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Seroquel on Glucose Metabolism

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00214578
First received: September 14, 2005
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Seroquel on Glucose Metabolism

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
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 76 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 ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00214578     History of Changes
Other Study ID Numbers: D1441C00125
Study First Received: September 14, 2005
Last Updated: January 3, 2013
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
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013