Clinical trial NCT03655184: An Observation Study on Neuropsychology and Serum Melatonin Level in Patients With Medication Overuse Headache
Official title: An Observation Study on Neuropsychology and Serum Melatonin Level in Patients With Medication Overuse Headache
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medication Overuse Headache
Keywords: melatonin
medication Overuse Headache
migraine
Neuropsychology
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients and inpatients in the First Affiliated Hospital of Nanjing Medical University

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 .

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

Primary outcomes:
measure: Serum melatonin level
timeFrame: 30 minutes
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 15 minutes
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: 15 minutes
measure: Leeds Dependence Questionnaire (LDQ)
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Neurology, the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Qi Wan, professor
role: STUDY_DIRECTOR
References: