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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: | NCT00423878 |
The study will compare the effectiveness of antipsychotic medications for patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder |
Drug: Risperidone Drug: Olanzapine Drug: Quetiapine Drug: Aripiprazole Behavioral: Intervention used to control diet and modify activity level |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Management of Metabolic Problems in Patients With Schizophrenia |
Estimated Enrollment: | 300 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will switch to aripiprazole.
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Drug: Aripiprazole
Switching medication to aripiprazole for schizophrenia for up to 6 months in study
Behavioral: Intervention used to control diet and modify activity level
Promotion of healthy behavioral habits
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2: Active Comparator
Participants will continue treatment with olanzapine, quetiapine, or risperidone.
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Drug: Risperidone
Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study
Drug: Olanzapine
Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study
Drug: Quetiapine
Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study
Behavioral: Intervention used to control diet and modify activity level
Promotion of healthy behavioral habits
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Metabolic abnormalities associated with cardiovascular morbidity and premature mortality are more common in patients with schizophrenia than in matched controls. Although there is some evidence that patients with schizophrenia have intrinsic abnormalities in lipid and carbohydrate metabolism, some antipsychotics (i.e., clozapine, olanzapine, quetiapine, and risperidone) are associated with increased rates of metabolic abnormalities that predispose patients to cardiovascular disease.
This is an investigator-initiated clinical trial that will be conducted at 30 research sites that are a part of the NIMH Schizophrenia Trials Network.
The aims of the study are to (1) determine the relative effects of switching to aripiprazole, versus continued treatment with olanzapine, quetiapine, or risperidone, on metabolic parameters associated with cardiovascular disease, and (2) to determine the effects of switching to aripiprazole versus continued treatment with olanzapine, quetiapine, or risperidone on the clinical stability of schizophrenic illness.
This study design is a multi-site, single-blind (rater) randomized controlled trial of 300 patients with schizophrenia or schizoaffective disorder comparing treatment with the following medications: olanzapine, quetiapine, risperidone, and aripiprazole. The study will enroll patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease in spite of adequate control of symptoms on their current antipsychotic medication. Patients who are taking olanzapine, quetiapine, or risperidone and who have a body-mass index (BMI) greater than or equal to 27 and non-HDL cholesterol greater than or equal to 130 mg/dl will be eligible (if non-HDL is between 130-139mg/dL, LDL cholesterol must be greater than 100mg/dL). All treatments will be open label. Raters will be blinded to treatment assignment. Patients will be followed for up to 6 months.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marianne Livingston, MSW | 919-966-9587 | marianne_livingston@med.unc.edu |
Contact: Ingrid Rojas, MPM | 919-843-7365 | stn@med.unc.edu |
Principal Investigator: | T. Scott Stroup, MD, MPH | The University of North Carolina at Chapel Hill |
Study Director: | Joseph P McEvoy, MD | Duke University |
Responsible Party: | University of North Carolina, Chapel Hill ( T. Scott Stroup, MD, MPH ) |
Study ID Numbers: | STROUP06STN0, DSIR AT-AP |
Study First Received: | January 16, 2007 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00423878 |
Health Authority: | United States: Federal Government |
Schizophrenia Quetiapine Dopamine Mental Disorders Risperidone |
Olanzapine Psychotic Disorders Aripiprazole Serotonin 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 Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |