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| Name | Class |
|---|---|
| Buddhist Tzu Chi General Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirtazapine | Active Comparator | 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 |
|
| Placebo | Placebo Comparator | Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smilon® | Drug | Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pain intensity using the visual analog scale (VAS) | 8-week treatment |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsai Hsin Chi | Buddhist Tzu Chi General Hospitsl | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nang Kuang Pharmaceutical Co., LTD | Tainan | Xinhua Township | Taiwan |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Placebo | Drug | Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks |
|
| 8-week treatment |
| Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire | 8-week treatment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |