Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Drug: responders
* Drug: non-responders


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: responders<br>50 ≤ Decrease rate(%) of HAM-D score | Drug: responders<br>* Antidepressants administration for 6 weeks under therapeutic dose<br>* Other names: mirtazapine_Avanza, Zispin, Remeron;|
| Active Comparator: non-responders<br>nonresponders is a patients having 50 > Decrease rate(%) of HAM-D score | Drug: non-responders<br>* Antidepressants administration for 6 weeks under therapeutic dose<br>* Other names: SSRI nonresponders;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antidepressant Response at 6 weeks | antidepressant response is defined as the decrease rate of HAM-D score for 6week was = or > 50% Measurement Unit = responders, nonresponders | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological value at 0 and 6 weeks | Biological value is defined as Genetic information of bioamine transporter genes of patients. Measurement unit = if it is SNP,it is A, T, G, or C, and if VNTR, short or long allele or Biological measure value of patients at 0 and 6week after antidepressant treatment(ex. peripheral markers such as serum BDNF, CREB...). Measurement unit = numerical value and thier unit such as O.D.(Optical Density) | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacogenomics, Prediction of Antidepressant Response, Depressed Patients, biomarkers, phenotype, Antidepressant Response, Adverse Reaction to Drug