Efficacy of Antidepressants in Chronic Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Descriptor Differential Scale Pain Intensity
研究概览
简要总结
The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient 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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic back pain (pain on a daily basis for six months or longer)
- •Age 18-65
- •No major medical illness
排除标准
- •medical contraindication to tricyclic antidepressants
- •recent alcohol or substance use disorder
- •bipolar disorder
研究组 & 干预措施
Arm 1
Desipramine, low, middle or high exposure
干预措施: Desipramine (Drug)
Arm 2
Fluoxetine, low, middle, or high exposure
干预措施: Fluoxetine (Drug)
Arm 3
Benztropine .125-.5mg daily
干预措施: Benztropine (Drug)
结局指标
主要结局
Descriptor Differential Scale Pain Intensity
时间窗: 12 weeks post baseline
次要结局
未报告次要终点