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

Primary Purpose

COPD, Anxiety, Depression

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sertraline
Placebo
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Duke Pulmonary Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pulmonary Rehab + Study Drug

Pulmonary Rehab + Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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). Patients will complete this at all visits (1-6).
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). Patients will complete this at all visits (1-6).

Secondary Outcome Measures

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).
Change in anxiety, as measured by Hamilton Anxiety and Depression Scale (HADS)
Change in anxiety, as measured by Anxiety Inventory for Respiratory Disease (AIR)
Change in depression, as measured by Hamilton Anxiety and Depression Scale (HADS)
Tolerability as measured by evidence of serotonin syndrome, significant agitation or tremor, worsening in anxiety or depression such that the subject is having suicidal ideation or intent
Intolerability will be defined as evidence of serotonin syndrome, significant agitation or tremor, worsening in anxiety or depression such that the subject is having suicidal ideation or intent.

Full Information

First Posted
June 13, 2016
Last Updated
September 1, 2021
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02813447
Brief Title
Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)
Acronym
SAD-COPD
Official Title
Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 hold
Study Start Date
August 2016 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
February 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Anxiety, Depression, Stress, Interstitial Lung Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary Rehab + Study Drug
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pulmonary Rehab + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in 6MW distance
Description
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).
Title
Change in dyspnea scores, as measured by UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB)
Description
To monitor changes in dyspnea scores, patients will complete the UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB). Patients will complete this at all visits (1-6).
Time Frame
visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Title
Change in quality of life, as measured by Ferrans & Powers Quality of Life Index - Pulmonary version (QOL)
Description
To monitor changes in quality of life, patients will complete the Ferrans & Powers Quality of Life Index - Pulmonary version (QOL). Patients will complete this at all visits (1-6).
Time Frame
visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Secondary Outcome Measure Information:
Title
Change in perceived stress, as measured by General Health Questionnaire-12 (GHQ-12)
Description
To monitor changes in perceived stress, patients will complete the General Health Questionnaire-12 (GHQ-12).
Time Frame
visit 1 (baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Title
Change in anxiety, as measured by Hamilton Anxiety and Depression Scale (HADS)
Time Frame
visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Title
Change in anxiety, as measured by Anxiety Inventory for Respiratory Disease (AIR)
Time Frame
visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Title
Change in depression, as measured by Hamilton Anxiety and Depression Scale (HADS)
Time Frame
visit 1 (baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Title
Tolerability as measured by evidence of serotonin syndrome, significant agitation or tremor, worsening in anxiety or depression such that the subject is having suicidal ideation or intent
Description
Intolerability will be defined as evidence of serotonin syndrome, significant agitation or tremor, worsening in anxiety or depression such that the subject is having suicidal ideation or intent.
Time Frame
visit 2 (week 2), visit 3 (week 3), visit 4 (week 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Mathews, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Pulmonary Rehabilitation
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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

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