An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Montgomery-Äsberg Depression Scale (MADRS)
研究概览
简要总结
Background: Although major depression and chronic headache are strongly associated, there is insufficient evidence on the use of antidepressants for this specific comorbidity. This trial aimed to investigate the efficiency and tolerability of duloxetine for this indication.
Methods: Thirty outpatients of our clinic, with DSM-IV major depression and concurrent primary chronic headache (chronic migraine, chronic tension-type headache or both), 18-55 years, were recruited from April 2006 to March 2007, if they scored >21 on the Montgomery-Äsberg Depression Scale (MADRS) and had no other significant clinical condition. Subjects received duloxetine 60 mg/day for 8 weeks. MADRS scores and a visual analog pain scale (VAS) were the co-primary outcome measures. WHO quality of life scale (WHOQoL BREF) scores and headache days/week were secondary outcome measures.Conclusion: In this preliminary open trial, duloxetine 60 mg/day was effective, fast acting and well tolerated for the treatment of comorbid major depression and chronic headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depression (according to DSM-IV criteria)
- •MADRS scores superior to 21
- •Subjects meeting the International Headache Society criteria for chronic primary headache (IHSC-2 codes 1.5.1, 1.6.1, 2.3.1, 2.3.2 and 2.4.3) (ICHS, 2003)
排除标准
- •Over 50% reduction on MADRS scores during wash-out period
- •Illicit drug or alcohol dependence
- •History of multiple allergies or hypersensitivity to duloxetine
- •History of epilepsy or significant neurological disorder
- •Significant suicide risk
- •Pregnancy or lactation
- •Sexually active female subjects not using an efficient contraceptive method
- •Significant laboratory abnormalities at baseline
- •Significant clinical disease
- •Subjects meeting DSM-IV criteria for somatisation disorder. (300.81) or presenting with delusional pain symptoms.
结局指标
主要结局
Montgomery-Äsberg Depression Scale (MADRS)
时间窗: 8 weeks
Visual Analog Scale for pain (VAS)
时间窗: 8 weeks
次要结局
- WHO Quality of Life Scale (WHOQOL BREF)(8 weeks)