Sinusitis and Facial Pain Disorders Anti-Depression Trial

NCT00754793 | Terminated Phase 4 Results

• 3 other identifiers: 33501-B1KL2RR025015-01 (NIH)1KL2RR025015-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Sinusitis; Facial Pain Disorder; Depression

Outcome Measures

Primary Outcomes (1)

• Sino-Nasal Outcome Test-20 (SNOT-20)

  baseline, 1 month, 3 months

Study Arms (2)

1

ACTIVE COMPARATOR

escitalopram 10mg - 30mg daily

Drug: escitalopram

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

escitalopram DRUG

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

Also known as: Lexapro (escitalopram)

1

placebo DRUG

inactive comparator; titrated as per protocol over 12 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meet diagnostic criteria for chronic sinusitis
• meet diagnostic criteria for facial pain disorder
• meet criteria for major depressive disorder on the PHQ-9
• years of age or older
• established primary care provider
• able to read and speak English

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator
• Forest Laboratories: collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Greg E. Davis, MD MPH
• Organization: University of Washington

gedavis@uw.edu

206-543-5230

Study Officials

• Greg E Davis, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: January 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2012
• Last Updated: January 17, 2014
• Results First Posted: August 3, 2012

Record last verified: 2013-12

Locations

US (1)