Seroquel on Glucose Metabolism

Condition(s) targeted: Schizophrenia

Intervention: Seroquel (quetiapine) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca CNS Medical Group, Study Director, Affiliation: AstraZeneca

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

Official title: Seroquel on Glucose Metabolism

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary outcome: To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients

Secondary outcome: Glucose metabolism, blood lipid levels and weight

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Research Site, Burgas, Bulgaria

Research Site, Sofia, Bulgaria

Research Site, Ruse, Bulgaria

Research Site, Varna, Bulgaria

Research Site, Russe, Bulgaria

Research Site, Sofia- Novi Iskar, Bulgaria

Research Site, Dobjany, Czech Republic

Research Site, KLADNO, Czech Republic

Research Site, Opava, Czech Republic

Research Site, Praha 10, Czech Republic

Research Site, Praha 2, Czech Republic

Research Site, Praha 5, Czech Republic

Research Site, Praha 8, Czech Republic

Research Site, Dob¿any u Plzn¿, Czech Republic

Research Site, Havlí¿k¿v Brod, Czech Republic

Research Site, Miro¿ov, Czech Republic

Research Site, Plzen, Czech Republic

Research Site, Praha 6, Czech Republic

Research Site, Berlin, Germany

Research Site, Herten, Germany

Research Site, Magdeburg, Germany

Research Site, München, Germany

Research Site, Bonn, Germany

Research Site, Düsseldorf, Germany

Research Site, Tübingen, Germany

Research Site, Balassagyarmat, Hungary

Research Site, Budapest, 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, Hungary

Research Site, Cegléd, Hungary

Research Site, Debrecen, Hungary

Research Site, Bergen, Norway

Research Site, Tønsberg, Norway

Research Site, Drammen, Norway

Research Site, Hagavik, Norway

Research Site, STAVANGER, Norway

Research Site, STOKMARKNES, Norway

Research Site, STRAUME, Norway

Research Site, Brasov, Romania

Research Site, Bucharest, Romania

Research Site, IASI, Romania

Research Site, Bucuresti, Romania

Research Site, Bojnice, Slovakia

Research Site, Bratislava, Slovakia

Research Site, Hronovce, Slovakia

Research Site, ¿ilina, Slovakia

Research Site, ¿ilina-Byt¿ica, 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, Slovakia

Research Site, Banská Bystrica, Slovakia

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, Parktown, South Africa

Research Site, Pretoria, South Africa

Research Site, Tygerberg, South Africa

Research Site, Birmingham, United Kingdom

Research Site, BIRMINGHAM, United Kingdom

Research Site, Tübingen, Baden-Württemberg, Germany

Research Site, München, Bayern, Germany

Research Site, Düsseldorf, Nordrhein-Westfalen, Germany

Research Site, Münster, Nordrhein-Westfalen, Germany

Research Site, Bonn, Nordrhein-Westfalen, Germany

Research Site, Medunsa, Pretoria, South Africa

Research Site, Magdeburg, Sachsen-Anhalt, Germany

Research Site, Sutton Coldfield, West Midlands, United Kingdom

Starting date: April 2004
Last updated: March 7, 2007