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Trial record 100 of 584 for:    ESCITALOPRAM

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

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ClinicalTrials.gov Identifier: NCT00550485
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Max-Planck-Institute of Psychiatry

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: escitalopram Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Blood-brain-barrier Permeability of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-gene: Effect on Sleep and Procedural Learning
Study Start Date : October 2007
Actual Primary Completion Date : July 6, 2018
Actual Study Completion Date : July 6, 2018

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Arm Intervention/treatment
1
Healthy subjects with a single nucleotide polymorphism (SNP) of the ABCB1-gene (Genotype A)
Drug: escitalopram
escitalopram 4 mg

2
Healthy subjects with a single nucleotide polymorphism (SNP) of the ABCB1-gene (Genotype B)
Drug: escitalopram
escitalopram 4 mg




Primary Outcome Measures :
  1. Time spent in rapid-eye-movement (REM) sleep assessed by polysomnography. [ Time Frame: after 6 days of intake of escitalopram ]
    Time spent in rapid-eye-movement (REM) sleep assessed by polysomnography.


Secondary Outcome Measures :
  1. Sleep stages [ Time Frame: after 6 days of intake of escitalopram ]
    Sleep stages beside REM sleep (wake, NonREM sleep) assessed by polysomnography

  2. Sleep continuity [ Time Frame: after 6 days of intake of escitalopram ]
    Sleep continuity measures assessed by polysomnography

  3. ABCB1 gene expression [ Time Frame: baseline and after 6 days of intake of escitalopram ]
    messenger ribonucleic acid (mRNA) expression of the target gene ABCB1

  4. Metabolic changes [ Time Frame: baseline and after 6 days of intake of escitalopram ]
    Small molecule metabolic changes in blood serum



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males 20-30 years

Exclusion Criteria:

  • any medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550485


Locations
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Germany
Max Planck Institute of Psychiatry
Munich, Germany, 81667
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
Investigators
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Principal Investigator: Axel Steiger, MD Max-Planck-Institute of Psychiatry

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Responsible Party: Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT00550485     History of Changes
Other Study ID Numbers: L3/2005
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents