NCT00397059

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 6, 2008

Status Verified

February 1, 2008

Enrollment Period

10 months

First QC Date

November 6, 2006

Last Update Submit

February 5, 2008

Conditions

Healthy

Keywords

EscitalopramPharmacokineticsPharmacodynamicsCYP2C19Pupillometryhealthy volunteers

Outcome Measures

Primary Outcomes (3)

  • Dynamic pupillometry

  • Pharmacokinetics

  • AUC

Secondary Outcomes (3)

  • Cmax

  • Tmax

  • T½

Interventions

EscitalopramDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Drug or alcohol abuse
  • Allergy towards escitalopram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology, University of Southern Denmark

Odense, DK-5000, Denmark

Location

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kim Brosen, dr. med.

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2006

First Posted

November 8, 2006

Study Start

December 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

February 6, 2008

Record last verified: 2008-02

Locations

DK(1)