Clinical Trial: Sinusitis and Facial Pain Disorders Anti-Depression Trial
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Sinusitis and Facial Pain Disorders Anti-Depression Trial
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 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.
Detailed Summary:
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 examination, nasal endoscopy, and CT scan. Those patients who meet diagnostic criteria for CRS and for major depression will then be treated with three weeks of maximal medical therapy. Maximal medical therapy includes three weeks of a second-line antibiotic (such as Augmentin, azithromycin, or a fluoroquinolone), possible oral steroids based on the presence of inflammation or polyps in the sinuses, and nasal saline irrigations. They will then follow up with Dr. Davis in one month from their initial evaluation. Those who still do not have significantly improved symptoms (considered medical failures) will be approached and introduced to the study by Dr. Davis's medical assistant and then referred to the research assistant for further discussion and offered enrollment and consent if entry criteria are met. Note that if patients present for their initial consultation and have received maximal medical therapy from the referring clinician within the past two months, then they will be approached for possible entry into the study at that time.
Patients presenting with complaints of facial discomfort will also be included. These people often present with subjective sinusitis-like symptoms that are not objectively supported by CT scan or endoscopy. These patients are referred to the Neurology Clinic and will be asked to defer their appt. for the duration of the study.
Both patients and clinician will be blinded to the drug assignment. Subjects will be stratified according to facial pain or chronic sinusitis and then randomization will be done by restricted block randomization. A letter will be sent to each patient's primary care provider expla
Sponsor: University of Washington
Current Primary Outcome: Sino-Nasal Outcome Test-20 (SNOT-20) [ Time Frame: baseline, 1 month, 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome: Symptom Checklist-20 (SCL-20) [ Time Frame: Baseline, 1 month, 3 months ]
Information By: University of Washington
Dates:
Date Received: September 16, 2008
Date Started: January 2009
Date Completion:
Last Updated: December 16, 2013
Last Verified: December 2013
