Back to resultsSeroquel on Glucose Metabolism
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Seroquel (quetiapine)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility 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
Sites / Locations
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Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00214578
Brief Title
Seroquel on Glucose Metabolism
Official Title
Seroquel on Glucose Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
572 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Seroquel (quetiapine)
Primary Outcome Measure Information:
Title
To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
Secondary Outcome Measure Information:
Title
Glucose metabolism, blood lipid levels and weight
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca CNS Medical Group
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Burgas
Country
Bulgaria
Facility Name
Research Site
City
Ruse
Country
Bulgaria
Facility Name
Research Site
City
Russe
Country
Bulgaria
Facility Name
Research Site
City
Sofia- Novi Iskar
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Dobjany
Country
Czech Republic
Facility Name
Research Site
City
Dob¿any u Plzn¿
Country
Czech Republic
Facility Name
Research Site
City
Havlí¿k¿v Brod
Country
Czech Republic
Facility Name
Research Site
City
Kladno
Country
Czech Republic
Facility Name
Research Site
City
Miro¿ov
Country
Czech Republic
Facility Name
Research Site
City
Opava
Country
Czech Republic
Facility Name
Research Site
City
Plzen
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
Country
Czech Republic
Facility Name
Research Site
City
Praha 5
Country
Czech Republic
Facility Name
Research Site
City
Praha 6
Country
Czech Republic
Facility Name
Research Site
City
Praha 8
Country
Czech Republic
Facility Name
Research Site
City
Tübingen
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Research Site
City
München
State/Province
Bayern
Country
Germany
Facility Name
Research Site
City
Bonn
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Research Site
City
Düsseldorf
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Research Site
City
Münster
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Research Site
City
Magdeburg
State/Province
Sachsen-Anhalt
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Bonn
Country
Germany
Facility Name
Research Site
City
Düsseldorf
Country
Germany
Facility Name
Research Site
City
Herten
Country
Germany
Facility Name
Research Site
City
Magdeburg
Country
Germany
Facility Name
Research Site
City
München
Country
Germany
Facility Name
Research Site
City
Tübingen
Country
Germany
Facility Name
Research Site
City
Balassagyarmat
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Cegléd
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Eger
Country
Hungary
Facility Name
Research Site
City
Gy¿r
Country
Hungary
Facility Name
Research Site
City
Kaposvár
Country
Hungary
Facility Name
Research Site
City
Kecskemét
Country
Hungary
Facility Name
Research Site
City
Szeged
Country
Hungary
Facility Name
Research Site
City
Szolnok
Country
Hungary
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Drammen
Country
Norway
Facility Name
Research Site
City
Hagavik
Country
Norway
Facility Name
Research Site
City
Stavanger
Country
Norway
Facility Name
Research Site
City
Stokmarknes
Country
Norway
Facility Name
Research Site
City
Straume
Country
Norway
Facility Name
Research Site
City
Tønsberg
Country
Norway
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Banská Bystrica
Country
Slovakia
Facility Name
Research Site
City
Bojnice
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Hronovce
Country
Slovakia
Facility Name
Research Site
City
Ko¿ice
Country
Slovakia
Facility Name
Research Site
City
Liptovský Mikulá¿
Country
Slovakia
Facility Name
Research Site
City
Michalovce Strá¿any
Country
Slovakia
Facility Name
Research Site
City
Nitra
Country
Slovakia
Facility Name
Research Site
City
Pre¿ov
Country
Slovakia
Facility Name
Research Site
City
Rimavská Sobota
Country
Slovakia
Facility Name
Research Site
City
¿ilina-Byt¿ica
Country
Slovakia
Facility Name
Research Site
City
¿ilina
Country
Slovakia
Facility Name
Research Site
City
Medunsa
State/Province
Pretoria
Country
South Africa
Facility Name
Research Site
City
Bloemfontein
Country
South Africa
Facility Name
Research Site
City
CapeTown
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Ga-Rankuwa
Country
South Africa
Facility Name
Research Site
City
Johannesburg
Country
South Africa
Facility Name
Research Site
City
Krugersdorp
Country
South Africa
Facility Name
Research Site
City
Parktown
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Tygerberg
Country
South Africa
Facility Name
Research Site
City
Sutton Coldfield
State/Province
West Midlands
Country
United Kingdom
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19358783
Citation
Newcomer JW, Ratner RE, Eriksson JW, Emsley R, Meulien D, Miller F, Leonova-Edlund J, Leong RW, Brecher M. A 24-week, multicenter, open-label, randomized study to compare changes in glucose metabolism in patients with schizophrenia receiving treatment with olanzapine, quetiapine, or risperidone. J Clin Psychiatry. 2009 Apr;70(4):487-99. doi: 10.4088/jcp.08m04132. Epub 2009 Apr 7.
Results Reference
derived
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Seroquel on Glucose Metabolism
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