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A Quality of Life Study in Patients With Migraines
This study has been terminated.
(Study terminated due to expiration of IRB approval)
Sponsor:
Northwell Health
Collaborators:
Rush University Medical Center
GlaxoSmithKline
Information provided by (Responsible Party):
Northwell Health
ClinicalTrials.gov Identifier:
NCT00298805
First received: March 1, 2006
Last updated: August 8, 2013
Last verified: August 2013
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Purpose
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.
| Condition |
|---|
| Migraine Headache Depression |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Dysphoric-like Disorder of Epilepsy, Is It Unique? |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by Northwell Health:
Primary Outcome Measures:
- Dysphoric-like depressive characteristics in patient with epilepsy [ Time Frame: N/A (cross-sectional study) ]
| Enrollment: | 52 |
| Study Start Date: | January 2006 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Migraine patients will be recruited from the outpatient neurology clinics / offices.
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298805
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298805
Locations
| United States, New York | |
| North Shore Long Island Jewish Health System | |
| Great Neck, New York, United States, 11021 | |
Sponsors and Collaborators
Northwell Health
Rush University Medical Center
GlaxoSmithKline
Investigators
| Principal Investigator: | Andres M Kanner, MD | Rush University Medical Center |
More Information
| Responsible Party: | Northwell Health |
| ClinicalTrials.gov Identifier: | NCT00298805 History of Changes |
| Other Study ID Numbers: |
05.02.073 |
| Study First Received: | March 1, 2006 |
| Last Updated: | August 8, 2013 |
Keywords provided by Northwell Health:
|
Migraine Headache Depression Quality of Life |
Additional relevant MeSH terms:
|
Depression Migraine Disorders Headache Behavioral Symptoms Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on July 18, 2017