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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00338949 |
This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.
Condition | Intervention | Phase |
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Schizophrenia Metabolic Syndrome X Insulin Resistance |
Drug: Ziprasidone Drug: Standard atypical antipsychotic drug |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Metabolic Syndrome in Patients With Schizophrenia |
Estimated Enrollment: | 77 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: Active Comparator
Participants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone
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Drug: Standard atypical antipsychotic drug
Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.
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Switch: Experimental
Participants who enter on risperidone or olanzapine and switch to ziprasidone
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Drug: Ziprasidone
Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.
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People with schizophrenia often lead more sedentary lifestyles than people without the disease, and they are frequently treated with antipsychotic medications that cause weight gain. Combined, these factors produce an increased risk for metabolic syndrome, which can lead to heart disease and type 2 diabetes. Characteristics of metabolic syndrome include carrying excess weight around the abdominal region; high blood pressure; high blood sugar levels; high levels of fat in the blood; and low levels of HDL cholesterol. Recent studies have shown that certain atypical antipsychotic drugs are relatively weight-neutral. Switching from a drug that promotes weight gain to a weight-neutral medication, such as ziprasidone, may result in significant weight loss. There is insufficient evidence, however, demonstrating the extent of improvement in insulin sensitivity after switching medications. This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.
Participants in this open label study will currently be undergoing treatment with risperidone or olanzapine at the time of study entry. Upon study entry, they will be randomly assigned to either switch to ziprasidone treatment or remain on their current medications. Both groups will be treated for 26 weeks. Participants will report to the study site for evaluations biweekly until week 10 and then monthly for the duration of the study. The following outcomes will be assessed at study entry and Week 26: insulin sensitivity, using an intravenous glucose tolerance test; visceral fat mass, using a CT scan; and total adiposity, using a dexascan.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tanya Baker, BS | 858-552-8585 ext 2875 | tanyab@ucsd.edu |
Contact: Jonathan M. Meyer, MD | 858-642-3570 | jmmeyer@ucsd.edu |
United States, California | |
VA San Diego Healthcare System | Recruiting |
San Diego, California, United States, 92161 | |
Principal Investigator: Jonathan M. Meyer, MD |
Principal Investigator: | Jonathan M. Meyer, MD | University of California, San Diego & VA San Diego Healthcare System |
Responsible Party: | University of California, San Diego ( Jonathan M. Meyer, MD ) |
Study ID Numbers: | K23 MH74540, DATR AK-TNET1 |
Study First Received: | June 16, 2006 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00338949 |
Health Authority: | United States: Federal Government |
Ziprasidone Olanzapine Risperidone Schizoaffective Disorder |
Insulin Sensitivity Visceral Adiposity Metabolic Syndrome |
Obesity Metabolic Syndrome X Metabolic Diseases Risperidone Olanzapine Diabetes Mellitus Serotonin Insulin Schizophrenia Hyperinsulinism |
Dopamine Mental Disorders Syndrome X Psychotic Disorders Insulin Resistance Ziprasidone Metabolic disorder Glucose Metabolism Disorders Schizophrenia and Disorders with Psychotic Features Abdominal obesity metabolic syndrome |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Syndrome Dopamine Agents Central Nervous System Agents |