Overview

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

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborator:
American Medical Association
Treatments:
Olanzapine
Criteria
Inclusion Criteria:

- Healthy Volunteer

- Body Mass Index of 18.5-25 kilograms per square meter

- Must be able to swallow tablets

- Able to give informed consent

Exclusion Criteria:

- Any DSM-IV TR Axis I psychiatric disorder (except nicotine dependence)

- Presence of any medical disorder that may confound the assessment of relevant biologic
measures, including: significant organ system dysfunction, metabolic diseases, type 1
diabetes mellitus, type 2 diabetes mellitus, pregnancy, endocrine disease,
coagulopathy, clinically significant anemia, or acute infection

- Subjects who have taken any antipsychotic medication within the last 6 months

- Personal or family history of seizures and/or cardiac arrhythmias