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Completed

NCT Number: NCT00741026

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

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.

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Key information

Conditions

Insulin Resistance Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine 10 mg po qhs for 3 days

Drug

(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)

Other names: Zyprexa

Placebo

Drug

(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)

Other names: Sugar pill

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • American Medical Association

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Aug 25, 2008
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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