|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 29, 2007 | ||||||||
| Last Updated Date | April 21, 2008 | ||||||||
| Start Date ICMJE | October 2007 | ||||||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Brain levels of escitalopram as assessed by a 19-F magnetic resonance spectroscopy [ Time Frame: after 6 takes of intake of escitalopram ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Brain levels of escitalopram as assessed by a 19-F magnetic resonance spectroscopy [ Time Frame: after 6 takes of intake of escitalopram ] | ||||||||
| Change History | Complete list of historical versions of study NCT00550485 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Sleep-EEG, functional MRI, learning, gene expression, metabolic changes [ Time Frame: after 6 days of intake of escitalopram ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Sleep-EEG, functional MRI, learning, gene expression, metabolic changes [ Time Frame: after 6 days of intake of escitalopram ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pharmacokinetic and Pharmacodynamic Effects of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-Gene | ||||||||
| Official Title ICMJE | Blood-Brain-Barrier Permeability of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-Gene: Effect on Sleep and Procedural Learning | ||||||||
| 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 CNS. 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. For determining intracerebral escitalopram levels, a 19-F magnetic resonance spectroscopy will be used. Sleep recordings are a useful bio-marker for effects of antidepressants on the CNS. Selective 5-HT1-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, there is good evidence that sleep is involved in various forms of memory processing. For example, it has been repeatedly shown that the performance in motor tasks (procedural learning) is correlated with the amount of stage 2 NonREM and REM sleep, respectively. Hence we hypothesize, that a drug-induced impairment of sleep (e. g. reduction of REM sleep) is associated with an impairment of procedural learning. In addition, effects of drug intake on the gene expression in lymphocytes and metabolic changes will be assessed. Functional magnetic resonance imaging will be applied to detect potential drug-induced changes of corticolimbic circuitries. |
||||||||
| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Basic Science, Open Label, Parallel Assignment | ||||||||
| Condition ICMJE | Pharmacokinetics | ||||||||
| Intervention ICMJE | Drug: escitalopram | ||||||||
| Study Arms / Comparison Groups |
|
||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | June 2009 | ||||||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Male | ||||||||
| Ages | 20 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00550485 | ||||||||
| Responsible Party | Axel Steiger, MD, Max-Planck-Institute of Psychiatry | ||||||||
| Study ID Numbers ICMJE | L3/2005 | ||||||||
| Study Sponsor ICMJE | Max-Planck-Institute of Psychiatry | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Max-Planck-Institute of Psychiatry | ||||||||
| Verification Date | April 2008 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
