Clinical trial NCT00214578: Seroquel on Glucose Metabolism
Official title: Seroquel on Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
Secondary outcomes:
measure: Glucose metabolism, blood lipid levels and weight
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Russe
country: Bulgaria
facility: Research Site
city: Sofia- Novi Iskar
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Dobjany
country: Czech Republic
facility: Research Site
city: Dob¿any u Plzn¿
country: Czech Republic
facility: Research Site
city: Havlí¿k¿v Brod
country: Czech Republic
facility: Research Site
city: Kladno
country: Czech Republic
facility: Research Site
city: Miro¿ov
country: Czech Republic
facility: Research Site
city: Opava
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Praha 10
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Praha 8
country: Czech Republic
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
state: Baden-Württemberg
city: München
country: Germany
facility: Research Site
state: Bayern
city: Bonn
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: Research Site
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Herten
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
city: Balassagyarmat
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Cegléd
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Gy¿r
country: Hungary
facility: Research Site
city: Kaposvár
country: Hungary
facility: Research Site
city: Kecskemét
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Drammen
country: Norway
facility: Research Site
city: Hagavik
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Stokmarknes
country: Norway
facility: Research Site
city: Straume
country: Norway
facility: Research Site
city: Tønsberg
country: Norway
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Banská Bystrica
country: Slovakia
facility: Research Site
city: Bojnice
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Hronovce
country: Slovakia
facility: Research Site
city: Ko¿ice
country: Slovakia
facility: Research Site
city: Liptovský Mikulá¿
country: Slovakia
facility: Research Site
city: Michalovce Strá¿any
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Pre¿ov
country: Slovakia
facility: Research Site
city: Rimavská Sobota
country: Slovakia
facility: Research Site
city: ¿ilina-Byt¿ica
country: Slovakia
facility: Research Site
city: ¿ilina
country: Slovakia
facility: Research Site
city: Medunsa
country: South Africa
facility: Research Site
state: Pretoria
city: Bloemfontein
country: South Africa
facility: Research Site
city: CapeTown
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Ga-Rankuwa
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Krugersdorp
country: South Africa
facility: Research Site
city: Parktown
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Tygerberg
country: South Africa
facility: Research Site
city: Sutton Coldfield
country: United Kingdom
facility: Research Site
state: West Midlands
city: Birmingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca CNS Medical Group
role: STUDY_DIRECTOR
References:
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.