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

NCT00338949

Last updated date
Study Location
VA San Diego Healthcare System
San Diego, California, 92161, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Metabolic Syndrome X, Insulin Resistance
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of schizophrenia or schizoaffective disorder

- Currently receiving antipsychotic therapy with risperidone or olanzapine

- Overweight

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Schizophrenia, Metabolic Syndrome X, Insulin ResistanceZiprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes
NCT00338949
  1. San Diego, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Metabolic Syndrome X
  • Insulin Resistance
Intervention  ICMJE
  • 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.
    Other Name: ziprasidone
  • Drug: Control
    Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.
    Other Names:
    • risperidone
    • olanzapine
Study Arms  ICMJE
  • Active Comparator: Control
    Participants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone
    Intervention: Drug: Control
  • Experimental: Switch
    Participants who enter on risperidone or olanzapine and switch to ziprasidone
    Intervention: Drug: Switch
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2008)
77
Original Enrollment  ICMJE
 (submitted: June 16, 2006)
98
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00338949
Other Study ID Numbers  ICMJE K23MH074540( U.S. NIH Grant/Contract )
K23MH074540 ( U.S. NIH Grant/Contract )
GA128029 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Responsible Party Jonathan M. Meyer, MD, Veterans Medical Research Foundation
Study Sponsor  ICMJE Veterans Medical Research Foundation
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Jonathan M. Meyer, MDUniversity of California, San Diego & VA San Diego Healthcare System
PRS Account Veterans Medical Research Foundation
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP