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

NCT00741026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-07-14

Study results available
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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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Ravi Singareddy, M.D. · Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

  • Vance L Albaugh, M.D., Ph.D. · Penn State College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-12-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00741026 on ClinicalTrials.gov