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

Schizophrenia Clinical Trial

Official title:

The Metabolic Syndrome in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338949
• Other study ID #: K23MH074540
• Secondary ID: K23MH074540GA128
• Status: Completed
• Phase: Phase 4
• Start date: June 2006
• Est. completion date: December 2009

Study information

• Verified date: October 2020
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 primary outcomes at Week 26 will be: change from baseline in insulin sensitivity, using an intravenous glucose tolerance test; change from baseline in ivisceral fat mass, using a CT scan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Schizophrenia
• Syndrome

Intervention

Drug:
• Switch
Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.
• Control
Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	National Institute of Mental Health (NIMH), Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

McEvoy JP, Meyer JM, Goff DC, Nasrallah HA, Davis SM, Sullivan L, Meltzer HY, Hsiao J, Scott Stroup T, Lieberman JA. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res. 2005 Dec 1;80(1):19-32. Epub 2005 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insulin Sensitivity Index From Baseline to Week 26 ((1/mU/L) x 1/Min)	As measured by frequently sampled intravenous glucose tolerance testing (units: 1/mU/L) x 1/Min)	Measured at Baseline and Week 26
Primary	Change in Visceral Fat Mass From Baseline to Week 26	CT measured change in visceral fat mass from baseline to week 26 (mm^3)	Baseline and Week 26