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

NCT ID: NCT00550485

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2018-07-06

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 (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.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

Healthy subjects with a single nucleotide polymorphism (SNP) of the ABCB1-gene (Genotype A)

Group Type: OTHER

escitalopram

Intervention Type: DRUG

escitalopram 4 mg

2

Healthy subjects with a single nucleotide polymorphism (SNP) of the ABCB1-gene (Genotype B)

Group Type: OTHER

escitalopram

Intervention Type: DRUG

escitalopram 4 mg

Interventions

escitalopram

escitalopram 4 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• healthy males 20-30 years

Exclusion Criteria

• any medication

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Max-Planck-Institute of Psychiatry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Axel Steiger, MD

Role: PRINCIPAL_INVESTIGATOR

Max-Planck-Institute of Psychiatry

Locations

Max Planck Institute of Psychiatry

Munich, , Germany

Countries

Germany

Other Identifiers

L3/2005

Identifier Type: -

Identifier Source: org_study_id