A Clinical Study for Assessment of the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Efficacy and Safety of Smilon® in the Depression Patients with pain. Eligible patients will be randomly assigned to 1 of 2 arms, either Smilon® or placebo, and will receive the treatment for 8 weeks in this study.

Official Title
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Phase IV Study for Evaluation the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain

Conditions
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Depression, Pain

Intervention / Treatment
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* Drug: Smilon®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age 20-65 years Diagnosis of at least one chronic pain syndrome and the diagnosis of concomitant depression according to DSM-IV criteria Have a mean weekly pain score of at least 30 mm on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) before study entry Exclusion Criteria: Women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives Known hypersensitivity to Mirtazapine or any of its components Subjects who have a clinically significant or unstable medical or psychiatric condition Subjects who have received nerve blocks or acupuncture for pain relief

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mirtazapine<br>Mirtazapine 15mg/day or placebo once a day on the fist week, then 30 mg/day or placebo once a day, and then for 7 consecutive weeks | Drug: Smilon®<br>* Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks<br>|
| Placebo Comparator: Placebo<br>Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks | Drug: Placebo<br>* Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pain intensity using the visual analog scale (VAS) |  | 8-week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS) |  | 8-week treatment | 
| Evaluation of Severity of depressive and anxious symptom using the Hamilton depression scale (HAM-D) and Hamilton anxiety scale (HAM-A) |  | 8-week treatment | 
| Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire |  | 8-week treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mirtazapine, Smilon, Depression, Pain