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

Medication Overuse Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03655184
• Other study ID #: 2018-SR-239
• Status: Recruiting
• Start date: September 10, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2018
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Qi Wan, professor
• Phone: 13770316989
• Email: qi_wan[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache

Locations

Country	Name	City	State
China	Department of Neurology, the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

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