Seroquel on Glucose Metabolism
1 other identifier
interventional
572
9 countries
70
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Apr 2004
Shorter than P25 for phase_4 schizophrenia
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedJanuary 4, 2013
January 1, 2013
September 14, 2005
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
Secondary Outcomes (1)
Glucose metabolism, blood lipid levels and weight
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (70)
Research Site
Burgas, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Sofia- Novi Iskar, Bulgaria
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Varna, Bulgaria
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Dobjany, Czechia
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Dob¿any U Plzn¿, Czechia
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Havlí¿k¿v Brod, Czechia
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Kladno, Czechia
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Miro¿ov, Czechia
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Opava, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Tübingen, Baden-Wurttemberg, Germany
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München, Bavaria, Germany
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Bonn, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Berlin, Germany
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Bonn, Germany
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Düsseldorf, Germany
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Herten, Germany
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Magdeburg, Germany
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München, Germany
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Tübingen, Germany
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Balassagyarmat, Hungary
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Budapest, Hungary
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Cegléd, Hungary
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Debrecen, Hungary
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Eger, Hungary
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Gy¿r, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Szeged, Hungary
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Szolnok, Hungary
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Bergen, Norway
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Drammen, Norway
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Hagavik, Norway
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Stavanger, Norway
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Stokmarknes, Norway
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Straume, Norway
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Tønsberg, Norway
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Brasov, Romania
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Bucharest, Romania
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Iași, Romania
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Banská Bystrica, Slovakia
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Bojnice, Slovakia
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Bratislava, Slovakia
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Domaša, Slovakia
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Ko¿ice, Slovakia
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Liptovský Mikulá¿, Slovakia
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Michalovce Strá¿any, Slovakia
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Nitra, Slovakia
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Pre¿ov, Slovakia
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Rimavská Sobota, Slovakia
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¿ilina-Byt¿ica, Slovakia
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¿ilina, Slovakia
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Medunsa, Pretoria, South Africa
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Bloemfontein, South Africa
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CapeTown, South Africa
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Durban, South Africa
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Ga-Rankuwa, South Africa
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Johannesburg, South Africa
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Krugersdorp, South Africa
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Parktown, South Africa
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Pretoria, South Africa
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Tygerberg, South Africa
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Sutton Coldfield, West Midlands, United Kingdom
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Birmingham, United Kingdom
Related Publications (1)
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.
PMID: 19358783DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca CNS Medical Group
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
April 1, 2004
Study Completion
October 1, 2005
Last Updated
January 4, 2013
Record last verified: 2013-01