Seroquel on Glucose Metabolism

NCT ID: NCT00214578

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

572 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Seroquel (quetiapine)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca CNS Medical Group

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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Bulgaria Czechia Germany Hungary Norway Romania Slovakia South Africa United Kingdom

References

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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.

Reference Type DERIVED
PMID: 19358783 (View on PubMed)

Other Identifiers

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D1441C00125

Identifier Type: -

Identifier Source: org_study_id

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