Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype

Samsung Medical Center

Status: Unknown

Conditions: Depression

Treatments: Drug: responders; Drug: non-responders

Study type: Interventional

Funder types: Other

Identifiers

NCT01352559

2001-11-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 19 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

responders

Experimental group

Description:

50 ≤ Decrease rate(%) of HAM-D score

Treatment:

Drug: responders

non-responders

Active Comparator group

Description:

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

Treatment:

Drug: non-responders