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Seroquel on Glucose Metabolism

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 14, 2005
Last updated: January 3, 2013
Last verified: January 2013
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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00214578

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00214578     History of Changes
Other Study ID Numbers: D1441C00125
Study First Received: September 14, 2005
Last Updated: January 3, 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 processed this record on September 21, 2017