Trial Outcomes & Findings for Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD) (NCT NCT02813447)
NCT ID: NCT02813447
Last Updated: 2025-07-01
Results Overview
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).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
Results posted on
2025-07-01
Participant Flow
Participant milestones
| Measure |
Pulmonary Rehab + Study Drug
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.
Sertraline
|
Pulmonary Rehab + Placebo
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.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
1
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)
Baseline characteristics by cohort
| Measure |
Pulmonary Rehab + Study Drug
n=6 Participants
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.
Sertraline
|
Pulmonary Rehab + Placebo
n=7 Participants
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.
Placebo
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).Population: only participants who completed all 3 visits (visits 1, 4, and 6) were included in the analysis.
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).
Outcome measures
| Measure |
Pulmonary Rehab + Study Drug
n=1 Participants
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.
Sertraline
|
Pulmonary Rehab + Placebo
n=5 Participants
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.
Placebo
|
|---|---|---|
|
Change in 6MW Distance
change from baseline to Visit 4
|
-264.00 feet
Standard Deviation 0
|
273.20 feet
Standard Deviation 103.89
|
|
Change in 6MW Distance
change from baseline to Visit 6
|
-94.00 feet
Standard Deviation 0
|
163.60 feet
Standard Deviation 312.50
|
PRIMARY outcome
Timeframe: visit 1(baseline), visit 4 (week 4), visit 6 (week 12)Population: Participants with data at the indicated time points are included in the analysis. All collected data are reported.
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.
Outcome measures
| Measure |
Pulmonary Rehab + Study Drug
n=3 Participants
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.
Sertraline
|
Pulmonary Rehab + Placebo
n=4 Participants
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.
Placebo
|
|---|---|---|
|
Change in Dyspnea Scores, as Measured by UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB)
Baseline
|
62.67 score on a scale
Standard Deviation 8.08
|
36.00 score on a scale
Standard Deviation 14.33
|
|
Change in Dyspnea Scores, as Measured by UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB)
Change from Baseline to Visit 4
|
-0.50 score on a scale
Standard Deviation 6.36
|
7.50 score on a scale
Standard Deviation 26.16
|
|
Change in Dyspnea Scores, as Measured by UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB)
Change from Baseline to Visit 6
|
0.00 score on a scale
Standard Deviation 0.00
|
-14.00 score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).Population: Participants with data at the indicated time points are included in the analysis. All collected data are reported.
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.
Outcome measures
| Measure |
Pulmonary Rehab + Study Drug
n=6 Participants
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.
Sertraline
|
Pulmonary Rehab + Placebo
n=7 Participants
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.
Placebo
|
|---|---|---|
|
Change in Quality of Life, as Measured by Ferrans & Powers Quality of Life Index - Pulmonary Version (QOL)
Baseline
|
19.23 score on a scale
Standard Deviation 5.26
|
20.12 score on a scale
Standard Deviation 2.77
|
|
Change in Quality of Life, as Measured by Ferrans & Powers Quality of Life Index - Pulmonary Version (QOL)
Change from Baseline to Visit 4
|
4.53 score on a scale
Standard Deviation 0.00
|
-0.40 score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).Population: Participants with data at the indicated time points are included in the analysis. All collected data are reported.
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.
Outcome measures
| Measure |
Pulmonary Rehab + Study Drug
n=3 Participants
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.
Sertraline
|
Pulmonary Rehab + Placebo
n=4 Participants
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.
Placebo
|
|---|---|---|
|
Change in Perceived Stress, as Measured by General Health Questionnaire-12 (GHQ-12)
Baseline
|
16.33 score on a scale
Standard Deviation 6.51
|
11.50 score on a scale
Standard Deviation 5.07
|
|
Change in Perceived Stress, as Measured by General Health Questionnaire-12 (GHQ-12)
GHQ Change from Baseline to Visit 4
|
-2.50 score on a scale
Standard Deviation 2.12
|
-3.67 score on a scale
Standard Deviation 3.79
|
|
Change in Perceived Stress, as Measured by General Health Questionnaire-12 (GHQ-12)
GHQ Change from Baseline to Visit 6
|
—
|
-7.00 score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).Population: Participants with data at the indicated time points are included in the analysis. All collected data are reported.
Scores on the HADS range from 0-21, with higher scores indicating more severe of symptoms.
Outcome measures
| Measure |
Pulmonary Rehab + Study Drug
n=3 Participants
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.
Sertraline
|
Pulmonary Rehab + Placebo
n=4 Participants
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.
Placebo
|
|---|---|---|
|
Change in Anxiety, as Measured by Hamilton Anxiety and Depression Scale (HADS)
Baseline
|
16.67 score on a scale
Standard Deviation 6.11
|
11.00 score on a scale
Standard Deviation 6.98
|
|
Change in Anxiety, as Measured by Hamilton Anxiety and Depression Scale (HADS)
Change from Baseline to Visit 4
|
-6.50 score on a scale
Standard Deviation 3.54
|
-0.67 score on a scale
Standard Deviation 2.08
|
|
Change in Anxiety, as Measured by Hamilton Anxiety and Depression Scale (HADS)
Change from Baseline to Visit 6
|
-3.00 score on a scale
Standard Deviation 0.00
|
-7.00 score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).Population: Participants with data at the indicated time points are included in the analysis. All collected data are reported.
Scores on the Anxiety Inventory for Respiratory Disease (AIR) range from 0-30, with higher scores indicating more symptoms.
Outcome measures
| Measure |
Pulmonary Rehab + Study Drug
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.
Sertraline
|
Pulmonary Rehab + Placebo
n=1 Participants
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.
Placebo
|
|---|---|---|
|
Change in Anxiety, as Measured by the Anxiety Inventory for Respiratory Disease (AIR) Questionnaire
Baseline
|
—
|
15.00 score on a scale
Standard Deviation 0.00
|
Adverse Events
Pulmonary Rehab + Study Drug
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Pulmonary Rehab + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pulmonary Rehab + Study Drug
n=6 participants at risk
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.
Sertraline
|
Pulmonary Rehab + Placebo
n=7 participants at risk
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.
Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
16.7%
1/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
Other adverse events
| Measure |
Pulmonary Rehab + Study Drug
n=6 participants at risk
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.
Sertraline
|
Pulmonary Rehab + Placebo
n=7 participants at risk
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.
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
nausea, vomiting and jitteriness
|
16.7%
1/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
General disorders
drowsiness, lethargy and jitteriness
|
16.7%
1/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place