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Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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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.

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.

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 ]
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 ]
Condition  Schizophrenia
Metabolic Syndrome X
Insulin Resistance
Intervention  Drug: Ziprasidone
Drug: Standard atypical antipsychotic drug
MEDLINE PMIDs 16137860
Links Click here for the Metabolic Research in Schizophrenia Laboratory website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  77
Start Date  June 2006
Completion Date August 2010
Eligibility Criteria 

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Currently receiving antipsychotic therapy with risperidone or olanzapine
  • Overweight

Exclusion Criteria:

  • Diagnosis of diabetes
  • Hospitalization for schizophrenia or schizoaffective disorder within 90 days prior to study entry
  • Refractory schizophrenia or schizoaffective disorder
  • Currently receiving therapy with clozapine
  • No stable residence and phone number for 90 days prior to study entry
  • Prior unsuccessful treatment with ziprasidone
  • Intolerance to ziprasidone
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Tanya Baker, BS     858-552-8585 ext 2875     tanyab@ucsd.edu    
Contact: Jonathan M. Meyer, MD     858-642-3570     jmmeyer@ucsd.edu    
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 
Principal Investigator:     Jonathan M. Meyer, MD     University of California, San Diego & VA San Diego Healthcare System    
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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