NCT01119924已完成4 期
Phase IV Study for Evaluation the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of pain intensity using the visual analog scale (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Smilon® (Drug)
Placebo
Placebo Comparator
Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of pain intensity using the visual analog scale (VAS)
时间窗: 8-week treatment
次要结局
- 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)
研究者
研究点 (1)
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