Official Title: “Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2010

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

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Antidepressant treated group
  • Antidepressant treated group: depressed patients treated with Escitalopram

Primary Measures

• antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks
  • Time Frame: 8 weeks
    Safety Issue?: Yes

Secondary Measures

• biological value at 0 week and 8 weeks
  • Time Frame: 8 weeks
    Safety Issue?: Yes

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:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 89 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Samsung Medical Center

Overall Clinical Trial Officials and Contacts

Doh Kwan Kim, PhD, M.D. Principal Investigator Samsung Medical Center  

Overall Contact: Doh Kwan Kim, PhD., M.D. 82-2-3410-3582 paulkim@skku.edu

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00935246

Study ID Number: 2008-12-042

ClinicalTrials.gov Identifier: NCT00935246

Health Authority: South Korea: Institutional Review Board