Sinusitis and Facial Pain Disorders Anti-Depression Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Sino-Nasal Outcome Test-20 (SNOT-20)
研究概览
简要总结
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.
详细描述
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 explaining this trial and that their patient may be taking an anti-depressant or a placebo.
During the trial, the dose of escitalopram will start at 10mg per day for seven days followed by 20mg per day for fourteen days, then will be maintained or titrated up based on our study's titration protocol.
At the conclusion of three months of active drug, the patient will be given the opportunity to continue the medication through their primary care provider. A two week supply of the active anti-depressant will be available to buffer this transition for patient's randomized to escitalopram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
escitalopram 10mg - 30mg daily
干预措施: escitalopram (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
Sino-Nasal Outcome Test-20 (SNOT-20)
时间窗: baseline, 1 month, 3 months
次要结局
未报告次要终点
研究者
Greg Davis
Assistant Professor
University of Washington
