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| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborators: |
Janssen, LP Washington University School of Medicine |
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00006195 |
Purpose
The overall purpose of this research is to look at how two of the most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, affect substances in the body such as glucose and insulin. Undesirable changes in blood sugar control, or glucose regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia compared to healthy subjects and subjects with other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia before the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Attention to the way that antipsychotic medications may affect glucose regulation has increased as doctors have become more concerned in general about disease- and drug-related medical complications, including weight gain during antipsychotic treatment.
| Condition | Intervention |
|---|---|
|
Schizophrenia |
Drug: risperidone Drug: olanzapine |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
This study will include 70 patients diagnosed with schizophrenia, taking either risperidone, olanzapine or haloperidol, and 20 healthy control subjects. Each subject will undergo a 4 hour glucose tolerance test. In addition, there will be a small project within the overall study to measure the effects of risperidone and olanzapine on glucose regulation as the individuals switch from their prior treatment with a conventional antipsychotic medication to either risperidone or olanzapine. Ten subjects will be studied on a typical neuroleptic at baseline then switched over a one week period to risperidone or olanzapine. The participants will be evaluated at 1 week, 4 weeks, and 12 weeks, prospectively. Each evaluation will consist of a 4 hour glucose tolerance test.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contacts and Locations| Contact: John Newcomer, M.D. | 1-314-362-2459 | newcomej@psychiatry.wustl.edu |
| United States, Missouri | |
| Washington University | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: John Newcomer, M.D. | |
More Information
| Study ID Numbers: | NCRR-M01RR00036-0752, M01RR00036 |
| Study First Received: | September 7, 2000 |
| Last Updated: | October 11, 2006 |
| ClinicalTrials.gov Identifier: | NCT00006195 History of Changes |
| Health Authority: | United States: Federal Government |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Schizophrenia Serotonin Antagonists Mental Disorders Therapeutic Uses Schizophrenia and Disorders with Psychotic Features Tranquilizing Agents |
Risperidone Gastrointestinal Agents Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
