An Observation Study on Neuropsychology and Serum Melatonin Level in Patients With Medication Overuse Headache

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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 .

Official Title
-----------------
An Observation Study on Neuropsychology and Serum Melatonin Level in Patients With Medication Overuse Headache

Conditions
-----------------
Medication Overuse Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Subjects combine with other pain syndromes and long-term oral analgesics are needed History of bleeding disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MOH group<br>Patients with medication overuse headache | |
| Episodic migraine group<br>Patients with episodic migraine | |
| Healthy group<br>No headache or other special medical history | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum melatonin level | Blood samples taken for melatonin were centrifuged, and the serum content was separated and collected for analysis at -70 °C. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | The subscore of HADS >7 is considered as possible anxiety or depression. | 15 minutes | 
| Pittsburgh sleep quality index (PSQI) | An overall score over 5 indicates poor sleep. | 15 minutes | 
| Leeds Dependence Questionnaire (LDQ) | The LDQ is a 10-item, self completion questionnaire designed to measure dependence upon a variety of substances. | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melatonin, medication Overuse Headache, migraine, Neuropsychology