Effects on sleep electroencephalogram and motoric learning in healthy volunteers related to the permeability of the blood-brain-barrier related to genotypes of the ABCB 1 gene
Conditions
Interventions
Trade Name: Cipralex 10 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Escitalopram oxalate
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentr
Sponsors
Max Planck Institute of Psychiatry
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: healthy male volunteers, 20 to 30, or 50 to 60 years old, genotype A/A or B/B of the ABCB1 gene, capable to perform all tests and examinations, capable to understand the aims of the study, written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: participation in another trial during the last month, psychiatric disorders, present or during life time, sleep disorders present or during the last 3 months, night work or transmeridian flight during the last 3 months, serious somatic disorders, intake of drugs during more than 2 days during the last 3 months, any drug intake during the last month, smoker, abuse of alcohol, more than 2 cups coffee per day, recreational drugs during the last 4 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether in healthy volunteers with the genotype A/A of the ABCB1 gene the brain concentration of escitaloprame as assessed by 19-fluor-magnetic-resonance spectroscopy is significantly lower than in subjects with the genotype B/B;Primary end point(s): escitaloprame brain and serum concentrations, sleep EEG motoric learning ;Secondary Objective: To test- whether sleep electroencephalogram (EEG) variables differ after 6 days treatment with escitaloprame significantly versus baseline (before treatment), -whether sleep-EEG variables of healthy volunteers with genotypes A/A versus B/B of the ABCB1 gene differ after 6 days treament with escitaloprame, -whether motoric learning assessed by the finger tapping task differs in the subjects after 6 days treatment with escitaloprame compared to baseline, -whether motoric learning differs between subjects with genotypes A/A and B/B after 6 days treatment with escitaloprame, -whether the concentrations of escitaloprame in the brain, assessed by 19-fluor-magnetic-resonance spectroscopy correlate with the serum concentrations of the substance, -whether there are significant differences of these effects in subjects 20 to 30 years, and 50 to 60 years old, respectively. | — |
Countries
Germany
Outcome results
None listed