NCT00298805

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

3.4 years

First QC Date

March 1, 2006

Last Update Submit

August 8, 2013

Conditions

MigraineHeadacheDepression

Keywords

MigraineHeadacheDepressionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Dysphoric-like depressive characteristics in patient with epilepsy

    N/A (cross-sectional study)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Migraine patients will be recruited from the outpatient neurology clinics / offices.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore Long Island Jewish Health System

Great Neck, New York, 11021, United States

Location

MeSH Terms

Conditions

Migraine DisordersHeadacheDepression

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Andres M Kanner, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 3, 2006

Study Start

January 1, 2006

Primary Completion

June 1, 2009

Study Completion

April 1, 2013

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

US(1)