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

Veterans Medical Research Foundation77 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia Metabolic Syndrome X Insulin Resistance

Interventions

SwitchDRUG

Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.

ControlDRUG

Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

VA San Diego Healthcare System

San Diego, California, United States

Outcomes

Primary Outcomes

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)

Time frame: Measured at Baseline and Week 26

Change in Visceral Fat Mass From Baseline to Week 26

CT measured change in visceral fat mass from baseline to week 26 (mm\^3)

Time frame: Baseline and Week 26

Data from ClinicalTrials.gov

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