A Quality of Life Study in Patients With Migraines

This study has been terminated.
(Study terminated due to expiration of IRB approval)
Sponsor:
Collaborators:
Rush University Medical Center
GlaxoSmithKline
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00298805
First received: March 1, 2006
Last updated: August 8, 2013
Last verified: August 2013
  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:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Dysphoric-like depressive characteristics in patient with epilepsy [ Time Frame: N/A (cross-sectional study) ] [ Designated as safety issue: No ]

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Locations
United States, New York
North Shore Long Island Jewish Health System
Great Neck, New York, United States, 11021
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Rush University Medical Center
GlaxoSmithKline
Investigators
Principal Investigator: Andres M Kanner, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
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
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Migraine
Headache
Depression
Quality of Life

Additional relevant MeSH terms:
Migraine Disorders
Depression
Depressive Disorder
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014