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

June 24, 2019 updated by: The First Affiliated Hospital with Nanjing Medical University

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Department of Neurology, the First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients and inpatients in the First Affiliated Hospital of Nanjing Medical University

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MOH group
Patients with medication overuse headache
Episodic migraine group
Patients with episodic migraine
Healthy group
No headache or other special medical history

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum melatonin level
Time Frame: 30 minutes
Blood samples taken for melatonin were centrifuged, and the serum content was separated and collected for analysis at -70 °C.
30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Director: Qi Wan, professor, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2017

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-SR-239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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