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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00935246
Other study ID # 2008-12-042
Secondary ID
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


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
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