CClinicalTrials.gg
Status unknownNCT00935246Updated Dec 31, 2015

Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning

An interventional study of Escitalopram in Depression, Continuous Antidepressant Abuse and Adverse Reaction to Drug, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 89 Years. Per ClinicalTrials.gov, last updated 2015-12-31.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
202
Allocation
Non-randomized
Ages
19 Years to 89 Years
Sex
All
01

Study summary

To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning).

Read the detailed description

The purposes of this study are:

  1. To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning)
  2. To improve the success rate of escitalopram treatment response for depressed patients
02

Conditions studied

  • Depression
  • Continuous Antidepressant Abuse
  • Adverse Reaction to Drug

Keywords

  • Genomic devices
  • Prediction of Escitalopram Response
  • Depressed Patients
03

In context

Drug-Related Side Effects and Adverse Reactions

437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.

This study's planned enrollment of 202 is above the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

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

04

Who can participate

Ages eligible
19 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
  2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion criteria

Exclusion Criteria:

  1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
  2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
202 participants (estimated)

Study arms

  • Experimental
    Antidepressant treated group

    Antidepressant treated group: depressed patients treated with Escitalopram

    Drug: Escitalopram

  • No intervention
    other antidepressant treated group

    other Antidepressant treated group: depressed patients treated with other antidepressant without escitalopram

Interventions

  • DrugEscitalopram

    Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose

    Also known as: Escitalopram : Lexapro

06

What researchers measure

Primary outcomes

  1. antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks

    Time frame: 8 weeks

Secondary outcomes

  1. biological value at 0 week and 8 weeks

    Time frame: 8 weeks

07

Study locations

1 site
  • Samsung Medical Center
    Kangnam, Seoul 135-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00935246
Lead sponsor
Samsung Medical Center
Collaborators
H. Lundbeck A/S
Responsible party
Doh Kwan Kim (M.D., Ph.D., Samsung Medical Center) — Principal investigator
First posted
Jul 8, 2009
Start date
Dec 2008
Primary completion
Oct 2011
Completion
Dec 2016 (estimated)
Last update
Dec 31, 2015

Study contacts

Doh Kwan Kim, PhD, M.D.
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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