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

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ClinicalTrials.gov Identifier: NCT02813447
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment Phase
COPD Anxiety Depression Stress Interstitial Lung Disease Drug: Sertraline Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sertraline

Arm Intervention/treatment
Active Comparator: 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.
Drug: Sertraline
Placebo Comparator: 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.
Drug: Placebo



Primary Outcome Measures :
  1. 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).

  2. 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 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), 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). Patients will complete this at all visits (1-6).

  3. Change in quality of life, as measured by Ferrans & Powers Quality of Life Index - Pulmonary version (QOL) [ 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) ]
    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 :
  1. Change in perceived stress, as measured by 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) ]
    To monitor changes in perceived stress, patients will complete the General Health Questionnaire-12 (GHQ-12).

  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. Tolerability [ Time Frame: visit 2 (week 2), visit 3 (week 3), visit 4 (week 4) ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813447


Contacts
Contact: Anne M Mathews, MD 919-684-8111 anne.mathews@dm.duke.edu
Contact: Heather Kuehn 919-479-0719 heather.kuehn@duke.edu

Locations
United States, North Carolina
Duke Pulmonary Rehabilitation Recruiting
Durham, North Carolina, United States, 27705
Contact: Neil MacIntyre, MD    919-660-6628    neil.macintyre@dm.duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Anne Mathews, MD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02813447     History of Changes
Other Study ID Numbers: Pro00071349
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Respiratory Tract Diseases
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs