Metabolic Effects of Olanzapine in Healthy Males

• ClinicalTrials.gov Identifier: NCT01496183
• Recruitment Status: Completed
• First Posted: December 21, 2011
• Results First Posted: December 1, 2014
• Last Update Posted: August 16, 2018
• Sponsor: State University of New York at Buffalo
• Information provided by (Responsible Party): Steven Dubovsky, State University of New York at Buffalo

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Olanzapine; Drug: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Metabolic Effects of Olanzapine in Healthy Males
• Study Start Date: October 2007
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: April 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Weight [ Time Frame: Assessed at baseline and 2 weeks ]

Secondary Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, New York

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

Buffalo, New York, United States, 14215

Sponsors and Collaborators

State University of New York at Buffalo

Investigators

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

More Information

• Responsible Party: Steven Dubovsky, principal investigator, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT01496183
• Other Study ID Numbers: PCH0320106A
• First Posted: December 21, 2011
• Results First Posted: December 1, 2014
• Last Update Posted: August 16, 2018
• Last Verified: July 2018

Additional relevant MeSH terms:

Olanzapine; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents