Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning
Information source: Samsung Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression; Antidepressant Response; Adverse Event
Intervention: Escitalopram (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Samsung Medical Center Official(s) and/or principal investigator(s):
Doh Kwan Kim, PhD, M.D., Principal Investigator, Affiliation: Samsung Medical Center
Overall contact:
Doh Kwan Kim, PhD., M.D., Phone: 82-2-3410-3582, Email: paulkim@skku.edu
Summary
To reveal the genetic determinants of the treatment outcome of escitalopram in depressed
patients (by using candidate gene approach and whole genome scanning).
Clinical Details
Official title: Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning
Study design: Treatment, Non-Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks
Secondary outcome: biological value at 0 week and 8 weeks
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
Eligibility
Minimum age: 19 Years.
Maximum age: 89 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Doh Kwan Kim, PhD., M.D., Phone: 82-2-3410-3582, Email: paulkim@skku.edu
Samsung Medical Center, #50 Ilwon-dong Kangnam-gu, Seoul 135-710, Korea, Republic of; Recruiting
Daemyoung Cha, Phone: 82-2-3410-2975, Email: daemyoung.cha@samsung.com
Additional Information
Starting date: December 2008
Ending date: January 2011
Last updated: July 14, 2009
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