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Sponsors and Collaborators: |
Washington University School of Medicine National Institutes of Health (NIH) |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00515723 |
Hyperglycemia and type 2 diabetes mellitus are more common in schizophrenia than in the general population. Type 2 diabetes mellitus is characterized by disturbances in insulin action on skeletal muscle, liver and adipose tissue. Diabetes causes increased morbidity and mortality due to acute (e.g., diabetic ketoacidosis) and long-term (e.g., cardiovascular disease) complications. The combination of hyperglycemia, dyslipidemia and abdominal adiposity is even more strongly associated with increased cardiovascular morbidity and mortality. The association of type 2 diabetes and hyperglycemia with schizophrenia was first noted prior to the introduction of antipsychotic medications, suggesting that these patients may be at increased risk. Since then, however, additional glucoregulatory abnormalities (e.g., new onset diabetes), dyslipidemia, and increased weight and adiposity have all been associated with antipsychotic medications. Concern about antipsychotic effects on glucose, lipids and adiposity has increased recently, focusing on the widely-used newer medications, clozapine and olanzapine. Increased abdominal adiposity can secondarily decrease insulin sensitivity and antipsychotics can increase adiposity. However, medication effects on glucose control and insulin action may also occur independent of differences in adiposity. This project aims to a) evaluate the effects of selected antipsychotic medications on insulin action in skeletal muscle (glucose disposal), liver (glucose production) and adipose tissue (whole-body lipolysis), b) evaluate the effects of selected antipsychotic medications on abdominal adipose tissue mass, total body fat and total fat-free mass, and c) explore the longitudinal effects of treatment with selected antipsychotics on glucose tolerance, lipid profiles, abdominal adipose tissue mass, total body fat and total fat-free mass. These hypotheses will be evaluated by measuring 1) whole-body glucose and lipid kinetics with the use of "gold-standard" stable isotope tracer methodology, 2) body composition using dual energy x-ray absorptiometry and magnetic resonance imaging, and 3) longitudinal changes in glucose tolerance and lipid profiles. The aims will be addressed in non-diabetic schizophrenia patients chronically treated with risperidone, olanzapine, clozapine, quetiapine, ziprasidone, or haloperidol, and untreated healthy controls.
Re-evaluations will also be performed in patients who are randomized to switch from their current antipsychotic (from the above groups) to risperidone, olanzapine, quetiapine, or ziprasidone for 6 months. Relevant data is critically needed to target basic research, identify long-term cardiovascular consequences, and plan therapeutic interventions.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder Type 2 Diabetes Mellitus Hyperglycemia |
Drug: risperidone Drug: olanzapine Drug: quetiapine Drug: ziprasidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Glucose and Lipid Metabolism on Antipsychotic Medication |
Estimated Enrollment: | 120 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Randomized switch from current antipsychotic treatment to either olanzapine, risperidone, ziprasidone, or quetiapine.
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Drug: risperidone
randomized switch from current antipsychotic treatment to risperidone
Drug: olanzapine
randomized switch from current antipsychotic treatment to olanzapine
Drug: quetiapine
randomized switch from current antipsychotic treatment to quetiapine
Drug: ziprasidone
randomized switch from current antipsychotic treatment to ziprasidone
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Washington Univeristy School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
Washington University School of Medicine, Psychiatry Dept. | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | John W Newcomer, MD | Washington Univerisity Schoole of Medicine |
Responsible Party: | Washington University School of Medicine ( John Newcomer, MD ) |
Study ID Numbers: | R01 MH063985-04 |
Study First Received: | August 13, 2007 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00515723 History of Changes |
Health Authority: | United States: Institutional Review Board |
control risperidone olanzapine quetiapine ziprasidone |
Neurotransmitter Agents Olanzapine Psychotropic Drugs Antiemetics Schizophrenia Hyperglycemia Dopamine Mental Disorders Psychotic Disorders Metabolic Disorder Schizophrenia and Disorders with Psychotic Features Metabolic Diseases Tranquilizing Agents Diabetes Mellitus |
Risperidone Endocrine System Diseases Central Nervous System Depressants Antipsychotic Agents Serotonin Uptake Inhibitors Serotonin Quetiapine Diabetes Mellitus, Type 2 Dopamine Agents Peripheral Nervous System Agents Endocrinopathy Glucose Metabolism Disorders Ziprasidone |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Schizophrenia Serotonin Antagonists Hyperglycemia Mental Disorders Therapeutic Uses Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Metabolic Diseases |
Tranquilizing Agents Gastrointestinal Agents Risperidone Diabetes Mellitus Endocrine System Diseases Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Quetiapine Serotonin Agents Autonomic Agents Diabetes Mellitus, Type 2 Dopamine Agents |