Phase 2
N=30
Diabetes in Neuropsychiatric Disorders
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00446992 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Body Mass Index — 22.1; 23.5; 24.2; 24.3 kg/m^2 — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Olanzapine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Mass Index |
22.1; 23.5; 24.2; 24.3; 24.6 | <0.001 sig |
| PRIMARY Fasting Glucose |
82.1; 83.2; 86.0; 85.3; 89.1 | .043 sig |
| PRIMARY Fasting Insulin |
9.7; 12.1; 10.5; 11.1; 10.7 | = 0.690 |
| PRIMARY Hemoglobin A1c |
4.4; 4.4; 4.3; 4.4; 4.3 | = 0.691 |
| PRIMARY IL-6 |
3.5; 3.9; 6.4; 3.8; 2.3 | = 0.877 |
| PRIMARY Triglycerides |
80.1; 98.73; 107.2; 115.4; 113.47 | = 0.003 sig |
| PRIMARY Cholesterol Total |
163.2; 184.9; 186.5; 188.1; 188.1 | = .005 sig |
| PRIMARY HDL |
49.8; 50.1; 49.7; 49.7; 48.4 | = 0.696 |
| PRIMARY LDL |
96.6; 115.07; 116.0; 116.0; 117.7 | = 0.013 sig |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00446992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.