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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Olanzapine

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • Department of Psychiatry, The State University of New York at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo capsule administered orally at bedtime for 14 days
EXPERIMENTAL: Olanzapine	Drug: Olanzapine; Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory Breakfast Intake	Total kcal intake at breakfast in a laboratory setting at baseline and after 2 week of treatment with olanzapine or placebo	baseline and 2 week treatment

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Steven L Dubovsky, M.D., The State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 20, 2011
• First Posted (ESTIMATE): December 21, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: PCH0320106A