Studies on permeability of the blood brain interface for escitalopramrelated to the genotype of the ABCB-1 gene -effects on sleep

Phase 4

• Conditions: healthy volunteers

• Registration Number: DRKS00006241
• Lead Sponsor: Max-Planck-Institut für Psychiatrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-12
• Study Completion: 2018-07-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Secondary objectives include to investigate whether in healthy subjects after treatment with the minimal REM sleep suppressing dosage of escitalopram for four days<br>•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,<br>•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,<br>•further SNPs characterizing the transporter proteins of the blood brain interface exerte influences on objective sleep variables,<br>•low molecular substances exert influences on objective sleep variables,<br>•plasma concentrations of escitalopram exert influences on objective sleep variables,<br>•the gene expression differs significantly from baseline.