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
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|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|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|
Patients with medication overuse headache
Episodic migraine group
Patients with episodic migraine
No headache or other special medical history
- 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.
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 15 minutes ]The subscore of HADS >7 is considered as possible anxiety or depression.
- Pittsburgh sleep quality index (PSQI) [ Time Frame: 15 minutes ]An overall score over 5 indicates poor sleep.
- 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
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
|Contact: Qi Wan, firstname.lastname@example.org|
|Contact: Huimin Tao, email@example.com|
|Department of Neurology, the First Affiliated Hospital of Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210029|
|Contact: Qi Wan, professor 13770316989 firstname.lastname@example.org|
|Contact: Huinin Tao, master 15720809858 email@example.com|
|Study Director:||Qi Wan, professor||The First Affiliated Hospital with Nanjing Medical University|