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| Sponsors and Collaborators: |
University of Southern Denmark H. Lundbeck A/S |
|---|---|
| Information provided by: | University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT00397059 |
Purpose
To study the impact of CYP2C19 polymorphism on escitalopram pharmacokinetics and pharmacodynamics measured as changes in pupil diameter
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Escitalopram |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Pupillary Changes as a Potential Biomarker for Escitalopram in Relation to CYP2C19 Polymorphism |
| Estimated Enrollment: | 16 |
| Study Start Date: | December 2006 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Escitalopram, the therapeutic active S-enantiomer of citalopram, is a selective serotonine reuptake inhibitor (SSRI) used for treatment of depression and anxiety disorders. The antidepressant effect is probably due to a stimulation of the serotonergic neurotransmission caused by the inhibition of the presynaptic serotonin reuptake. This inhibition may also be responsible for the increased pupil diameter seen in volunteers treated with racemic citalopram. Based on escitaloprams pharmacodynamic properties it is expected to have the same affect on pupil diameter. A dose/response relationship has not yet been established but theoretically the pupillary changes might serve as a biomarker for the serotonergic effect of escitalopram.
Escitalopram is demethylated in part by the polymorphic cytochrome P450 enzyme 2C19 (CYP2C19); but the impact of CYP2C19 polymorphism on the total metabolism of escitalopram is still to be investigated.
Objective: The aim of this study is to investigate the pharmacokinetics and pharmacodynamics in CYP2C19 extensive metabolizers (EMs) and poor metabolizers (PMs) and to investigate whether change in pupil size reaction to a light stimulus can act as a biomarker for the serotonergic effect of escitalopram.
The study will be conducted as a randomized, double blinded; placebo controlled two phases cross-over trial with single and repeated doses of 20 mg escitalopram and equivalent placebo. Sixteen healthy volunteers (8 EMs and 8 PMs) will participate in the trial. Prior to the trial, approximately 400 volunteers will be phenotyped by omeprazole metabolic ratio in order to identify the CYP2C19 EMs and PMs.
During the two phases blood samples will be drawn and pupil sizes will be measured at fixed time points after drug administration.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Clinical Pharmacology, University of Southern Denmark | |
| Odense, Denmark, DK-5000 | |
| Principal Investigator: | Kim Brosen, dr. med. | University of Southern Denmark |
More Information
| Study ID Numbers: | AKF-371, EudraCT no: 2006-001976-19 |
| Study First Received: | November 6, 2006 |
| Last Updated: | February 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00397059 |
| Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics |
|
Escitalopram Pharmacokinetics Pharmacodynamics |
CYP2C19 Pupillometry healthy volunteers |
|
Healthy Dexetimide Citalopram Serotonin |
|
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |
