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Pharmacokinetic and Pharmacodynamic Effects of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-gene

M

Max-Planck-Institute of Psychiatry

Status

Completed

Conditions

Pharmacokinetics

Treatments

Drug: escitalopram

Study type

Interventional

Funder types

Other

Identifiers

NCT00550485
L3/2005

Details and patient eligibility

About

The ABCB1-gene product P-glycoprotein is an integral membrane protein that actively transports substrates out of the intracellular compartment. One of the major sites of its action is the blood-brain-barrier. It is highly expressed in brain capillary endothelial cells and involved in limiting the access of substrates such as antidepressants to the central nervous system. A single nucleotide polymorphism (SNP) of the ABCB1-gene was recently identified showing a different treatment response to antidepressant drugs depending on the genotype. Therefore, it is assumed that healthy subjects with different genotypes of that SNP will be associated with significantly different brain levels of the antidepressant escitalopram after 6 days of intake. Sleep recordings are a useful bio-marker for effects of antidepressants on the CNS. Selective serotonin reuptake inhibitors (e.g. escitalopram) cause a suppression of REM sleep and a stronger fragmentation of sleep compared to untreated subjects. Higher plasma levels of antidepressants affected the sleep to a greater extent than lower levels. In line with this finding, we suppose that sleep EEG recordings of healthy subjects with different genotypes of the above mentioned SNP will be differently affected after taking 6 days escitalopram. In addition, effects of drug intake on the gene expression in lymphocytes and metabolic changes will be assessed.

Enrollment

79 patients

Sex

Male

Ages

20 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy males 20-30 years

Exclusion criteria

  • any medication

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

79 participants in 2 patient groups

1
Other group
Description:
Healthy subjects with a single nucleotide polymorphism (SNP) of the ABCB1-gene (Genotype A)
Treatment:
Drug: escitalopram
2
Other group
Description:
Healthy subjects with a single nucleotide polymorphism (SNP) of the ABCB1-gene (Genotype B)
Treatment:
Drug: escitalopram

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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