Clinical trial NCT00741026: A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Diabetes Mellitus
Keywords: Insulin Resistance
Diabetes mellitus
Antipsychotic
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: American Medical Association
First posted: 2008-08-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Plasma Leptin
timeFrame: 3 Days
measure: Oral Glucose Tolerance
timeFrame: 3 Days
measure: Plasma Free Fatty Acid
timeFrame: 3 Days
Secondary outcomes:
measure: HDL Cholesterol
timeFrame: 3 Days
measure: Triglycerides
timeFrame: 3 Days
measure: LDL Cholesterol
timeFrame: 3 Days
measure: Total Cholesterol
timeFrame: 3 Days
measure: Body Weight
timeFrame: 3 Days
measure: BMI
timeFrame: 3 Days
measure: Heart Rate
timeFrame: 3 Days
measure: Systolic Blood Pressure
timeFrame: 3 Days
measure: Diastolic Blood Pressure
timeFrame: 3 Days
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
name: Ravi Singareddy, M.D.
role: STUDY_DIRECTOR
affiliation: Penn State College of Medicine
name: Vance L Albaugh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.