Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00754793
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00754793
Study Brief:
Protocol Section:
NCT00754793