A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers
NCT ID: NCT00741026
Last Updated: 2014-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2008-08-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Placebo
Placebo
(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
Olanzapine
Olanzapine 10mg po daily x 3 days
Olanzapine 10 mg po qhs for 3 days
(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)
Interventions
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Olanzapine 10 mg po qhs for 3 days
(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)
Placebo
(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index of 18.5-25 kilograms per square meter
* Must be able to swallow tablets
* Able to give informed consent
Exclusion Criteria
* 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
18 Years
30 Years
ALL
Yes
Sponsors
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American Medical Association
OTHER
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Vance L. Albaugh
MD/PhD Student
Principal Investigators
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Ravi Singareddy, M.D.
Role: STUDY_DIRECTOR
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Vance L Albaugh, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine
Locations
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Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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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.
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. doi: 10.1038/mp.2010.33. 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. 2012 Jan;38(1):153-66. doi: 10.1093/schbul/sbq053. Epub 2010 May 21.
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. doi: 10.1371/journal.pone.0022662. Epub 2011 Aug 9.
Other Identifiers
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28230
Identifier Type: -
Identifier Source: org_study_id
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