Metabolic Effects of Olanzapine in Healthy Males

Study Overview
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Brief Summary
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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.

Official Title
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Metabolic Effects of Olanzapine in Healthy Males

Conditions
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Healthy

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsule administered orally at bedtime for 14 days<br>|
| Experimental: Olanzapine<br> | Drug: Olanzapine<br>* Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Weight |  | Assessed at baseline and 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Body Composition | lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo | baseline and 2 weeks of treatment (olanzapine or placebo) | 
| Change From Baseline in 24-Hour Dietary Recall | 24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) | 
| Change From Baseline in Resting Metabolic Rate | Resting metabolic rate at baseline and after 2 weeks of treatment | baseline and 2weeks of treatment | 
| Change From Baseline Triglycerides | Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) | 
| Change From Baseline in Glucose | Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) | 
| Change From Baseline in Leptin | Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) | 
| Change From Baseline in Insulin | Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) | 
| Change From Baseline Total Cholesterol | Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo | baseline and 2 weeks treatment | 
| LDL | Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo | baseline and 2 weeks treatment | 
| HDL | High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo | baseline and 2 weeks treatment | 
| Physical Activity as Measured Using a Physical Activity Monitor | 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. | baseline and 2 week treatment |