Medication Overuse HeadacheNCT03655184
An Observation Study on Neuropsychology and Serum Melatonin Level in Patients With Medication Overuse Headache
An observational study of Medication Overuse Headache, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Overuse Headache
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2017to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients and inpatients in the First Affiliated Hospital of Nanjing Medical University
Who may be able to join
- 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
Who cannot join
- Subjects combine with other pain syndromes and long-term oral analgesics are needed
- History of bleeding disorders
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Qi Wan, professor, 13770316989, qi_wan@126.com
Huinin Tao, master, 15720809858, taohuiminsky@163.com
About this study
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.
Read the 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 .
- Conditions
- Medication Overuse Headache
- Keywords
- melatonin, medication Overuse Headache, migraine, Neuropsychology
- Medical subject headings
- Headache Disorders, Secondary, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Serum melatonin level
Blood samples taken for melatonin were centrifuged, and the serum content was separated and collected for analysis at -70 °C.
Measured: 30 minutes
Secondary outcomes (3)
Hospital Anxiety and Depression Scale (HADS)
The subscore of HADS >7 is considered as possible anxiety or depression.
Measured: 15 minutes
Pittsburgh sleep quality index (PSQI)
An overall score over 5 indicates poor sleep.
Measured: 15 minutes
Leeds Dependence Questionnaire (LDQ)
The LDQ is a 10-item, self completion questionnaire designed to measure dependence upon a variety of substances.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start10 Sep 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication Overuse HeadacheStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qi Wan, professor, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655184
- Sponsor's protocol ID
- 2018-SR-239
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2018
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37852214
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observation Study on Neuropsychology and Serum Melatonin Level in Patients With Medication Overuse Headache
- ClinicalTrials.gov ID
- NCT03655184
- Acronym / sponsor ID
- 2018-SR-239
- Conditions
- Medication Overuse Headache
- Keywords
- melatonin, medication Overuse Headache, migraine, Neuropsychology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MOH group | – | –Patients with medication overuse headache |
| Episodic migraine group | – | –Patients with episodic migraine |
| Healthy group | – | –No headache or other special medical history |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients and inpatients in the First Affiliated Hospital of Nanjing Medical University
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects combine with other pain syndromes and long-term oral analgesics are needed
- History of bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 15 minutes
Pittsburgh sleep quality index (PSQI)
Time frame: 15 minutes
Leeds Dependence Questionnaire (LDQ)
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Derived from this study: PubMed 37852214Tao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Wan, professor study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Overuse Headache, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi Wan, professor (13770316989, qi_wan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum melatonin level (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03655184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.