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Seroquel on Glucose Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00214578
First Posted: September 22, 2005
Last Update Posted: January 4, 2013
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.
Information provided by:
AstraZeneca
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Seroquel on Glucose Metabolism

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
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


  Show 76 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca CNS Medical Group AstraZeneca
  More Information

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 Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by AstraZeneca:
Schizophrenia

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