Mathews 2016.

Trial name or title	Safety of anti‐depressant for Chronic Obstructive Pulmonary Disease (SAD‐COPD)
Methods	A prospective, randomised, double‐blinded, placebo‐controlled study to assess the effect of a selective serotonin reuptake inhibitor on 6‐minute walk distance, dyspnoea scores, and quality of life in patients with COPD undergoing pulmonary rehabilitation
Participants	30 participants that carry an ICD‐9 code diagnosis of COPD and/or interstitial lung disease and CES‐D (Center for Epidemiologic Studies ‐ Depression) score of > 16 will be recruited from Duke Pulmonary Rehabilitation Center.
Interventions	Intervention: Participants randomised to the intervention arm will be given active study medication (sertraline). Participants will take a 25 mg tablet by mouth daily, starting at visit 1 along with participating in the intensive pulmonary rehabilitation programme. Participants will be assessed at 1‐week intervals for tolerability and side effects; and if tolerating study medication, the dose will be increased weekly by 25 mg over the course of the first 4 weeks with maximum effective dose of 100 mg daily by the end of week 4. Participants will continue this dose over the course of the remaining 8 weeks of the study, while participating in the pulmonary rehabilitation programme. Placebo comparator: Participants randomised to the placebo arm will have the same procedures as in the study active‐medication arm with the exception that they will be receiving matched placebo.
Outcomes	Primary outcomes: Change in 6‐minute walk distance, change in dyspnoea scores, change in quality of life Secondary outcomes: Change in perceived stress, change in anxiety, change in depression, tolerability of medication
Starting date	27 June 2016
Contact information	Contact: Anne M Mathews anne.mathews@dm.duke.edu; Heather Kuehn heather.kuehn@duke.edu
Notes	‐

COPD: chronic obstructive pulmonary disease
 ICD‐9: Ninth Revision of the International Classification of Diseases