Observational Study Evaluating the Efficacy and Tolerability of Agomelatine in the Treatment of Depressed Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- change, from baseline to endpoint, in the Beck's depression inventory score
研究概览
简要总结
Depression and unrefreshed sleep are frequent in patients with fibromyalgia. Agomelatine is a new antidepressant with sleep-promoting properties. The objective of this study include the assessment of agomelatine therapy in patients with depression and fibromyalgia both on the severity of depressive symptomatology and sleep quality.
详细描述
One of the most frequent comorbidities of fibromyalgia is major depression. Agomelatine is a new antidepressant whose mechanims of action include both agonism at melatonin receptores and 5-HT2C blocking properties which, in addition to antidepressant efficacy, has shown sleep-improving properties. As unrefreshed sleep is a common symptom in fibromyalgia we hypothetized that agomelatine treatment of patients with concomitant depression and fibromyalgia could improve both depressive symtomatology and sleep quality. Thus, the objectives of the present study are the following:
- to assess the effectiveness and tolerability of agomelatine on the severity of depressive symptomatology in patients with fibromyalgia and concomitatnt depresssion
- to evaluate the effect of agomelatine treatment on sleep quality in these patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •diagnosed of fibromyalgia according to the American College of Rheumatology criteria
- •diagnosed of major depression according to the DSM-IV criteria with a BDI-II score equal or higher tahn 20
排除标准
- •other psychiastric concomitant illness
- •pregnancy or lactation
- •patients previously treated with agomelatine with little or no effect
研究组 & 干预措施
agomelatine
patients diagnosed of fibromyalgia and concomitant major depression receiving agomelatine for this later disease
干预措施: agomelatine (Drug)
结局指标
主要结局
change, from baseline to endpoint, in the Beck's depression inventory score
时间窗: 12 weeks
次要结局
- change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory(12 weeks)
研究者
Elena Pita Calandre
Professor
Universidad de Granada