A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
- Study Primary Completion Date: December 2010
Intervention(s) in this Clinical Trial
- Drug: Olanzapine
- (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)
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: 1
- Experimental: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Plasma Leptin
- Time Frame: 3 Days
Safety Issue?: No
- Time Frame: 3 Days
- Plasma Leptin
- Time Frame: 3 days
Safety Issue?: No
- Time Frame: 3 days
Secondary Measures
- Glucose Tolerance
- Time Frame: 3 Days
Safety Issue?: No
- Time Frame: 3 Days
- Glucose Tolerance
- Time Frame: 3 days
Safety Issue?: No
- Time Frame: 3 days
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 30 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Penn State University Other
Overall Clinical Trial Officials and Contacts
Ravi Singareddy, M.D. Study Director Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Related Publications
References
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]
Citations Reporting Results
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00741026
Study ID Number: 28230
ClinicalTrials.gov Identifier: NCT00741026
Health Authority: United States: Institutional Review Board
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00741026
