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Clinical Trials/NCT01352559
NCT01352559
Unknown
Not Applicable

Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype

Samsung Medical Center1 site in 1 country1,000 target enrollmentNovember 2001

Overview

Phase
Not Applicable
Intervention
responders
Conditions
Depression
Sponsor
Samsung Medical Center
Enrollment
1000
Locations
1
Primary Endpoint
Antidepressant Response at 6 weeks
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to determine whether pharmacogenomic study of bioamine transporters and peripheral lymphatic biomarkers(phenotype) predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.

Detailed Description

The purpose of this study is to determine whether genomic effects or peripheral lymphatic biomarkers on antidepressant response differed by class of drug, whether genomic and biomarker differences between drug responders and nonresponders predict the response of antidepressant and to construct the prediction model for antidepressant treatment in order to aid to select the their genetically or endophenotypic matching drugs.

Registry
clinicaltrials.gov
Start Date
November 2001
End Date
December 2018
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Doh Kwan Kim

M.D., pHD

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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.
  • interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria

  • received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
  • 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.

Arms & Interventions

responders

50 ≤ Decrease rate(%) of HAM-D score

Intervention: responders

non-responders

nonresponders is a patients having 50 \> Decrease rate(%) of HAM-D score

Intervention: non-responders

Outcomes

Primary Outcomes

Antidepressant Response at 6 weeks

Time Frame: 6 weeks

antidepressant response is defined as the decrease rate of HAM-D score for 6week was = or \> 50% Measurement Unit = responders, nonresponders

Secondary Outcomes

  • Biological value at 0 and 6 weeks(6 weeks)

Study Sites (1)

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