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Seroquel on Glucose Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00214578
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 4, 2013
Sponsor:
Information provided by:
AstraZeneca

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
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
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Outcome Measures
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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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca CNS Medical Group AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00214578    
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:
Schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
 Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs