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| Descriptive Information Fields | |||||||||
| Brief Title † | Comparison of Antipsychotics for Metabolic Problems in the Treatment of People With Schizophrenia or Schizoaffective Disorder | ||||||||
| Official Title † | Clinical Management of Metabolic Problems in Patients With Schizophrenia | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Mean difference in non-HDL cholesterol level changes between patients assigned to stay compared to patients assigned to switch at the last observation. [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Efficacy failure, defined as psychiatric hospitalization, a 25 percent increase from baseline on the Positive and Negative Syndrome Scale or substantial clinical deterioration on the Clinical Global Impressions-Change (CGI-C) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: Yes ] | ||||||||
| Condition † | Schizophrenia Schizoaffective Disorder |
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| Intervention † | Drug: Risperidone Drug: Olanzapine Drug: Quetiapine Drug: Aripiprazole Behavioral: Intervention used to control diet and modify activity level |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 300 | ||||||||
| Start Date † | January 2007 | ||||||||
| Completion Date | July 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00423878 | ||||||||
| Organization ID | STROUP06STN0 | ||||||||
| Secondary IDs †† | DSIR AT-AP | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | January 16, 2007 | ||||||||
| Last Updated Date | August 21, 2008 | ||||||||
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