Sinusitis and Facial Pain Disorders Anti-Depression Trial
TerminatedPhase 4NCT00754793
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 decrease the report of chronic sinusitis or facial pain symptom severity. This is a stratified, randomized, double-blind, placebo-controlled study using the drug escitalopram for the treatment of depression in patients experiencing depression and chronic sinusitis or depression and facial pain disorders. It is a 12-week study. Subjects will have a screening visit and then be followed up by phone weekly for four weeks and bi-weekly for 8 weeks.
Study details
- Official title
- Sinusitis and Facial Pain Disorders Anti-Depression Trial
- Conditions
- Chronic Sinusitis
- Facial Pain Disorder
- Depression
- Interventions
- Drug: escitalopram
- Drug: placebo
- Sponsor
- University of Washington
- Collaborators
- National Institutes of Health (NIH); Forest Laboratories
- Start date
- 2009-01
- Primary completion
- 2010-08
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00754793