NCT00741026

A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers

A Double-blind, Placebo-controlled, Crossover Study Examining the Acute Effects of Olanzapine on Plasma Leptin, Glucose Tolerance and Free Fatty Acids in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical research study is to examine the acute hormonal and metabolic effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2) rapidly alters glucose tolerance in healthy volunteers. These questions will be answered by having volunteers undergo two glucose tolerance tests in a crossover study design.

Conditions

• Insulin Resistance
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Olanzapine 10 mg po qhs for 3 days	(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)
DRUG	Placebo	(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-12-01
• Completion: 2011-05-01
• First posted: 2008-08-25
• Last updated: 2014-07-14
• Results posted: 2014-07-14

Locations

1 site across 1 country: United States