Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline
研究概览
简要总结
Duloxetine is FDA approved as pharmacological treatment for Fibromyalgia. The use of SSRIs has been endorsed by the 2013 Canadian guidelines. The data available for Escitalopram as a treatment modality for Fibromyalgia is limited, however small trials have demonstrated its efficacy. No head to head comparisons between escitalopram and duloxetine have been undertaken. We aim to conduct a single blind, randomized control trial to assess the comparative efficacy of duloxetine vs escitalopram in drug naive patients with newly diagnosed Fibromyalgia.
详细描述
180 drug naive patients with newly diagnosed fibromyalga according to the modified ACR 2016 criteria shall be enrolled by consecutive sampling after taking written informed consent. Baseline severity of fibromyalgia shall be assessed via the Revised Fibromyalgia Impact Questionnaire (FIQ-R). They shall be randomized via cluster randomization into two groups. The first group shall receive Duloxetine 30mg, will be increased to 60mg after one week. The second group shall receive Escitalopram 10mg to be increased to 20mg after one week. Patients shall be followed at 0,2,4,8 and 12 weeks. At each visit, any subjective change in symptoms shall be noted and the FIQ-R shall be re administered. At the end of the trial, the overall change in the FIQ-R from baseline shall be assessed and the difference between both groups will be analyzed.
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
- Single (Participant)
盲法说明
Patients shall be provided medication with numeric labels
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug Naive patients
- •Newly diagnosed with FIbromyalgia according to Modified ACR 2016 criteria
排除标准
- •Concomitant depression/bipolar disorder or any other documented psychiatric illness
- •Autoimmune disorders (SLE, RA)
- •Peripheral Neuropathic pain due to any cause
- •Uncontrolled hypertension
- •Impaired renal or hepatic functions (on Lab assay)
- •Chronic infections (e.g.Tuberculosis)
研究组 & 干预措施
Duloxetine Group
Duloxetine 30mg once daily to be started for 1 week. Dose will then be titrated to 60mg once daily and the patients followed for a total of 12 weeks.
干预措施: Duloxetine (Drug)
Escitalopram Group
Escitalopram 10mg once daily to be started for 1 week. Dose will then be titrated to 20mg once daily and the patients followed for a total of 12 weeks.
干预措施: Escitalopram (Drug)
结局指标
主要结局
Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline
时间窗: 4,8 and 12 weeks
Percentage decrease in FIQ-R from baseline
次要结局
未报告次要终点
研究者
DR. MOHAMMAD ALI ARIF
Assistant Professor of Medicine
Shaheed Zulfiqar Ali Bhutto Medical University