NCT00446992

Diabetes in Neuropsychiatric Disorders

Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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 these adverse effects.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Olanzapine	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.

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-03-13
• Last updated: 2014-11-19
• Results posted: 2014-11-06

Locations

1 site across 1 country: Spain