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

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ClinicalTrials.gov Identifier: NCT00741026
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Collaborator:
American Medical Association
Information provided by (Responsible Party):
Vance L. Albaugh, Penn State University

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Diabetes Mellitus Drug: Olanzapine 10 mg po qhs for 3 days Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
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 Start Date : August 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
Other Name: Sugar pill
Experimental: Olanzapine
Olanzapine 10mg po daily x 3 days
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)
Other Name: Zyprexa



Primary Outcome Measures :
  1. Plasma Leptin [ Time Frame: 3 Days ]
    Leptin following placebo or olanzapine treatment

  2. Oral Glucose Tolerance [ Time Frame: 3 Days ]
    Oral Glucose Tolerance

  3. Plasma Free Fatty Acid [ Time Frame: 3 Days ]
    Plasma Free Fatty Acid


Secondary Outcome Measures :
  1. HDL Cholesterol [ Time Frame: 3 Days ]
    HDL Cholesterol

  2. Triglycerides [ Time Frame: 3 Days ]
    Triglycerides

  3. LDL Cholesterol [ Time Frame: 3 Days ]
    LDL Cholesterol

  4. Total Cholesterol [ Time Frame: 3 Days ]
    Total Cholesterol

  5. Body Weight [ Time Frame: 3 Days ]
    Body Weight

  6. BMI [ Time Frame: 3 Days ]
    BMI

  7. Heart Rate [ Time Frame: 3 Days ]
    Heart Rate

  8. Systolic Blood Pressure [ Time Frame: 3 Days ]
    Systolic Blood Pressure

  9. Diastolic Blood Pressure [ Time Frame: 3 Days ]
    Diastolic Blood Pressure



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741026


Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
American Medical Association
Investigators
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

Publications of Results:
Other Publications:
Responsible Party: Vance L. Albaugh, MD/PhD Student, Penn State University
ClinicalTrials.gov Identifier: NCT00741026     History of Changes
Other Study ID Numbers: 28230
First Posted: August 25, 2008    Key Record Dates
Results First Posted: July 14, 2014
Last Update Posted: July 14, 2014
Last Verified: July 2014

Keywords provided by Vance L. Albaugh, Penn State University:
Insulin Resistance
Diabetes mellitus
Antipsychotic

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents