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

This study has been completed.
Sponsor:
Collaborator:
American Medical Association
Information provided by (Responsible Party):
Vance L. Albaugh, Penn State University
ClinicalTrials.gov Identifier:
NCT00741026
First received: August 22, 2008
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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 Intervention
Insulin Resistance
Diabetes Mellitus
Drug: Olanzapine 10 mg po qhs for 3 days
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Plasma Leptin [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    Leptin following placebo or olanzapine treatment

  • Oral Glucose Tolerance [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    Oral Glucose Tolerance

  • Plasma Free Fatty Acid [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    Plasma Free Fatty Acid


Secondary Outcome Measures:
  • HDL Cholesterol [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    HDL Cholesterol

  • Triglycerides [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    Triglycerides

  • LDL Cholesterol [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    LDL Cholesterol

  • Total Cholesterol [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    Total Cholesterol

  • Body Weight [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    Body Weight

  • BMI [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    BMI

  • Heart Rate [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    Heart Rate

  • Systolic Blood Pressure [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    Systolic Blood Pressure

  • Diastolic Blood Pressure [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    Diastolic Blood Pressure


Enrollment: 15
Study Start Date: August 2008
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Vance L. Albaugh, MD/PhD Student, Penn State University
ClinicalTrials.gov Identifier: NCT00741026     History of Changes
Other Study ID Numbers: 28230
Study First Received: August 22, 2008
Results First Received: November 29, 2012
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on September 18, 2014