Status:
COMPLETED
Diabetes in Neuropsychiatric Disorders
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis. We hypothesize that in drug-naive patie...
Detailed Description
Antipsychotic medications are associated with an increased risk of diabetes. We focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict the...
Eligibility Criteria
Inclusion
- Age 18-64
- Maximum cumulative (lifetime) antipsychotic exposure of one week, and no antipsychotic use in the previous 30 days before enrolling in the study
- No history of diabetes or other serious medical or neurological condition associated with glucose intolerance or insulin resistance (eg, Cushing disease),
- Not taking a medication associated with insulin resistance (eg, hydrochlorothiazide, furosemide, ethacrynic acid, metolazone, chlorthalidone), beta blockers, glucocorticoids, phenytoin, nicotinic acid, cyclosporine, pentamidine, or narcotics)
- No history of cocaine use in the previous 30 days, and
- No laboratory evidence of diabetes at baseline (fasting glucose \<126 mg/dL or 2-hour glucose \<200 mg/dL on a glucose tolerance test)
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00446992
Start Date
April 1 2006
End Date
March 1 2010
Last Update
November 19 2014
Active Locations (1)
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1
Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170
Barcelona, Spain, 08036