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

Primary Purpose

Insulin Resistance, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Olanzapine 10 mg po qhs for 3 days
Placebo
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Insulin Resistance, Diabetes mellitus, Antipsychotic

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Olanzapine

Arm Description

Placebo

Olanzapine 10mg po daily x 3 days

Outcomes

Primary Outcome Measures

Plasma Leptin
Leptin following placebo or olanzapine treatment
Oral Glucose Tolerance
Oral Glucose Tolerance
Plasma Free Fatty Acid
Plasma Free Fatty Acid

Secondary Outcome Measures

HDL Cholesterol
HDL Cholesterol
Triglycerides
Triglycerides
LDL Cholesterol
LDL Cholesterol
Total Cholesterol
Total Cholesterol
Body Weight
Body Weight
BMI
BMI
Heart Rate
Heart Rate
Systolic Blood Pressure
Systolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure

Full Information

First Posted
August 22, 2008
Last Updated
July 11, 2014
Sponsor
Milton S. Hershey Medical Center
Collaborators
American Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT00741026
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
American Medical Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Diabetes Mellitus
Keywords
Insulin Resistance, Diabetes mellitus, Antipsychotic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
Olanzapine 10mg po daily x 3 days
Intervention Type
Drug
Intervention Name(s)
Olanzapine 10 mg po qhs for 3 days
Other Intervention Name(s)
Zyprexa
Intervention Description
(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
Primary Outcome Measure Information:
Title
Plasma Leptin
Description
Leptin following placebo or olanzapine treatment
Time Frame
3 Days
Title
Oral Glucose Tolerance
Description
Oral Glucose Tolerance
Time Frame
3 Days
Title
Plasma Free Fatty Acid
Description
Plasma Free Fatty Acid
Time Frame
3 Days
Secondary Outcome Measure Information:
Title
HDL Cholesterol
Description
HDL Cholesterol
Time Frame
3 Days
Title
Triglycerides
Description
Triglycerides
Time Frame
3 Days
Title
LDL Cholesterol
Description
LDL Cholesterol
Time Frame
3 Days
Title
Total Cholesterol
Description
Total Cholesterol
Time Frame
3 Days
Title
Body Weight
Description
Body Weight
Time Frame
3 Days
Title
BMI
Description
BMI
Time Frame
3 Days
Title
Heart Rate
Description
Heart Rate
Time Frame
3 Days
Title
Systolic Blood Pressure
Description
Systolic Blood Pressure
Time Frame
3 Days
Title
Diastolic Blood Pressure
Description
Diastolic Blood Pressure
Time Frame
3 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Singareddy, M.D.
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vance L Albaugh, M.D., Ph.D.
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16493121
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.
Results Reference
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PubMed Identifier
20308992
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.
Results Reference
background
PubMed Identifier
20494946
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.
Results Reference
background
PubMed Identifier
21857944
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.
Results Reference
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A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers

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