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| Descriptive Information Fields | |||||||||
| Brief Title † | Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes | ||||||||
| Official Title † | The Metabolic Syndrome in Patients With Schizophrenia | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Insulin sensitivity [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ] Visceral fat mass [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ] Total adiposity [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Body mass index [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ] Fasting glucose [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ] Fasting lipids [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ] Fasting insulin [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ] Total psychiatric hospital days [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ] |
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| Condition † | Schizophrenia Metabolic Syndrome X Insulin Resistance |
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| Intervention † | Drug: Ziprasidone Drug: Standard atypical antipsychotic drug |
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| MEDLINE PMIDs | 16137860 | ||||||||
| Links | Click here for the Metabolic Research in Schizophrenia Laboratory website  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 77 | ||||||||
| Start Date † | June 2006 | ||||||||
| Completion Date | August 2010 | ||||||||
| 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 † | NCT00338949 | ||||||||
| Organization ID | K23 MH74540 | ||||||||
| Secondary IDs †† | DATR AK-TNET1 | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | June 16, 2006 | ||||||||
| Last Updated Date | February 27, 2008 | ||||||||
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