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

NCT ID: NCT03655184

Last Updated: 2019-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-10

Study Completion Date

2019-06-30

Brief Summary

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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

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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 .

Conditions

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Medication Overuse Headache

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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MOH group

Patients with medication overuse headache

No interventions assigned to this group

Episodic migraine group

Patients with episodic migraine

No interventions assigned to this group

Healthy group

No headache or other special medical history

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qi Wan, professor

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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Department of Neurology, the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qi Wan, professor

Role: CONTACT

13770316989

Huimin Tao, master

Role: CONTACT

15720809858

Facility Contacts

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Qi Wan, professor

Role: primary

13770316989

Huinin Tao, master

Role: backup

15720809858

References

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Tao H, Wan Q, Sun M, Cai K, Song Y, He M, Shen J. Involvement of Plasma Melatonin in Medication-Overuse Headache: A Cross-Sectional Study. Clin Neuropharmacol. 2024 Jan-Feb 01;47(1):12-16. doi: 10.1097/WNF.0000000000000573. Epub 2023 Oct 19.

Reference Type DERIVED
PMID: 37852214 (View on PubMed)

Other Identifiers

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2018-SR-239

Identifier Type: -

Identifier Source: org_study_id

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