Pupillary Changes as a Potential Biomarker for Escitalopr... | NCT00397059

Studies
Pupillary Changes as a Potential Biomarker for Escitalopram in Relation to CYP2C19 Polymorphism

NCT00397059

Sponsor

University of Southern Denmark

Status

Completed

Last Update Posted

Feb 6, 2008Estimated

Enrollment

16Estimated

Phase

Phase 4

Conditions

Healthy

Interventions

Escitalopram

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT no: 2006-001976-19

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Nov 6, 2006

First Submission Date that Met QC Criteria

Nov 7, 2006

First Posted Date

Nov 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2008

Last Update Posted Date

Feb 6, 2008Estimated

Name	Class
H. Lundbeck A/S	INDUSTRY

Description Module

Brief Summary

To study the impact of CYP2C19 polymorphism on escitalopram pharmacokinetics and pharmacodynamics measured as changes in pupil diameter

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dynamic pupillometry
Pharmacokinetics
AUC

Secondary Outcomes

Measure	Description	Time Frame
Cmax
Tmax
T½

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteer
Age: 18-45 years
Phenotyped for CYP2C19 activity

Exclusion Criteria:

Drug or alcohol abuse
Allergy towards escitalopram

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kim Brosen, dr. med.	University of Southern Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Pharmacology, University of Southern Denmark		Odense		DK-5000	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D000089983	Escitalopram

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

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