A Quality of Life Study in Patients With Migraines

Terminated

• Conditions: Migraine; Headache; Depression

• Registration Number: NCT00298805
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-01
• Study First Submitted QC: 2006-03-01
• Study First Posted: 2006-03-03
• Primary Completion: 2009-06
• Study Completion: 2013-04
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dysphoric-like depressive characteristics in patient with epilepsy	N/A (cross-sectional study)

Trial Locations

Locations (1)

North Shore Long Island Jewish Health System; 🇺🇸 Great Neck, New York, United States