COPDSAD-COPDNCT02813447
Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)
A study testing Sertraline in people with COPD and Anxiety, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Anxiety, Depression
- What is being tested?
- Sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 20 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Pulmonary Rehabilitation
Durham, North Carolina, 27705
About this study
Official title: 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.
Read more
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.
- Conditions
- COPD, Anxiety, Depression, Stress, Interstitial Lung Disease
- Being tested
- Sertraline, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Depression, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehab + Study Drug | Active comparator | 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. Receives: Drug: Sertraline |
| Pulmonary Rehab + Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6MW Distance
Patients will undergo 6-minute walk at visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Measured: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Change in Dyspnea Scores, as Measured by UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB)
To monitor changes in dyspnea scores, patients will complete the UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB). Participants will complete this at all visits (1-6). The UCSD is a 24-item questionnaire that asks participants to rate themselves from 0 ("Not at all") to 5 ("Maximally or unable to do because of breathlessness"). Scores range from 0-120, with higher scores indicating greater dyspnea.
Measured: visit 1(baseline), visit 4 (week 4), visit 6 (week 12)
Secondary outcomes (4)
Change in Quality of Life, as Measured by Ferrans & Powers Quality of Life Index - Pulmonary Version (QOL)
To monitor changes in quality of life, patients will complete the Ferrans \& Powers Quality of Life Index - Pulmonary version (QOL). Scores range from 0 to 30, with higher scores indicating a higher quality of life.
Measured: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Change in Perceived Stress, as Measured by General Health Questionnaire-12 (GHQ-12)
To monitor changes in perceived stress, patients will complete the General Health Questionnaire-12 (GHQ-12). Scores range from 0 to 36, with higher scores indicating greater distress.
Measured: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Change in Anxiety, as Measured by Hamilton Anxiety and Depression Scale (HADS)
Scores on the HADS range from 0-21, with higher scores indicating more severe of symptoms.
Measured: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Change in Anxiety, as Measured by the Anxiety Inventory for Respiratory Disease (AIR) Questionnaire
Scores on the Anxiety Inventory for Respiratory Disease (AIR) range from 0-30, with higher scores indicating more symptoms.
Measured: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Why it stopped: COVID-19 hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Mathews, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813447
- Sponsor's protocol ID
- Pro00071349
- Acronym
- SAD-COPD
- Status last verified
- Sep 2021
- First submitted
- 13 Jun 2016
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02813447
- Acronym / sponsor ID
- SAD-COPD / Pro00071349
- Conditions
- COPD, Anxiety, Depression, Stress, Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 hold
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Posted 1 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehab + Study Drug | Active comparator | Drug: SertralineSubjects 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. |
| Pulmonary Rehab + Placebo | Placebo comparator | Drug: PlaceboSubjects 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sertraline | Drug | Pulmonary Rehab + Study Drug |
| Placebo | Drug | Pulmonary Rehab + Placebo |
Primary outcome
Change in 6MW Distance
Time frame: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Patients will undergo 6-minute walk at visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Change in Dyspnea Scores, as Measured by UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB)
Time frame: visit 1(baseline), visit 4 (week 4), visit 6 (week 12)
To monitor changes in dyspnea scores, patients will complete the UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB). Participants will complete this at all visits (1-6). The UCSD is a 24-item questionnaire that asks participants to rate themselves from 0 ("Not at all") to 5 ("Maximally or unable to do because of breathlessness"). Scores range from 0-120, with higher scores indicating greater dyspnea.
4 secondary outcomes
Change in Quality of Life, as Measured by Ferrans & Powers Quality of Life Index - Pulmonary Version (QOL)
Time frame: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Change in Perceived Stress, as Measured by General Health Questionnaire-12 (GHQ-12)
Time frame: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Change in Anxiety, as Measured by Hamilton Anxiety and Depression Scale (HADS)
Time frame: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Change in Anxiety, as Measured by the Anxiety Inventory for Respiratory Disease (AIR) Questionnaire
Time frame: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Mathews, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertraline in people with COPD and Anxiety, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6MW Distance (time frame: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.