A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741026
• Other study ID #: 28230
• Status: Completed
• Phase: N/A
• First received: August 22, 2008
• Last updated: July 11, 2014
• Start date: August 2008
• Est. completion date: May 2011

Study information

• Verified date: July 2014
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Insulin Resistance

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	American Medical Association

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Leptin	Leptin following placebo or olanzapine treatment	3 Days	No
Primary	Oral Glucose Tolerance	Oral Glucose Tolerance	3 Days	No
Primary	Plasma Free Fatty Acid	Plasma Free Fatty Acid	3 Days	No
Secondary	HDL Cholesterol	HDL Cholesterol	3 Days	No
Secondary	Triglycerides	Triglycerides	3 Days	No
Secondary	LDL Cholesterol	LDL Cholesterol	3 Days	No
Secondary	Total Cholesterol	Total Cholesterol	3 Days	No
Secondary	Body Weight	Body Weight	3 Days	No
Secondary	BMI	BMI	3 Days	No
Secondary	Heart Rate	Heart Rate	3 Days	No
Secondary	Systolic Blood Pressure	Systolic Blood Pressure	3 Days	No
Secondary	Diastolic Blood Pressure	Diastolic Blood Pressure	3 Days	No