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Sponsored by: |
Manhattan Psychiatric Center |
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Information provided by: | Manhattan Psychiatric Center |
ClinicalTrials.gov Identifier: | NCT00231894 |
This is a study with an approved drug for treating type 2 diabetes, for its effects on treating glucose and lipid abnormalities in patients being treated with olanzapine and clozapine, and comparison of effects of this drug with another treatment lifestyle modification. Patients who meet inclusion criteria will be treated with pioglitazone for 12 weeks. They will be evaluated for fasting glucose and lipids, glucose-tolerance tests, and neurocognitive battery and tests of verbal memory at baseline and during treatment with pioglitazone.
Condition | Intervention |
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Diabetes Schizophrenia Insulin Resistance Cognitive Impairment |
Drug: Pioglitazone Behavioral: Life style diet group Other: placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia Treated With Clozapine and Olanzapine And Potential Effects on Cognitive Function |
Estimated Enrollment: | 40 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | February 2009 |
Arms | Assigned Interventions |
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1: Active Comparator
pioglitazone
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Drug: Pioglitazone
pioglitazone 15-45 mg/day
Behavioral: Life style diet group
life style diet education group 1x/week
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2: Placebo Comparator
placebo
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Behavioral: Life style diet group
life style diet education group 1x/week
Other: placebo
placebo comparator
|
The aim of this study is to investigate the effects of pioglitazone added to weight-lifestyle intervention vs. placebo plus lifestyle intervention on reversing or reducing impaired or abnormal triglycerides, HDL and glucose metabolism in schizophrenics treated with clozapine or olanzapine. Another aim is to examine the effects of impaired glucose metabolism on verbal memory and other cognitive function in schizophrenic patients treated with these medications and the relationship to improvements in impaired glucose metabolism to impairments in cognitive function. Clozapine and olanzapine, two second generation antipsychotics effective for treating schizophrenia and bipolar disorders, have been reported to be associated with increased incidence of diabetic type metabolic abnormalities, decreases in insulin sensitivity, and abnormal glucose tolerance tests. This can lead to the development of type 2 diabetes and also abnormal lipid metabolic levels which can lead to atherosclerotic changes and increased risk of cardiovascular disease and other diabetes related complications. Drug treatments which could reduce or correct these diabetic metabolic changes would permit many patients to continue to receive the benefits of these antipsychotic medications with reduced drug-induced comorbidity. Previous research using non-psychotic subjects has shown that diabetes and impaired glucose tolerance are associated with cognitive impairments, especially in verbal memory, and provides a rationale for testing whether corrections of impaired glucose metabolism are associated with cognitive improvements in schizophrenic patients.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will have evidence of:
Exclusion Criteria:
Contact: Robert C Smith, MD PhD | 646-672-6910 | robert.smith@med.nyu.edu |
United States, New York | |
Manhattan Psychiatric Center | Recruiting |
New York, New York, United States, 10035 | |
Contact: James Cornwell, Ba 646-672-6964 marctvv@omh.state.ny.us | |
Principal Investigator: Robert C Smith, MD PhD |
Principal Investigator: | Robert C Smith, MD PhD | NYU School of Medicine & Manhattan Psychiatric Center |
Responsible Party: | Manattan Psychiatric Center, NYU Medical School ( Robert C. Smith MD, PhD ) |
Study ID Numbers: | 04T-584 Stanley Foundation, 04T-584 |
Study First Received: | October 3, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00231894 History of Changes |
Health Authority: | United States: Institutional Review Board |
atypical antipsychotics hyperglycemia triglycerides HDL |
cholesterol insulin resistance schizophrenia verbal memory |
Metabolic Diseases Pioglitazone Olanzapine Diabetes Mellitus Antipsychotic Agents Insulin Cognition Disorders Schizophrenia Hyperinsulinism Hypoglycemic Agents Delirium, Dementia, Amnestic, Cognitive Disorders |
Hyperglycemia Mental Disorders Clozapine Psychotic Disorders Insulin Resistance Congenital Abnormalities Glucose Metabolism Disorders Dementia Metabolic Disorder Schizophrenia and Disorders with Psychotic Features Delirium |
Metabolic Diseases Pioglitazone Physiological Effects of Drugs Cognition Disorders Pharmacologic Actions Schizophrenia Hyperinsulinism |
Delirium, Dementia, Amnestic, Cognitive Disorders Hypoglycemic Agents Mental Disorders Insulin Resistance Glucose Metabolism Disorders Schizophrenia and Disorders with Psychotic Features |