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Seroquel on Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT00214578
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 4, 2013
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: Seroquel (quetiapine) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 572 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Seroquel on Glucose Metabolism
Study Start Date : April 2004
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Primary Outcome Measures :
  1. To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients

Secondary Outcome Measures :
  1. Glucose metabolism, blood lipid levels and weight

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214578

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Sponsors and Collaborators
Study Director: AstraZeneca CNS Medical Group AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00214578     History of Changes
Other Study ID Numbers: D1441C00125
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs