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| Sponsors and Collaborators: |
Manhattan Psychiatric Center Eli Lilly and Company |
|---|---|
| Information provided by: | Manhattan Psychiatric Center |
| ClinicalTrials.gov Identifier: | NCT00287820 |
Purpose
The primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels. The main secondary objective is to evaluate whether the increase in glucose levels and rate of glucose abnormalities differs between Olanzapine and Risperidone during this treatment period. Additional secondary objectives of the study are to investigate similar questions with respect to glycohemoglobin, triglycerides and other measures of glucose and lipid metabolism.
We hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in the primary outcome measure of serum glucose, and secondary measures of glycohemoglobin, insulin and lipids.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Diabetes Metabolic Syndrome Hyperglycemia |
Drug: Olanzapine Drug: olanzapine Drug: risperidone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Independent Investigator Grant Study-Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism |
| Estimated Enrollment: | 46 |
| Study Start Date: | February 2004 |
| Study Completion Date: | September 2007 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
olanzapine
|
Drug: Olanzapine
olanzapine 5-40 mg/day
Drug: olanzapine
olanzapine 5-40 ,mg/day
|
|
2: Active Comparator
risperidone
|
Drug: risperidone
risperidone 1-12 mg/day
|
In the on-going study in progress we use an extensive battery of assessments to investigate a)fasting levels of glucose and lipids at baseline and monthly during 5 months of treatment, b) glucose tolerance tests to investigate glucose and insulin abnormalities after a glucose load at baseline and during study treatment, and c)the effects of treatment with olanzapine and risperidone of post prandial glucose metabolism after a fatty meal (as detailed in the body of the proposal). Recent studies have shown that increased postprandial lipidemia is an important feature of many patients with type 2 diabetes and atherosclerosis. In addition to the biochemical measures, we will also assess clinical effects (PANSS and CGI ratings) and other side-effects (weight gain, appetite, somnolence, and EPS and TD). The specific plan calls for inpatients in a tertiary care hospital to be randomly assigned to olanzapine or risperidone, using a stratified random assignment procedure, and treated for five months with either olanzapine or risperidone. We estimate that we will have to enroll a sample of approximately 50-55 patients to obtain 46 acceptable complete cases(as specified in proposal below). On the basis of preliminary results from our prior and ongoing studies we predict no significant increase in glucose abnormalities from baseline during chronic treatment with olanzapine and no significant differences in development of glucose abnormalities in patients in patient treated with olanzapine and risperidone.
Additional measures being investigated include: comparison of olanzapine and risperidone in glucose and lipid responses to a fatty meal, ghrelin changes in response to a fatty mean, and CRP and IL-6, and thyroid and prolactin response to five months of treatment with the two drugs.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Manhattan Psychaitric Center | |
| New York, New York, United States, 10035 | |
| Principal Investigator: | Robert C Smith, MD PhD | NYU Medical School, Dept of Psychiatry and Manhattan Psychiatric Center |
More Information
| Responsible Party: | Manhatan Psychiatric Center ( Robert C. Smith MD ) |
| Study ID Numbers: | FiD-MC-x226(7524) |
| Study First Received: | February 6, 2006 |
| Last Updated: | January 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00287820 |
| Health Authority: | United States: Institutional Review Board |
|
schizophrenia diabetes metabolic syndrome hyperglycemia glucose |
insulin lipids IL-6 prolactin |
|
Metabolic Diseases Diabetes Mellitus Olanzapine Risperidone Insulin Serotonin Schizophrenia |
Dopamine Hyperglycemia Mental Disorders Psychotic Disorders Glucose Metabolism Disorders Metabolic disorder Schizophrenia and Disorders with Psychotic Features |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Autonomic Agents Therapeutic Uses Syndrome Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
