Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes
|Schizophrenia Metabolic Syndrome X Insulin Resistance||Drug: Ziprasidone Drug: Standard atypical antipsychotic drug||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Metabolic Syndrome in Patients With Schizophrenia|
- Insulin sensitivity [ Time Frame: Measured at Week 26 ]
- Visceral fat mass [ Time Frame: Measured at Week 26 ]
- Total adiposity [ Time Frame: 26 weeks ]
- Body mass index [ Time Frame: Measured at Week 26 ]
- Fasting glucose [ Time Frame: Measured at Week 26 ]
- Fasting lipids [ Time Frame: Measured at Week 26 ]
- Fasting insulin [ Time Frame: Measured at Week 26 ]
- Total psychiatric hospital days [ Time Frame: Measured at Week 26 ]
|Study Start Date:||June 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Control
Participants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone
Drug: Standard atypical antipsychotic drug
Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.
Participants who enter on risperidone or olanzapine and switch to ziprasidone
Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.
People with schizophrenia often lead more sedentary lifestyles than people without the disease, and they are frequently treated with antipsychotic medications that cause weight gain. Combined, these factors produce an increased risk for metabolic syndrome, which can lead to heart disease and type 2 diabetes. Characteristics of metabolic syndrome include carrying excess weight around the abdominal region; high blood pressure; high blood sugar levels; high levels of fat in the blood; and low levels of HDL cholesterol. Recent studies have shown that certain atypical antipsychotic drugs are relatively weight-neutral. Switching from a drug that promotes weight gain to a weight-neutral medication, such as ziprasidone, may result in significant weight loss. There is insufficient evidence, however, demonstrating the extent of improvement in insulin sensitivity after switching medications. This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.
Participants in this open label study will currently be undergoing treatment with risperidone or olanzapine at the time of study entry. Upon study entry, they will be randomly assigned to either switch to ziprasidone treatment or remain on their current medications. Both groups will be treated for 26 weeks. Participants will report to the study site for evaluations biweekly until week 10 and then monthly for the duration of the study. The following outcomes will be assessed at study entry and Week 26: insulin sensitivity, using an intravenous glucose tolerance test; visceral fat mass, using a CT scan; and total adiposity, using a dexascan.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338949
|United States, California|
|VA San Diego Healthcare System|
|San Diego, California, United States, 92161|
|Principal Investigator:||Jonathan M. Meyer, MD||University of California, San Diego & VA San Diego Healthcare System|