Clinical trial NCT02813447: Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)
Official title: Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD
Anxiety
Depression
Stress
Interstitial Lung Disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in 6MW distance
timeFrame: visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).
measure: Change in dyspnea scores, as measured by UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB)
timeFrame: visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
measure: Change in quality of life, as measured by Ferrans & Powers Quality of Life Index - Pulmonary version (QOL)
timeFrame: visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
Secondary outcomes:
measure: Change in perceived stress, as measured by General Health Questionnaire-12 (GHQ-12)
timeFrame: visit 1 (baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
measure: Change in anxiety, as measured by Hamilton Anxiety and Depression Scale (HADS)
timeFrame: visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
measure: Change in anxiety, as measured by Anxiety Inventory for Respiratory Disease (AIR)
timeFrame: visit 1(baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
measure: Change in depression, as measured by Hamilton Anxiety and Depression Scale (HADS)
timeFrame: visit 1 (baseline), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12)
measure: 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
timeFrame: visit 2 (week 2), visit 3 (week 3), visit 4 (week 4)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Pulmonary Rehabilitation
state: North Carolina
Study officials:
affiliation: Duke University
name: Anne Mathews, MD
role: PRINCIPAL_INVESTIGATOR
References: