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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00006854 |
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Date of registration:
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14/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study on promotion of appetite after olanzapine in healthy volunteers
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Scientific title:
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Study on promotion of appetite after olanzapine in healthy volunteers - Olanzapine and appetite |
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Date of first enrolment:
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15/10/2014 |
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Target sample size:
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10 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00006854 |
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Study type:
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interventional |
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Study design:
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Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: basic science
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Phase:
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4
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Countries of recruitment
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Germany
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Contacts
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Name:
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Axel
Steiger |
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Address:
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Kraepelinstr. 2-10
80804
München
Germany |
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Telephone:
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08930622236 |
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Email:
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profsteiger@gmail.com |
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Affiliation:
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Max-Planck-Institut für Psychiatrie |
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Name:
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Axel
Steiger |
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Address:
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Kraepelinstr. 2 -10
80804
München
Germany |
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Telephone:
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08930622236 |
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Email:
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steiger@psych.mpg.de |
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Affiliation:
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Max-Planck-Institut für Psychiatrie |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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healthy volunteers
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Intervention(s)
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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 subject does not tolerate the dose of 10 mg
it will be reduced to 5 mg.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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2014-002682-30
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Source(s) of Monetary Support
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Max-Planck-Institut für Psychiatrie
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Ethics review
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Status: Approved
Approval date: 11/09/2014
Contact:
ethikkommission@med.uni-muenchen.de
Ethikkommission der Med. Fakultät der LMU
+49-89-440055191
ethikkommission@med.uni-muenchen.de
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