Pfizer/IVGTT/Ziprasidone/Olanzapine
- Conditions
- Registration Number
- NCT00205725
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
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 al...
- Detailed Description
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 per...
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
-
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;
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meets DSM-IV criteria for Mental Retardation (mild or worse).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Effects of olanzapine/ziprasidone/haloperidol on glucose regulation
- Secondary Outcome Measures
Name Time Method Explore treatment-related effects on glucose effectiveness
Trial Locations
- Locations (1)
Washington University School of Medicine, Psychiatry Dept.
🇺🇸St. Louis, Missouri, United States