Seroquel on Glucose Metabolism

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00214578
• Date of registration: 14/09/2005
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Seroquel on Glucose Metabolism
• Scientific title: Seroquel on Glucose Metabolism
• Date of first enrolment: April 2004
• Target sample size: 572
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00214578
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

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

Contacts

• Name: AstraZeneca CNS Medical Group
• Affiliation: AstraZeneca

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Seroquel (quetiapine)

Primary Outcome(s)

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

Secondary Outcome(s)

Glucose metabolism, blood lipid levels and weight

Secondary ID(s)

D1441C00125

Source(s) of Monetary Support

Please refer to primary and secondary sponsors