CompletedNCT02122939Updated Jun 3, 2014

A Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram in Elderly Volunteers

A Phase 1 interventional study of Escitalopram in Healthy, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-03.

Sponsored by Seoul National University Hospital · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 12
Allocation: Non-randomized
Ages: 65 Years and older
Sex: All

Study summary

An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the effect on ECG of escitalopram after oral administration in elderly volunteers.

Conditions studied

Healthy

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

healthy subject aged 65 or older at screening
A body weight in the range of 50 kg (inclusive) to 90 kg (inclusive) with BMI range of 19.0 to 28.0
subjects who decide to participate voluntarily and write a informed consent form

Exclusion criteria

Exclusion Criteria:

subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
Subject judged not eligible for study participation by investigator

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

Experimental
Escitalopram
Drug: Escitalopram

Interventions

DrugEscitalopram

What researchers measure

Primary outcomes

Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F
Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 32, 48 h post-dose

Secondary outcomes

QTc interval
Time frame: pre-dose, 1, 4, 6, 8, 12, 24, 28, 32, 48 h post-dose

Study locations

1 site

Seoul National University Bundang Hospital
Seongnam, Gyounggi, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02122939
Lead sponsor: Seoul National University Hospital
Responsible party: Jae Yong Chung (Associate professor, Seoul National University Bundang Hospital) — Principal investigator
First posted: Apr 25, 2014
Start date: Sep 2013
Primary completion: Mar 2014
Completion: Mar 2014
Last update: Jun 3, 2014

Study contacts

Jae-Yong Chung, MD, PhD

principal investigator · Seoul National University Bundang Hospital, Seongnam, Korea

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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