Metabolic Effects of Olanzapine in Healthy Males
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Oct 2007
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
December 1, 2014
CompletedAugust 16, 2018
July 1, 2018
5.5 years
December 13, 2011
November 24, 2014
July 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Weight
Assessed at baseline and 2 weeks
Secondary Outcomes (11)
Change From Baseline in Body Composition
baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in 24-Hour Dietary Recall
Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in Resting Metabolic Rate
baseline and 2weeks of treatment
Change From Baseline Triglycerides
Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in Glucose
Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
- +6 more secondary outcomes
Other Outcomes (1)
Laboratory Breakfast Intake
baseline and 2 week treatment
Study Arms (2)
Placebo
PLACEBO COMPARATOROlanzapine
EXPERIMENTALInterventions
Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Eligibility Criteria
You may qualify if:
- Healthy Volunteer
- Male
- Aged 18-35 years
- Body Mass Index (BMI): \<30 kg/m2
You may not qualify if:
- Presence of any medical disorder that may confound the assessment of relevant biological measures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, The State University of New York at Buffalo
Buffalo, New York, 14215, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The small sample size, the exclusion of obese subjects, and the short olanzapine exposure in the current study may limit the interpretation and generalizability of our findings.
Results Point of Contact
- Title
- Dr. Elsa Daurignac, Research Assistant Professor
- Organization
- The State University of New York at Buffalo
Study Officials
- PRINCIPAL INVESTIGATOR
Steven L Dubovsky, M.D.
State University of New York at Buffalo
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 21, 2011
Study Start
October 1, 2007
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
August 16, 2018
Results First Posted
December 1, 2014
Record last verified: 2018-07