Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD) (SAD-COPD)
COPD, Anxiety, Depression
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
- Male or female with an ICD-9 code diagnosis of COPD and/or ILD
- Mild, moderate, or severe major depression symptoms based on Center of Epidemiologic Studies Depression (CES-D) score > 16.
- Able to complete informed consent†
- Read and write in English
Exclusion Criteria:
- Current treatment with antidepressants
- Current treatment with anti-psychotics
- Severe physical disability that would interfere with lung assessment
- History of major psychiatric illness, including bipolar disorder, psychoses, and/or severe personality disorder.
- Active suicidal ideations
- Serious cognitive problems (dementia syndrome) or cognitive impairment defined as MMSE < 22
- Recent loss of spouse within 6 weeks of study enrollment.
- History of alcohol or drug dependence in the last 6 months.
- Pregnant women or nursing mothers
- Poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator.
Sites / Locations
- Duke Pulmonary Rehabilitation
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Pulmonary Rehab + Study Drug
Pulmonary Rehab + Placebo
Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.
Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.