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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: |
DRKS00006241 |
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Date of registration:
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12/11/2014 |
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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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Studies on permeability of the blood brain interface for escitalopram
related to the genotype of the ABCB-1 gene -effects on sleep
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Scientific title:
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Studies on permeability of the blood brain interface for escitalopram
related to the genotype of the ABCB-1 gene -effects on sleep - Escitalopram and sleep |
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Date of first enrolment:
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07/11/2014 |
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Target sample size:
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27 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00006241 |
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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: Pharmacogenetics
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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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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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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1)Male healthy volunteers, 20 to 35 years old
2) each subject must understand the aims of the study and must give written informed consent
Exclusion criteria: 1) Participation in another study either at the same time or during the last month prior to entering the study,
2)Psychiatric disorder, acute or in the own history,
3) Sleep disorders, acute or during the last 3 months,
4) Nocturnal shift work during the last 3 months,
5) Transmeridian flight during the last 3 months,
6) Serious acute or chronic physical disorder,
7) Any drug intake lasting more than two days during the last 3 months, any drug intake during the last month
8) Smoking,
9) Use of alcohol, more than moderate,
10) more than 2 cups of coffee per day,
11) drug abuse during the last 4 months,
12) intolerance of escitaolpram or additives
Age minimum:
20 Years
Age maximum:
35 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 effect of escitalopram on sleep EEG is examined. First during phase A the minimal REM suppressing dosage is determined. In order to do this during four consecutive nights 2, 3, 4 and 5 mg escitalopram are given. In the main study (phase B) the effect of the dosage determined in phase A is given for four days in order to compare its effects in the genotypes CC or CT vs. TT on sleep EEG.
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Primary Outcome(s)
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The main objective is to investigate whether in healthy subjects who are carriers of the C/C or C/T genotype of the ABCB-1 gene, SNP rs2032583, the time spent in REM sleep is significantly less than in carriers of the T/T genotype after 4 days of treatment with escitalopram in the minimal dosage suppressing REM sleep as delineated by dose finding.
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Secondary Outcome(s)
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Secondary objectives include to investigate whether in healthy subjects after treatment with the minimal REM sleep suppressing dosage of escitalopram for four days
•further objective sleep variables [as the time spent in various sleep stages, sleep continuity, etc.] differs significantly from baseline [interval before tretament], indpendently from the genotype,
•those subjects who are carriers of the C/C or C/T genotype of the ABCB-1 gene show significantly more distinct changes of the objective sleep variables mentioned before than the carriers of the T/T genotype,
•further SNPs characterizing the transporter proteins of the blood brain interface exerte influences on objective sleep variables,
•low molecular substances exert influences on objective sleep variables,
•plasma concentrations of escitalopram exert influences on objective sleep variables,
•the gene expression differs significantly from baseline.
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Secondary ID(s)
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2014-001304-21
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Source(s) of Monetary Support
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Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V.
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Ethics review
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Status: Approved
Approval date: 25/08/2014
Contact:
ethikkommission@med.uni-muenchen.de
Ethikkommission der Med. Fakultät der LMU
+49-89-440055191
ethikkommission@med.uni-muenchen.de
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