A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers - Full Text View

Sponsor:	Penn State University
Collaborator:	American Medical Association
Information provided by (Responsible Party):	Vance L. Albaugh, 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:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines

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 ]
Leptin following placebo treatment
Plasma Leptin [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Leptin following olanzapine treatment

Secondary Outcome Measures:

Glucose Tolerance [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
Oral Glucose Tolerance following placebo treatment
Glucose Tolerance [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Oral Glucose Tolerance following olanzapine treatment

Enrollment:	15
Study Start Date:	August 2008
Study Completion Date:	May 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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

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

Locations

United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Penn State University

American Medical Association

Investigators

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

More Information

Publications:

Albaugh VL, Singareddy R, Mauger D, Lynch CJ. A double blind, placebo-controlled, randomized crossover study of the acute metabolic effects of olanzapine in healthy volunteers. PLoS One. 2011;6(8):e22662. Epub 2011 Aug 9.

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.

Albaugh VL, Judson JG, She P, Lang CH, Maresca KP, Joyal JL, Lynch CJ. Olanzapine promotes fat accumulation in male rats by decreasing physical activity, repartitioning energy and increasing adipose tissue lipogenesis while impairing lipolysis. Mol Psychiatry. 2011 May;16(5):569-81. Epub 2010 Mar 23.

Albaugh VL, Vary TC, Ilkayeva O, Wenner BR, Maresca KP, Joyal JL, Breazeale S, Elich TD, Lang CH, Lynch CJ. Atypical Antipsychotics Rapidly and Inappropriately Switch Peripheral Fuel Utilization to Lipids, Impairing Metabolic Flexibility in Rodents. Schizophr Bull. 2010 May 21; [Epub ahead of print]

Responsible Party:	Vance L. Albaugh, MD/PhD Student, Penn State University
ClinicalTrials.gov Identifier:	NCT00741026 History of Changes
Other Study ID Numbers:	28230
Study First Received:	August 22, 2008
Last Updated:	October 31, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Insulin Resistance
Diabetes mellitus
Antipsychotic

Additional relevant MeSH terms:

Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012