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The Effect on Depressive Symptoms in ECF Residents With COPD (DISK-02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meenakshi Patel, MD, Valley Medical Research
ClinicalTrials.gov Identifier:
NCT00974246
First received: September 8, 2009
Last updated: December 19, 2012
Last verified: December 2012
History of Changes

September 8, 2009
December 19, 2012
October 2009
July 2011   (final data collection date for primary outcome measure)
To determine the effect of treating COPD patients with Advair diskus for 16 weeks on the Cornell depression scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00974246 on ClinicalTrials.gov Archive Site
To determine the effect of treatment with Advair diskus on spirometry measure in nursing home residents with COPD [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect on Depressive Symptoms in ECF Residents With COPD
The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD

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.

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.
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Obstructive Pulmonary Disease
  • Depression
Drug: Advair diskus
Advair diskus 50/250 1 inhalation bid for 16 weeks
Experimental: COPD, ECF residents, Advair diskus
open label treatment with Advair diskus in COPD patients
Intervention: Drug: Advair diskus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 94 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00974246
DISK-02
No
Meenakshi Patel, MD, Valley Medical Research
Valley Medical Research
Not Provided
Principal Investigator: Meenakshi Patel, MD Valley Medical Research
Valley Medical Research
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP