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

Not Applicable

• Conditions: Continuous Antidepressant Abuse; Adverse Reaction to Drug; Depression
• Interventions: Drug: Escitalopram

• Registration Number: NCT00935246
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Primary Completion: 2011-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2015-12-31
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antidepressant treated group	Escitalopram	Antidepressant treated group: depressed patients treated with Escitalopram

Primary Outcome Measures

Name	Time	Method
antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks	8 weeks

Secondary Outcome Measures

Name	Time	Method
biological value at 0 week and 8 weeks	8 weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Kangnam, Seoul, Korea, Republic of