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

NCT ID: NCT00338949

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-12-31

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 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.

Conditions

Schizophrenia; Metabolic Syndrome X; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Participants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DRUG

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

Switch

Participants who enter on risperidone or olanzapine and switch to ziprasidone

Group Type: EXPERIMENTAL

Switch

Intervention Type: DRUG

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

Interventions

Switch

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

Intervention Type: DRUG

Control

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

Intervention Type: DRUG

Other Intervention Names

ziprasidone; risperidone; olanzapine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Jonathan M. Meyer, MD

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan M. Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego & VA San Diego Healthcare System

Locations

VA San Diego Healthcare System

San Diego, California, United States

Countries

United States

References

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. doi: 10.1016/j.schres.2005.07.014. Epub 2005 Aug 30.

Reference Type: BACKGROUND

PMID: 16137860 (View on PubMed)

Other Identifiers

K23MH074540

Identifier Type: NIH

Identifier Source: secondary_id

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GA128029

Identifier Type: OTHER

Identifier Source: secondary_id

K23MH074540

Identifier Type: NIH

Identifier Source: org_study_id

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