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

Depression Clinical Trial

— SAD-COPD  

Official title:

Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02813447
• Other study ID #: Pro00071349
• Status: Terminated
• Phase: N/A
• Start date: August 2016
• Est. completion date: February 20, 2019

Study information

• Verified date: September 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: February 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• COPD
• Depression
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Stress

Intervention

Drug:
• Sertraline

• Placebo

Locations

Country	Name	City	State
United States	Duke Pulmonary Rehabilitation	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
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). Patients will complete this at all visits (1-6).	visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Primary	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).	visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Secondary	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).	visit 1 (baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Secondary	Change in anxiety, as measured by Hamilton Anxiety and Depression Scale (HADS)		visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Secondary	Change in anxiety, as measured by Anxiety Inventory for Respiratory Disease (AIR)		visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Secondary	Change in depression, as measured by Hamilton Anxiety and Depression Scale (HADS)		visit 1 (baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Secondary	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.	visit 2 (week 2), visit 3 (week 3), visit 4 (week 4)