glucose Metabolism - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00214578

Purpose

The purpose of this study is to determine whether six months treatment with the antipsychotic medicine Seroquel (quetiapine) may affect the schizophrenic patient's glucose metabolism

Condition	Intervention	Phase
Schizophrenia	Drug: Seroquel (quetiapine)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Seroquel on Glucose Metabolism

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:

To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients

Secondary Outcome Measures:

Glucose metabolism, blood lipid levels and weight

Estimated Enrollment:	572
Study Start Date:	April 2004
Study Completion Date:	October 2005

Eligibility

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

Criteria

Inclusion Criteria:

In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.

Exclusion Criteria:

Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT.
Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
Contraindications or non-responsiveness for any of the treatments or other safety issues
Expected non-compliance to treatment and/or study procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214578

Show 77 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca CNS Medical Group

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Newcomer JW, Ratner RE, Eriksson JW, Emsley R, Meulien D, Miller F, Leonova-Edlund J, Leong RW, Brecher M. A 24-week, multicenter, open-label, randomized study to compare changes in glucose metabolism in patients with schizophrenia receiving treatment with olanzapine, quetiapine, or risperidone. J Clin Psychiatry. 2009 Apr;70(4):487-99. Epub 2009 Apr 7.

Study ID Numbers:	D1441C00125
Study First Received:	September 14, 2005
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00214578 History of Changes
Health Authority:	United States: Food and Drug Administration; Bulgaria: Bulgarian Drug Agency; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Norway: Norwegian Medicines Agency; Romania: State Institute for Drug Control; South Africa: Medicines Control Council; Slovakia: State Institute for Drug Control

Keywords provided by AstraZeneca:

Schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010