Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)

Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02813447

Acronym

SAD-COPD

Enrollment

Registered

2016-06-27

Start date

2016-08-31

Completion date

2019-02-20

Last updated

2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, COPD, Depression, Interstitial Lung Disease, Stress

Brief 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

DRUGSertraline

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in 6MW Distance	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)	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.

Secondary

Measure	Time frame	Description
Change in Quality of Life, as Measured by Ferrans & Powers Quality of Life Index - Pulmonary Version (QOL)	visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).	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.
Change in Perceived Stress, as Measured by General Health Questionnaire-12 (GHQ-12)	visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 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.
Change in Anxiety, as Measured by Hamilton Anxiety and Depression Scale (HADS)	visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).	Scores on the HADS range from 0-21, with higher scores indicating more severe of symptoms.
Change in Anxiety, as Measured by the Anxiety Inventory for Respiratory Disease (AIR) Questionnaire	visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).	Scores on the Anxiety Inventory for Respiratory Disease (AIR) range from 0-30, with higher scores indicating more symptoms.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	6
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	7
Total	13

Baseline characteristics

Characteristic	Pulmonary Rehab + Study Drug	Pulmonary Rehab + Placebo	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	5 Participants	6 Participants	11 Participants
Age, Categorical Between 18 and 65 years	1 Participants	1 Participants	2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants	7 Participants	13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	2 Participants	3 Participants	5 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	4 Participants	4 Participants	8 Participants
Region of Enrollment United States	6 participants	7 participants	13 participants
Sex: Female, Male Female	3 Participants	2 Participants	5 Participants
Sex: Female, Male Male	3 Participants	5 Participants	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 6	0 / 7
other Total, other adverse events	2 / 6	0 / 7
serious Total, serious adverse events	1 / 6	0 / 7

Outcome results

Primary

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).

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Pulmonary Rehab + Study Drug	Change in 6MW Distance	change from baseline to Visit 4	-264.00 feet	Standard Deviation 0
Pulmonary Rehab + Study Drug	Change in 6MW Distance	change from baseline to Visit 6	-94.00 feet	Standard Deviation 0
Pulmonary Rehab + Placebo	Change in 6MW Distance	change from baseline to Visit 6	163.60 feet	Standard Deviation 312.5
Pulmonary Rehab + Placebo	Change in 6MW Distance	change from baseline to Visit 4	273.20 feet	Standard Deviation 103.89

Primary

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.

Time frame: visit 1(baseline), visit 4 (week 4), visit 6 (week 12)