Comparison of Antipsychotics for Metabolic Problems (CAMP): A NIMH schizophrenia trials network study

Because of growing concern about the physical health status of persons with schizophrenia and uncertainty regarding optimal strategies to manage metabolic side effects of antipsychotic drugs that increase the risk of cardiovascular disease, we developed a protocol to test the effectiveness of a common strategy - switching to an antipsychotic associated with lower risk of metabolic side effects. In this study we will randomly assign individuals with schizophrenia or schizoaffective disorder who have increased BMI (≥27) and elevated non-HDL cholesterol (≥160 mg/dL) to stay on their current stable dose of olanzapine, quetiapine, or risperidone, or to switch to aripiprazole. All study participants will receive a behavioral treatment that is aimed at modifying cardiovascular risk factors, including weight, activity level, blood sugar, blood pressure, and lipids. Because non-HDL cholesterol is a significant predictor of cardiovascular disease and has some advantages over total cholesterol and LDL cholesterol, the primary outcome will be change in non-HDL cholesterol. Other important metabolic parameters, including fasting blood sugar, glycosylated hemoglobin, triglycerides, and weight will be examined. The study will also examine the effects of switching medications on the status of psychotic illness. Follow-up in the study is six months. The study is underway using the Schizophrenia Trials Network, a research infrastructure established by the National Institute of Mental Health to conduct the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Schizophrenia Trial. ClinicalTrials.gov Identifier: NCT00423878.