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

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ClinicalTrials.gov Identifier: NCT03655184
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Medication Overuse Headache

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
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: An Observation Study on Neuropsychology and Serum Melatonin Level in Patinets With Medication Overuse Headache
Actual Study Start Date : September 10, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 15 minutes ]
    The subscore of HADS >7 is considered as possible anxiety or depression.

  2. Pittsburgh sleep quality index (PSQI) [ Time Frame: 15 minutes ]
    An overall score over 5 indicates poor sleep.

  3. 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.


Biospecimen Retention:   Samples Without DNA
Serum samples were stored at -70 ℃


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatients and inpatients in the First Affiliated Hospital of Nanjing Medical University
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655184


Contacts
Contact: Qi Wan, professor 13770316989 qi_wan@126.com
Contact: Huimin Tao, master 15720809858 taohuiminsky@163.com

Locations
China, Jiangsu
Department of Neurology, the First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Qi Wan, professor    13770316989    qi_wan@126.com   
Contact: Huinin Tao, master    15720809858    taohuiminsky@163.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
Study Director: Qi Wan, professor The First Affiliated Hospital with Nanjing Medical University

Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03655184     History of Changes
Other Study ID Numbers: 2018-SR-239
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
melatonin
medication Overuse Headache
migraine
Neuropsychology

Additional relevant MeSH terms:
Headache
Headache Disorders, Secondary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants