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NCT02813447 · ClinicalTrials.gov registry record · NA
Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)
A NA study, sponsored by Duke University.
- Terminated
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT02813447 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 13 participants.
The verdict
NCT02813447, a NA study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Sertraline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-08 |
| Est. Completion | 2019-02-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02813447
The ClinicalTrials.gov registry entry for NCT02813447 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02813447 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02813447 about?
NCT02813447 is a clinical study titled "Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)". 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) undergoin...
What is the current status of trial NCT02813447?
This trial is currently terminated. It is a NA study. The enrollment target is 13 participants. The study started on 2016-08. Estimated completion is 2019-02-20.
What interventions are being tested in trial NCT02813447?
The interventions under investigation include: Placebo (DRUG), Sertraline (DRUG).
Who is sponsoring clinical trial NCT02813447?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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