Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4 6 weeks after drug administration, or represent the clinical status of depressed patients.

Detailed Description
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The purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.

Official Title
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Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

Conditions
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Depression

Intervention / Treatment
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* Drug: antidepressant response
* Drug: antidepressant non-response


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea. were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents Exclusion Criteria: pregnancy significant medical conditions abnormal laboratory baseline values unstable psychiatric features (e.g, suicidal attempt) history of alcohol or drug dependence, seizure, neurological illness, or concomitant Axis I psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: antidepressant response<br>antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score | Drug: antidepressant response<br>* Antidepressants administration for 6 weeks under therapeutic dose responders<br>* Other names: mirtazapine_Avanza, Zispin, Remeron;|
| Active Comparator: antidepressant non-response<br>antidepressant non-response are refered the patients having a 50 > Decrease rate(%) of HAM-D score | Drug: antidepressant non-response<br>* Antidepressants administration for 6 weeks under therapeutic dose nonresponders<br>* Other names: milnacipran, venlafaxine, nortriptyline, mirtazapine;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological value at 0 and 6 weeks | Biologial value is defined as protein expression value of signaling components in peripheral lymphocyte. Measurement value : Optical Density(O.D), microgram/liter(ug/l) | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antidepressant Response, Signal Transduction, Lymphocyte, Biomarkers, Depressed Patients, Antidepressant Drug Adverse Reaction