MigraineNCT00298805
A Quality of Life Study in Patients With Migraines
An observational study of Migraine and Headache, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to compare depressive characteristics in migraine patients to those observed in patients with epilepsy in a previous study, and determine whether those symptoms are unique to patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Headache, Depression
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Migraine patients will be recruited from the outpatient neurology clinics / offices.
Who may be able to join
- Male or female 18 years of age or older
- Have the diagnosis of migraine
- Have had no change in migraine medication(s) 30 days prior to study
- Achieve a satisfactory score on the Wide Range Achievement Test 3 (WRAT3) test at the screening visit
- Capable of completing self-reporting questionnaires
- Willing and able to provide written informed consent and comply with the study protocol
Who cannot join
- Presence of a clinically significant comorbidity of an unstable or progressive nature
- Presence of major depression
- Participation in an investigational drug study within the past 30 days
- Inability to communicate well with site study personnel
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore Long Island Jewish Health System
Great Neck, New York, 11021
About this study
Official title: Dysphoric-like Disorder of Epilepsy, Is It Unique?
The purpose of this study is to compare depressive characteristics in migraine patients to those observed in patients with epilepsy in a previous study, and determine whether those symptoms are unique to patients with epilepsy.
Read the detailed description
A form of depression known as dysphoric-like disorder is common in people with epilepsy, which may significantly affect the quality of life in these people, as shown in a previous study. However, it is unclear if this depressive disorder is unique to patients with epilepsy. In order to assess whether these symptoms are unique and idiosyncratic to the epilepsy population, in this multi-center study, these dysphoric depressive features will be contrasted to those seen in patients with other neurologic or psychiatric conditions. Migraine is selected as one of the comparison disorders because it shares with epilepsy characteristics of being a recurrent episodic central nervous system disorder, and our site will only enroll patients with migraine headaches.
- Conditions
- Migraine, Headache, Depression
- Keywords
- Migraine, Headache, Depression, Quality of Life
- Medical subject headings
- Migraine Disorders, Headache, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphoric-like depressive characteristics in patient with epilepsy
Measured: N/A (cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionJun 2009
- Study completionApr 2013
Why it stopped: Study terminated due to expiration of IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Andres M Kanner, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298805
- Sponsor's protocol ID
- 05.02.073
- Status last verified
- Aug 2013
- First submitted
- 1 Mar 2006
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphoric-like Disorder of Epilepsy, Is It Unique?
- ClinicalTrials.gov ID
- NCT00298805
- Acronym / sponsor ID
- 05.02.073
- Conditions
- Migraine, Headache, Depression
- Keywords
- Migraine, Headache, Depression, Quality of Life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to expiration of IRB approval
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Rush University Medical Center, GlaxoSmithKline
- Study start
- Jan 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Mar 2006 (estimated)
- 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.
The purpose of this study is to compare depressive characteristics in migraine patients to those observed in patients with epilepsy in a previous study, and determine whether those symptoms are unique to patients with epilepsy.
Detailed description
A form of depression known as dysphoric-like disorder is common in people with epilepsy, which may significantly affect the quality of life in these people, as shown in a previous study. However, it is unclear if this depressive disorder is unique to patients with epilepsy. In order to assess whether these symptoms are unique and idiosyncratic to the epilepsy population, in this multi-center study, these dysphoric depressive features will be contrasted to those seen in patients with other neurologic or psychiatric conditions. Migraine is selected as one of the comparison disorders because it shares with epilepsy characteristics of being a recurrent episodic central nervous system disorder, and our site will only enroll patients with migraine headaches.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Migraine patients will be recruited from the outpatient neurology clinics / offices.
Key inclusion criteria (6 listed)
- Male or female 18 years of age or older
- Have the diagnosis of migraine
- Have had no change in migraine medication(s) 30 days prior to study
- Achieve a satisfactory score on the Wide Range Achievement Test 3 (WRAT3) test at the screening visit
- Capable of completing self-reporting questionnaires
Key exclusion criteria (4 listed)
- Presence of a clinically significant comorbidity of an unstable or progressive nature
- Presence of major depression
- Participation in an investigational drug study within the past 30 days
- Inability to communicate well with site study personnel
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
Dysphoric-like depressive characteristics in patient with epilepsy
Time frame: N/A (cross-sectional study)
Results and safety
The study was stopped early (reason given: Study terminated due to expiration of IRB approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
Andres M Kanner, MD principal investigator
Rush University Medical Center
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 Migraine and Headache, run by Northwell Health at 1 site in United States.
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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Aug 2013. 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 United States. 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?
The study was stopped early (reason given: Study terminated due to expiration of IRB approval). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphoric-like depressive characteristics in patient with epilepsy (time frame: N/A (cross-sectional study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2013.