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A Quality of Life Study in Patients With Migraines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298805
Recruitment Status : Terminated (Study terminated due to expiration of IRB approval)
First Posted : March 3, 2006
Last Update Posted : August 12, 2013
Rush University Medical Center
Information provided by (Responsible Party):
Northwell Health

Brief 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.

Condition or disease
Migraine Headache Depression

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.

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dysphoric-like Disorder of Epilepsy, Is It Unique?
Study Start Date : January 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Migraine

Primary Outcome Measures :
  1. Dysphoric-like depressive characteristics in patient with epilepsy [ Time Frame: N/A (cross-sectional study) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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 identifier (NCT number): NCT00298805

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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
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Principal Investigator: Andres M Kanner, MD Rush University Medical Center
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Responsible Party: Northwell Health Identifier: NCT00298805    
Other Study ID Numbers: 05.02.073
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013
Keywords provided by Northwell Health:
Quality of Life
Additional relevant MeSH terms:
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Migraine Disorders
Behavioral Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations