Status:
TERMINATED
Sinusitis and Facial Pain Disorders Anti-Depression Trial
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institutes of Health (NIH)
Forest Laboratories
Conditions:
Chronic Sinusitis
Facial Pain Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study hypothesis is that the addition of an antidepressant to the standard treatment regimen in patients with both chronic sinusitis and depression or facial pain disorders and depression will dec...
Detailed Description
All patients presenting to the University of Washington Medical Center Sinus Clinic are screened for depression with the PHQ-9 as a standard of care in their evaluation, as well as a physical examinat...
Eligibility Criteria
Inclusion
- meet diagnostic criteria for chronic sinusitis
- meet diagnostic criteria for facial pain disorder
- meet criteria for major depressive disorder on the PHQ-9
- 18 years of age or older
- established primary care provider
- able to read and speak English
Exclusion
- unable to give informed consent of unable to complete self-administered questionnaires due to cognitive impairment, language barriers or severe medical condition
- terminal illness or significantly immunocompromized
- complications from chronic rhinosinusitis
- presence of sinus tumor
- isolated sphenoid disease
- immotile cilia syndrome
- currently on anti-depressant or mood stabilizer med.
- diagnosis of bipolar disorder, schizophrenic disorders, paranoid disorders, or psychotic disorders NOS
- significant suicide risk
- history of hospitalization for mental disorders including psychosis or depression
- history of drug abuse within prev. 6 months or dependency on any drug, including alcohol
- pregnant or breast feeding
- women of child-bearing potential not currently using an approved method of birth control
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00754793
Start Date
January 1 2009
End Date
December 1 2012
Last Update
January 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Washington Medical Center
Seattle, Washington, United States, 98195