Schizophrenia Clinical Trial
Official title:
Effects of the Serotonin 2A Receptor on Insulin Sensitivity and Secretion: a Double-blind Controlled Comparison of Olanzapine vs. Amisulpride:
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. These drugs are called atypical drugs and exert their action in part by occupying receptors for serotonin, particularly the 5HT2A receptor subtype. This receptor may also interfere with glucose metabolism and insulin action. The purpose of this study is to compare an atypical antipsychotic drugs, olanzapine, which acts by occupying the 5HT2A receptor, to another antipsychotic drug, amisulpride, which mainly acts through the dopamine pathway. Healthy volunteers are recruited and asked to take a single dose of each drug and of placebo on separate days. Then, a combined glucose clamp study will be performed in order to test the effects of these drugs on insulin sensitivity and insulin secretion.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2006 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - healthy male volunteers - written informed consent Exclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Germany | Central Institute of Mental Health | Mannheim |
Lead Sponsor | Collaborator |
---|---|
Central Institute of Mental Health, Mannheim | Sanofi |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | insulin sensitivity | m-value during euglycemic glucose clamp (glucose infusion rate divided by time and body weight) | 90 thru 120 min after application of study drug | Yes |
Secondary | pancratic c-peptide secretion | C-peptide measured 4 times during hyperglycemic clamp period at time 0 min (prior to glucose bolus), 5 min, 10 min and 60 min after glucose bolus | 120 thru 180 minutes after administration of study drug | Yes |
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