Status:
COMPLETED
Pfizer/IVGTT/Ziprasidone/Olanzapine
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Pfizer
Conditions:
Schizophrenia
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
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 commo...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00205725
Start Date
November 1 2000
End Date
October 1 2006
Last Update
March 13 2014
Active Locations (1)
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1
Washington University School of Medicine, Psychiatry Dept.
St Louis, Missouri, United States, 63110