Clinical trial NCT00974246: The Effect on Depressive Symptoms in ECF Residents With COPD
Official title: The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Depression
Keywords: COPD
Depression
Nursing Home
Lead sponsor: Valley Medical Research
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 94
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of treatment with Advair Diskus on depression using the Cornell depression scale in COPD patients in the nursing home.

Detailed description: We are studying 35 residents in the ECF with a diagnosis of COPD. We are evaluating them for depressive symptoms using the Cornell Depression Scale and the MDS 3.0 section D. We are selecting patients who are not currently on treatment with Advair and starting them on Advair Diskus50/250 1 inhalation bid for a period of 16 weeks and reassessing the Cornell Depression SCale and MDS3.0 section D looking for any changes. We are also going to measure FEV1 and FVC using spirometry before treatment and at the end of 16 weeks. This is a pilot study. The numbers are not necessarily adequate to achieve statistical difference-we are looking for trends.

Eligibility criteria: Inclusion Criteria:

* Adult men and women nursing home residents up to age 95
* Stated diagnosis of COPD or FEV1/FVC \<0.7 or being treated with an anticholinergic
* Presence of depressive symptoms as measured on MDS 3.0 Section D SUM
* Free from conditions likely to be fatal within six months
* Able to read or understand English
* Able and willing to provide informed consent or has a guardian/LAR who can provide informed consent

Exclusion Criteria:

* Currently pregnant
* Unable to read and understand English
* Free from conditions likely to be fatal within six months
* Enrolled in hospice
* New treatment with antidepressant within the last 90 days.
* Current or recent use (within the last 90 days) of Advair Diskus
* Unwilling or unable to provide informed consent
* Expected to be discharged within 3 months

Primary outcomes:
measure: To Determine the Effect of Treating COPD Patients With Advair Diskus for 16 Weeks on the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0
timeFrame: 16 weeks
measure: To Determine if Changes in Pulmonary Function (FEC/FVC) Were Associated With a Reduction in Depression as Assessed by Using the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0 During Advair Diskus Treatment.
timeFrame: 16 weeks
measure: Pulmonary Function FEC/FVC Ratio at 16 Weeks
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brooksville
country: United States
facility: Geriatric Medical Associates
state: Florida
city: Centerville
country: United States
facility: Valley Medical Research
state: Ohio
Study officials:
affiliation: Valley Medical Research
name: Meenakshi Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: