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

This study is currently recruiting participants.

Verified by Penn State University, January 2009

First Received: August 22, 2008 Last Updated: January 30, 2009 History of Changes

Sponsor:	Penn State University
Collaborator:	American Medical Association
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00741026

Purpose

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.

Condition	Intervention
Insulin Resistance Diabetes Mellitus	Drug: Olanzapine Drug: Placebo

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

Plasma Leptin [ Time Frame: 3 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glucose Tolerance [ Time Frame: 3 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
2: Experimental	Drug: Olanzapine (1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741026

Contacts

Contact: Vance L Albaugh, B.S.	717-531-5344	valbaugh@psu.edu
Contact: Shirlyn M Mottilla, R.N.	717-531-5154	smottill@gcrc.hmc.psu.edu

Locations

United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Shirlynn M Mottilla, R.N. 717-531-5154 smottill@gcrc.hmc.psu.edu
Principal Investigator: Vance L Albaugh, BS
Sub-Investigator: Ravi Singareddy, MD
Sub-Investigator: Anoop Karippot, MD
Sub-Investigator: Christopher J Lynch, PhD

Sponsors and Collaborators

Penn State University

American Medical Association

Investigators

Study Director:	Ravi Singareddy, MD	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Principal Investigator:	Vance L Albaugh, B.S.	Penn State College of Medicine

More Information

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.

Responsible Party:	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center ( Vance L. Albaugh )
Study ID Numbers:	28230
Study First Received:	August 22, 2008
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00741026 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Insulin Resistance
Diabetes mellitus
Antipsychotic

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Metabolic Diseases
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Diabetes Mellitus
Olanzapine
Antiemetics
Endocrine System Diseases

Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Hyperinsulinism
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Insulin Resistance
Glucose Metabolism Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010