Ignite Creation Date:
2024-05-05 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00550485
Status:
COMPLETED
Last Update Posted:
2019-03-27
First Post:
2007-10-29
Brief Title:
Pharmacokinetic and Pharmacodynamic Effects of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-gene
Sponsor:
Max-Planck-Institute of Psychiatry
Organization:
Max-Planck-Institute of Psychiatry
Study Overview
Official Title:
Blood-brain-barrier Permeability of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-gene Effect on Sleep and Procedural Learning
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None