healthy volunteers
Conditions
Interventions
Group 1: The subjects receive during seven days at 20:00 Olanzapin (Zyprexa ®) orally as a pill. Tehe dosages are
at Days 1 and 2: 2.5 mg,
at Days 3 and 4: 5.0 mg,
at Days 5 bto 7: 10,0 mg.
If a su
Sponsors
Max-Planck-Institut für Psychiatrie
Eligibility
Sex/Gender
Male
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: Healthy male volunteers. During the last 6 months they should have regularly three meals per day.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of the trial is to investigate, whether in healthy subjects the effect of pictures showing food on ghrelin plasma concentrations is more distinct after seven days of treatment with olanzapine than at baseline, before treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to investigate wheter in healthy subjects (i)the activity in the brain area subgenuale anterior cingulate cortex (sgACC), measured during REM sleep by sLORETA differs after 7 days of treatment with olanzpine from baseline conditions, (ii)ghrelin plasma concentrations after showing neutral pictures differ from those after showing pictures with food at baseline and after olanzapine as well, (iii)plasma concentrations between 08:00 and 13:00 of ghrelin, leptin, insulin, PYY and other substance invoved in metabolism differ between baseline and 7 days of treatment with olanzapine (iv)self rated appetite differs between baseline and 7 days of treatment with olanzapine. | — |
Countries
Germany
Contacts
Public ContactAxel Steiger
Max-Planck-Institut für Psychiatrie
Outcome results
None listed