N/A
N=24
Metabolic Effects of Olanzapine in Healthy Males
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01496183 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Change From Baseline in Weight — 0.2; 1.7 Kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Olanzapine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weight |
0.2; 1.7 | — |
| SECONDARY Change From Baseline in Body Composition |
60.1; 65.8; 60.1; 67.0; 17.9; 16.5 | — |
| SECONDARY Change From Baseline in 24-Hour Dietary Recall |
1748; 2410; 1785; 2374 | — |
| SECONDARY Change From Baseline in Resting Metabolic Rate |
1702; 1855; 1689; 1858 | — |
| SECONDARY Change From Baseline Triglycerides |
48.4; 93.0; 52.8; 136.6 | — |
| SECONDARY Change From Baseline in Glucose |
82.4; 78.6; 85.0; 82.2 | — |
| SECONDARY Change From Baseline in Leptin |
3.8; 3.8; 4.8; 5.7 | — |
| SECONDARY Change From Baseline in Insulin |
5.0; 6.2; 5.8; 10.1 | — |
| SECONDARY Change From Baseline Total Cholesterol |
153.2; 156.8; 147.4; 167.0 | — |
| SECONDARY LDL |
88.8; 86.9; 82.0; 93.7 | — |
| SECONDARY HDL |
54.6; 51.3; 55.0; 46.1 | — |
| SECONDARY Physical Activity as Measured Using a Physical Activity Monitor |
410,029; 263,720; 279,722; 263,757; 279,149; 277,298 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01496183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.