Diabetes in Neuropsychiatric Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Trial Group<br>The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis. | Drug: Olanzapine<br>* 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.<br>* Other names: Zyprexa, Zydis, Relprevv;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | Baseline and 4 week intervals | 
| Fasting Glucose |  | Baseline and 4 week intervals | 
| Fasting Insulin |  | Baseline and 4 week intervals | 
| Hemoglobin A1c |  | Baseline and 4 week intervals | 
| IL-6 |  | Baseline and 4 week intervals | 
| Triglycerides |  | Baseline and 4 week intervals | 
| Cholesterol Total |  | Baseline and 4 week intervals | 
| HDL |  | Baseline and 4 week intervals | 
| LDL |  | Baseline and 4 week intervals | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Schizoaffective, psychosis, olanzapine