Diabetes in Neuropsychiatric Disorders

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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 patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance with olanzapine treatment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Olanzapine

Criteria

• 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)