Diabetes in Neuropsychiatric Disorders

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Schizophrenia

Treatments

Drug: Olanzapine

Study type

Interventional

Funder types

NIH

Identifiers

NCT00446992

HAC File#: 05-12-141

DK69265

Details and patient eligibility

About

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.

Full 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 these adverse effects.

Enrollment

30 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)