Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Anxiety, Lung Cancer, Chronic Obstructive Pulmonary Disease, Depression, Pulmonary |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 3/1/2019 |
| Start Date: | August 2016 |
| End Date: | December 2020 |
| Contact: | Anne M Mathews, MD |
| Email: | anne.mathews@dm.duke.edu |
| Phone: | 919-684-8111 |
Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease
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.
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.
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 consentâ€
- 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.
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