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

NCT02813447 | Terminated Results

• 1 other identifier: Pro00071349
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Anxiety; Depression; Stress; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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)

  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)

  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)

  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

  visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Sertraline DRUG

Pulmonary Rehab + Study Drug

Placebo DRUG

Pulmonary Rehab + Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Pulmonary Rehabilitation

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Anxiety Disorders; Depression; Lung Diseases, Interstitial

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

The data captured was deemed unreliable due to the turnover among study personnel and insufficient personnel to administer the questionnaires accurately.

Results Point of Contact

• Title: Neil MacIntyre
• Organization: Duke University Medical Center

macin001@mc.duke.edu

919 681 2720

Study Officials

• Anne Mathews, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 27, 2016
• Study Start: August 1, 2016
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2019
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2021-09

Locations

US (1)