Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)
Status:
Terminated
Trial end date:
2019-02-20
Target enrollment:
Participant gender:
Summary
Objective: Determine whether treatment of perceived stress, anxiety, and depression with
anti-depressant therapy improves dyspnea scores, 6-minute walk (6MW) distance and quality of
life (QoL) in patients with Chronic Obstructive Pulmonary Disease (COPD) and ILD
(Interstitial Lung Disease) undergoing pulmonary rehab.
The study is a prospective, randomized, double-blinded, placebo-controlled study to assess
the effect of an SSRI on 6MW, dyspnea scores, and QoL in COPD and ILD patients undergoing
pulmonary rehab. Thirty subjects that carry an ICD-9 code diagnosis of COPD and/or ILD and
CES-D (Center for Epidemiologic Studies Depression) score of > 16 will be recruited from Duke
Pulmonary Rehab.
Multivariable regression models will be constructed to evaluate the relationship between
perceived stress, anxiety, and depression with adjustments by race, gender, age, BMI and GOLD
score. A multivariable regression model will be constructed to assess whether treatment of
perceived stress, depression, and anxiety with antidepressant therapy (sertraline) is an
effect modifier on 6MW distance and dyspnea scores in patients with COPD or ILD who are
enrolled in pulmonary rehab.
Descriptive statistics will be used to examine the socio-demographic characteristic data.
Student t-tests will be performed to assess group differences in continuous data. Categorical
variables will be examined using the Pearson's Chi-Squared test.