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OpenTrials
Completed

NCT Number: NCT01496183

Metabolic Effects of Olanzapine in Healthy Males

The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, The State University of New York at Buffalo

Buffalo, New York, 14215, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Volunteer
  • Male
  • Aged 18-35 years
  • Body Mass Index (BMI): <30 kg/m2

Exclusion criteria

  • Presence of any medical disorder that may confound the assessment of relevant biological measures

Treatment and study plan

Olanzapine

Drug

Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.

Placebo

Drug

Placebo capsule administered orally at bedtime for 14 days

Primary outcomes

  1. Change From Baseline in Weight

    Time frame: Assessed at baseline and 2 weeks

Secondary outcomes

  1. Change From Baseline in Body Composition

    Time frame: baseline and 2 weeks of treatment (olanzapine or placebo)

    lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo

  2. Change From Baseline in 24-Hour Dietary Recall

    Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)

    24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo

  3. Change From Baseline in Resting Metabolic Rate

    Time frame: baseline and 2weeks of treatment

    Resting metabolic rate at baseline and after 2 weeks of treatment

  4. Change From Baseline Triglycerides

    Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)

    Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo

  5. Change From Baseline in Glucose

    Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)

    Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo

  6. Change From Baseline in Leptin

    Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)

    Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo

  7. Change From Baseline in Insulin

    Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)

    Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo

  8. Change From Baseline Total Cholesterol

    Time frame: baseline and 2 weeks treatment

    Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo

  9. LDL

    Time frame: baseline and 2 weeks treatment

    Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo

  10. HDL

    Time frame: baseline and 2 weeks treatment

    High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo

  11. Physical Activity as Measured Using a Physical Activity Monitor

    Time frame: baseline and 2 week treatment

    Change from baseline in physical activity. Physical activity was measured using an activity monitor that subjects wore around their waist throughout baseline and treatment days. Subjects were instructed to remove the monitor when sleeping or engaging in water-based activities, and to report on a daily log the times that they were wearing and removing the device. Physical activity was monitored during weekdays and weekend days. Physical activity data were collected in 60-second epochs. The results are reported as average counts per day of physical activity for weekdays and weekend days at baseline and 2 week treatment.

Other outcomes

  1. Laboratory Breakfast Intake

    Time frame: baseline and 2 week treatment

    Total kcal intake at breakfast in a laboratory setting at baseline and after 2 week of treatment with olanzapine or placebo

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2011
Registry last updated
Aug 16, 2018

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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