Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Study Overview
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Brief Summary
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The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.

Detailed Description
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The difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) The time lag is existed until the patients respond to antidepressant and show the treatment effects. If it is predicted the response of antidepressant in advance, it would be overcome such problems. Drug response generally is known to be related to the individual genetic information and the environmental factors. We are going to investigation about antidepressant response using these approaches.

Official Title
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Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Conditions
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Depression, Antidepressant Drug Adverse Reaction

Intervention / Treatment
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* Drug: SSRI treated group
* Drug: non-SSRI treated group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 25 < age <85 major depressed patients satisfied with the diagnosis criteria depression of DSM-IV 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: 25 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSRI treated group<br>SSRI treated group are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline | Drug: SSRI treated group<br>* Antidepressant administration of SSRI class for 6 weeks under therapeutic dose<br>* Other names: citalopram_Celexa;|
| Active Comparator: non-SSRI treated group<br>non-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine | Drug: non-SSRI treated group<br>* Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose<br>* Other names: trazodone_Desyrel, Beneficat, Deprax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all pharmacogenetic and biological marker variables cause drug response |  | 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all clinical cause drug response |  | 24weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, pharmacogenomics, antidepressant response, biological markers, clinical variables