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Pfizer/IVGTT/Ziprasidone/Olanzapine

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00205725
First received: September 13, 2005
Last updated: March 12, 2014
Last verified: March 2014

September 13, 2005
March 12, 2014
November 2000
October 2006   (final data collection date for primary outcome measure)
Effects of olanzapine/ziprasidone/haloperidol on glucose regulation
Same as current
Complete list of historical versions of study NCT00205725 on ClinicalTrials.gov Archive Site
Explore treatment-related effects on glucose effectiveness
Same as current
Not Provided
Not Provided
 
Pfizer/IVGTT/Ziprasidone/Olanzapine
Glucose Regulation During Ziprasidone Treatment

Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in individuals with schizophrenia than in healthy subjects or in other psychiatric conditions. Antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Hyperglycemia can contribute to long-term cardiovascular disease risk that may already be increased in patients with schizophrenia due to higher rates of smoking, sedentary life style, obesity and under-treated hypertension and dyslipidemia. This project will characterize the effects on glucose control of the two most commonly prescribed newer antipsychotic medications, ziprasidone and olanzapine, in patients with schizophrenia.

This proposal aims to use a well-characterized procedure, the modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT), to characterize the glucoregulatory effects of the two most commonly prescribed atypical antipsychotic medications, ziprasidone and olanzapine, in comparison to the conventional antipsychotic haloperidol. Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in individuals with schizophrenia than in healthy subjects or in other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia prior to the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation.

Recently, the adverse effect of antipsychotic medications on systemic glucose regulation has received increased attention as investigators noted prominent adverse glucoregulatory effects associated with certain newer antipsychotic medications. Abnormal glucose regulation and new-onset type 2 diabetes have been reported during clozapine and olanzapine treatment. Complicating the study of antipsychotic-induced changes in glucose regulation, increased adiposity can decrease insulin sensitivity, and antipsychotics can increase adiposity and body mass index (BMI). However, abnormal glucose regulation and type 2 diabetes can occur during clozapine treatment in the absence of weight gain, suggesting that changes in glucose regulation can occur independent of drug-induced increases in BMI. Consistent with this, our preliminary studies indicate that important effects of clozapine and olanzapine on glucose regulation are not accounted for by differences in BMI. This proposal will compare the effects of olanzapine, ziprasidone and haloperidol on well-defined measures of glucose regulation.

This proposal specifically hypothesizes that olanzapine treatment will be associated with decreases in insulin sensitivity (SI), without effects on insulin secretion. Treatment-related effects on glucose effectiveness (SG) will be explored.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Type 2 Diabetes Mellitus
Drug: Ziprasidone, Olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
October 2006
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients: meets DSM-IV criteria for schizophrenia, any type, or schizoaffective disorder;
  • aged 18 to 60 years;
  • able to give informed consent;
  • no medication changes for 2 weeks prior to and during the period of study;
  • Patients: currently taking an antipsychotic.

Exclusion Criteria:

  • Controls: Axis I psychiatric disorder criteria met except for substance use disorders as below;
  • meets DSM-IV criteria for the diagnoses of substance abuse or dependence within the past six months;
  • involuntary legal status (as per Missouri law);
  • the presence of any serious medical disorder that may (as confirmed by peer-reviewed literature) confound the assessment of symptoms, relevant biologic measures or diagnosis;
  • the following conditions are currently identified:

    • insulin- or non-insulin-dependent diabetes mellitus;
    • any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months;
    • any diagnosed cardiac condition causing documented hemodynamic compromise;
    • any diagnosed respiratory condition causing documented or clinically recognized hypoxia;
    • pregnancy or high dose estrogens, fever, narcotic therapy, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, dehydration, epilepsy, endocrine disease, high-dose benzodiazepine therapy (> 25 mg/day of diazepam), or any medical condition known to interfere with glucose utilization;
  • meets DSM-IV criteria for Mental Retardation (mild or worse).
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205725
Pfizer IVGTT/941273
No
Washington University School of Medicine
Washington University School of Medicine
Pfizer
Principal Investigator: John W. Newcomer, M.D. Washington University School of Medicine and Florida Atlantic University
Washington University School of Medicine
March 2014

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