Study on promotion of appetite after olanzapine in healthy volunteers
Phase 4
- Conditions
- healthy volunteers
- Registration Number
- DRKS00006854
- Lead Sponsor
- Max-Planck-Institut für Psychiatrie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 10
Inclusion Criteria
Healthy male volunteers. During the last 6 months
they should have regularly three meals per day.
Exclusion Criteria
• acute physical and psychiatric disorders
•psychiatric disorders in the own and family history
•any drug treatment exceeding two days during the last three months
and exceeding one day during the last month
•participation in another clincal trial at the same time or during the last
four weeks
•smoking
•monodirectional diets like vegetarian during the last six months
• chanfges of body weight, more than 2 kg during the last year
• high performance sport
•seriously defective vision
•intolerance to olanzapine or additives
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main objective of the trial is to investigate, whether in healthy<br>subjects the effect of pictures showing food on ghrelin plasma concentrations is more distinct after seven<br>days of treatment with olanzapine than at baseline, before treatment.
- Secondary Outcome Measures
Name Time Method Secondary objectives are to investigate wheter in healthy subjects<br>(i)the activity in the brain area subgenuale anterior cingulate cortex<br>(sgACC), measured during REM sleep by sLORETA differs after 7 days of<br>treatment with olanzpine from baseline conditions,<br>(ii)ghrelin plasma concentrations after showing neutral pictures differ from those after<br>showing pictures with food at baseline and after olanzapine as well,<br>(iii)plasma concentrations between 08:00 and 13:00 of ghrelin, leptin,<br>insulin, PYY and other substance invoved in metabolism differ between<br>baseline and 7 days of treatment with olanzapine <br>(iv)self rated appetite differs between baseline and 7 days of treatment<br>with olanzapine.