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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00817375
Other study ID # 2003-01-12
Secondary ID
Status Recruiting
Phase N/A
First received January 5, 2009
Last updated December 30, 2015
Start date February 2003
Est. completion date December 2018

Study information

Verified date December 2015
Source Samsung Medical Center
Contact JungShil Back, B/Sc.
Phone 82-2-3410-0946
Email jungshil.back@sbri.co.kr
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.


Description:

The purpose of this study is

1. to determine whether genomic effects on antidepressant response differed by class of drug,

2. whether genomic differences between drug responders and nonresponders predict the response of antidepressant and

3. to construct the prediction model for antidepressant treatment in order to aid to select the their genetically matching drugs.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
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:
SSRI treated group
Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
non-SSRI treated group
Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks 6 weeks Yes
Secondary Biological value at 0 and 6 weeks 6weeks Yes
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