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

Nanjing Medical University

Status: Unknown

Conditions: Medication Overuse Headache

Study type: Observational

Funder types: Other

Identifiers

NCT03655184

2018-SR-239

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

MOH group

Description:

Patients with medication overuse headache

Episodic migraine group

Description:

Patients with episodic migraine

Healthy group

Description:

No headache or other special medical history