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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00935246
• Other study ID #: 2008-12-042
• Status: Active, not recruiting
• Phase: N/A
• First received: July 7, 2009
• Last updated: December 30, 2015
• Start date: December 2008
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 202
• Est. completion date: December 2016
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 89 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Reaction to Drug
• Continuous Antidepressant Abuse
• Depression
• Drug-Related Side Effects and Adverse Reactions

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Kangnam	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	H. Lundbeck A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks		8 weeks	Yes
Secondary	biological value at 0 week and 8 weeks		8 weeks	Yes