A Quality of Life Study in Patients With Migraines

NCT ID: NCT00298805

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Headache Depression

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Migraine Headache Depression Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rush University Medical Center

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andres M Kanner, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

North Shore Long Island Jewish Health System

Great Neck, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

05.02.073

Identifier Type: -

Identifier Source: org_study_id