Seroquel on Glucose Metabolism

Schizophrenia Clinical Trial

Official title:

Seroquel on Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214578
• Other study ID #: D1441C00125
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: January 3, 2013
• Start date: April 2004
• Est. completion date: October 2005

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyNorway: Norwegian Medicines AgencyRomania: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Seroquel (quetiapine)

Locations

Country	Name	City	State
Bulgaria	Research Site	Burgas
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Russe
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia- Novi Iskar
Bulgaria	Research Site	Varna
Czech Republic	Research Site	Dob¿any u Plzn¿
Czech Republic	Research Site	Dobjany
Czech Republic	Research Site	Havlí¿k¿v Brod
Czech Republic	Research Site	Kladno
Czech Republic	Research Site	Miro¿ov
Czech Republic	Research Site	Opava
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Praha 10
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha 5
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Praha 8
Germany	Research Site	Berlin
Germany	Research Site	Bonn
Germany	Research Site	Bonn	Nordrhein-Westfalen
Germany	Research Site	Düsseldorf	Nordrhein-Westfalen
Germany	Research Site	Düsseldorf
Germany	Research Site	Herten
Germany	Research Site	Magdeburg
Germany	Research Site	Magdeburg	Sachsen-Anhalt
Germany	Research Site	München	Bayern
Germany	Research Site	München
Germany	Research Site	Münster	Nordrhein-Westfalen
Germany	Research Site	Tübingen	Baden-Württemberg
Germany	Research Site	Tübingen
Hungary	Research Site	Balassagyarmat
Hungary	Research Site	Budapest
Hungary	Research Site	Cegléd
Hungary	Research Site	Debrecen
Hungary	Research Site	Eger
Hungary	Research Site	Gy¿r
Hungary	Research Site	Kaposvár
Hungary	Research Site	Kecskemét
Hungary	Research Site	Szeged
Hungary	Research Site	Szolnok
Norway	Research Site	Bergen
Norway	Research Site	Drammen
Norway	Research Site	Hagavik
Norway	Research Site	Stavanger
Norway	Research Site	Stokmarknes
Norway	Research Site	Straume
Norway	Research Site	Tønsberg
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Iasi
Slovakia	Research Site	¿ilina
Slovakia	Research Site	¿ilina-Byt¿ica
Slovakia	Research Site	Banská Bystrica
Slovakia	Research Site	Bojnice
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Hronovce
Slovakia	Research Site	Ko¿ice
Slovakia	Research Site	Liptovský Mikulá¿
Slovakia	Research Site	Michalovce Strá¿any
Slovakia	Research Site	Nitra
Slovakia	Research Site	Pre¿ov
Slovakia	Research Site	Rimavská Sobota
South Africa	Research Site	Bloemfontein
South Africa	Research Site	CapeTown
South Africa	Research Site	Durban
South Africa	Research Site	Ga-Rankuwa
South Africa	Research Site	Johannesburg
South Africa	Research Site	Krugersdorp
South Africa	Research Site	Medunsa	Pretoria
South Africa	Research Site	Parktown
South Africa	Research Site	Pretoria
South Africa	Research Site	Tygerberg
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Sutton Coldfield	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Germany,  Hungary,  Norway,  Romania,  Slovakia,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
Secondary	Glucose metabolism, blood lipid levels and weight