An Observation Study on Neuropsychology and Serum Melatonin Level in Patients With Medication Overuse Headache
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Serum melatonin level
研究概览
简要总结
Medication overuse headache (MOH) is a disabling and costly disorder which is characterized by chronic headache and overuse of different headache medications. Patients with MOH are more likely to coexist with affective disorders such as anxiety and depression, and are more likely to suffer from sleep disturbances than those with episodic headache.
Melatonin is a hormone secreted from the pineal gland. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic.
This observational study aims to investigate clinical characteristics of patients with MOH and to explore the relationship between the serum melatonin level and medication overuse headache. Researchers hope to provide a new idea for the clinical treatment of MOH: melatonin can be used as an adjuvant therapy for MOH in the future.
详细描述
30 patients with MOH，30 patients with episodic migraine and 30 age-matched healthy volunteers were recruited in the study. A series of neuropsychological test scale including Hospital Anxiety and Depression Scale (HADS), Pittsburgh sleep quality index (PSQI) and Leeds Dependence Questionnaire (LDQ) were evaluated among all the recruited. Blood samples were taken at 10 a.m. and centrifuged. The serum was separated and collected at -70 °C for the measurement of melatonin .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has medication overuse headache. Headache occurring on 15 or more days per month for more than 3 months. The number of medication days ≥10 days/month for triptans, ergotamine, opioids, combination analgesics, or multiple drug classes not individually overused; ≥15 days/ month for simple analgesic
- •Subject has had 1-8 migraines per month over the previous 3 months
- •Sign the informed consent
排除标准
- •Subjects combine with other pain syndromes and long-term oral analgesics are needed
- •History of bleeding disorders
结局指标
主要结局
Serum melatonin level
时间窗: 30 minutes
Blood samples taken for melatonin were centrifuged, and the serum content was separated and collected for analysis at -70 °C.
次要结局
- Leeds Dependence Questionnaire (LDQ)(15 minutes)
- Hospital Anxiety and Depression Scale (HADS)(15 minutes)
- Pittsburgh sleep quality index (PSQI)(15 minutes)