A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers
Information source: Penn State University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insulin Resistance; Diabetes Mellitus
Intervention: Olanzapine (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Penn State University Official(s) and/or principal investigator(s):
Ravi Singareddy, MD, Study Director, Affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Vance L Albaugh, B.S., Principal Investigator, Affiliation: Penn State College of Medicine
Overall contact:
Vance L Albaugh, B.S., Phone: 717-531-5344, Email: valbaugh@psu.edu
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.
Clinical Details
Official title: 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
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment
Primary outcome: Plasma Leptin
Secondary outcome: Glucose Tolerance
Eligibility
Minimum age: 18 Years.
Maximum age: 30 Years.
Gender(s): Both.
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
Locations and Contacts
Vance L Albaugh, B.S., Phone: 717-531-5344, Email: valbaugh@psu.edu
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Shirlynn M Mottilla, R.N., Phone: 717-531-5154, Email: smottill@gcrc.hmc.psu.edu
Vance L Albaugh, BS, Principal Investigator
Ravi Singareddy, MD, Sub-Investigator
Anoop Karippot, MD, Sub-Investigator
Christopher J Lynch, PhD, Sub-Investigator
Additional Information
Related publications: Albaugh VL, Henry CR, Bello NT, Hajnal A, Lynch SL, Halle B, Lynch CJ. Hormonal and metabolic effects of olanzapine and clozapine related to body weight in rodents. Obesity (Silver Spring). 2006 Jan;14(1):36-51.
Starting date: August 2008
Ending date: July 2009
Last updated: January 30, 2009
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