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Effect of Atypical Antipsychotic Drugs Olanzapine and Amisulpride on Glucose Metabolism

NCT01160991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-08-03

No results posted yet for this study

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. 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.

Conditions

Interventions

PROCEDURE

Glucose clamp technique

euglycemic hyperinsulinemic clamp with target blood glucose of 90 mg/dl (5 mmol/l), followed by hyperglycemic clamp, target blood glucose of 180 mg/dl (10 mmol/l) for measurement of insulin sensitivity and insulin secretion

DRUG

Amisulpride

Single dose of amisulpride 200 mg p.o. given at 8:00 a.m.

DRUG

Olanzapine

Single dose of olanzapine 10 mg p.o. given at 8:00 a.m.

DRUG

Placebo

Placebo capsules are given at 8:00 a.m.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Central Institute of Mental Health, Mannheim

    lead OTHER

Principal Investigators

  • Daniel Kopf, M.D. · Central Institute of Mental Health, Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01160991 on ClinicalTrials.gov