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

Duke University13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

COPD

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: visit 1(baseline), visit 4 (week 4), visit 6 (week 12)

Secondary Outcomes

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). Scores range from 0 to 30, with higher scores indicating a higher quality of life.

Time frame: 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)

To monitor changes in perceived stress, patients will complete the General Health Questionnaire-12 (GHQ-12). Scores range from 0 to 36, with higher scores indicating greater distress.

Time frame: 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)

Scores on the HADS range from 0-21, with higher scores indicating more severe of symptoms.

Time frame: 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

Scores on the Anxiety Inventory for Respiratory Disease (AIR) range from 0-30, with higher scores indicating more symptoms.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes