Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether pharmacogenetic study predict Mirtazapine responsiveness in advance before the appearance of the drug effect until 4-6 weeks after administration of Mirtazapine.

Detailed Description
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The purpose of this study is to determine whether genomic differences between drug responders and nonresponders predict the response of Mirtazapine and to construct the prediction model for Mirtazapine treatment in depressed patients in order to aid to select the genetically matching drug.

Official Title
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Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Conditions
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Depression

Intervention / Treatment
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* Drug: Mirtazapine


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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No

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Responders<br>Reponders is a patients group who showed 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine | Drug: Mirtazapine<br>* Mirtazapine administration for 6 weeks under therapeutic dose<br>* Other names: Mirtazapine_Remeron, Avanza, Zispin;|
| Experimental: Non-responders<br>Non-responders is a patients group who did not show 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine | Drug: Mirtazapine<br>* Mirtazapine administration for 6 weeks under therapeutic dose<br>* Other names: Mirtazapine_Remeron, Avanza, Zispin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mirtazapine response at 2,4,6 weeks and adverse events (A/E) monitoring at 1,2,4,6 weeks |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological value at 0 and 6 weeks |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacogenomics, Prediction of Mirtazapine response, Depressed patients, Mirtazapine response, Adverse event