Status:
COMPLETED
Effect of Atypical Antipsychotic Drugs Olanzapine and Amisulpride on Glucose Metabolism
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Collaborating Sponsors:
Sanofi
Conditions:
Schizophrenia
Diabetes
Eligibility:
MALE
18-65 years
Phase:
NA
Brief Summary
Patients suffering from schizophrenia have a high risk to become obese and develop diabetes. Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine or olanzapine. ...
Detailed Description
10 male healthy volunteers are recruited. After informed consent, they are admitted to the study ward at 10:00 p.m. prior to the study day and kept fasting until the next morning. At 8:00 a.m. they re...
Eligibility Criteria
Inclusion
- healthy male volunteers
- written informed consent
Exclusion
- BMI \> 30 kg/m²
- Diabetes mellitus
- Hypertension
- Treatment with drugs interfering with lipid or glucose metabolism (e.g. statins, oral antidiabetic drugs, glucocorticoids)
- History of seizures
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01160991
Start Date
May 1 2004
End Date
October 1 2006
Last Update
August 3 2010
Active Locations (1)
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1
Central Institute of Mental Health
Mannheim, Germany, 68159