Sinusitis and Facial Pain Disorders Anti-Depression Trial

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Forest Laboratories; National Institutes of Health (NIH)
• Treatments: Citalopram; Dexetimide

Criteria

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