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

• Conditions: Medication Overuse Headache

• Registration Number: NCT03655184
• Lead Sponsor: The First Affiliated Hospital with 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 .

Study Timeline

• Study Start: 2017-09-10
• Status Verified: 2018-08
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-26
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum melatonin level	30 minutes	Blood samples taken for melatonin were centrifuged, and the serum content was separated and collected for analysis at -70 °C.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Neurology, the First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China