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Sinusitis and Facial Pain Disorders Anti-Depression Trial

NCT00754793 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2014-01-17

Study results available
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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.

Conditions

  • Chronic Sinusitis
  • Facial Pain Disorder
  • Depression

Interventions

DRUG

escitalopram

10mg - 30mg daily titrated as tolerated over 12 weeks

DRUG

placebo

inactive comparator; titrated as per protocol over 12 weeks

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Forest Laboratories

    collaborator INDUSTRY

  • University of Washington

    lead OTHER

Principal Investigators

  • Greg E Davis, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-08-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00754793 on ClinicalTrials.gov