A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers
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
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
July 14, 2014
CompletedJuly 14, 2014
July 1, 2014
2.3 years
August 22, 2008
November 29, 2012
July 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Plasma Leptin
Leptin following placebo or olanzapine treatment
3 Days
Oral Glucose Tolerance
Oral Glucose Tolerance
3 Days
Plasma Free Fatty Acid
Plasma Free Fatty Acid
3 Days
Secondary Outcomes (9)
HDL Cholesterol
3 Days
Triglycerides
3 Days
LDL Cholesterol
3 Days
Total Cholesterol
3 Days
Body Weight
3 Days
- +4 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo
Olanzapine
EXPERIMENTALOlanzapine 10mg po daily x 3 days
Interventions
(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)
(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
Eligibility Criteria
You may qualify if:
- Healthy Volunteer
- Body Mass Index of 18.5-25 kilograms per square meter
- Must be able to swallow tablets
- Able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milton S. Hershey Medical Centerlead
- American Medical Associationcollaborator
Study Sites (1)
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Related Publications (4)
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. doi: 10.1038/oby.2006.6.
PMID: 16493121BACKGROUNDAlbaugh 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. doi: 10.1038/mp.2010.33. Epub 2010 Mar 23.
PMID: 20308992BACKGROUNDAlbaugh 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. 2012 Jan;38(1):153-66. doi: 10.1093/schbul/sbq053. Epub 2010 May 21.
PMID: 20494946BACKGROUNDAlbaugh 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. doi: 10.1371/journal.pone.0022662. Epub 2011 Aug 9.
PMID: 21857944RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
One episode of orthostatic hypotension requiring unblinding. One individual with emesis after glucose challenge and that individual's glucose tolerance data were unavailable analysis.
Results Point of Contact
- Title
- Vance L. Albaugh, Principle Investigator
- Organization
- American Medical Association
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD/PhD Student
Study Record Dates
First Submitted
August 22, 2008
First Posted
August 25, 2008
Study Start
August 1, 2008
Primary Completion
December 1, 2010
Study Completion
May 1, 2011
Last Updated
July 14, 2014
Results First Posted
July 14, 2014
Record last verified: 2014-07