The Effect on Depressive Symptoms in ECF Residents With COPD

Depression Clinical Trial

— DISK-02  

Official title:

The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974246
• Other study ID #: DISK-02
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2009
• Last updated: June 30, 2015
• Start date: October 2009
• Est. completion date: July 2011

Study information

• Verified date: June 2015
• Source: Valley Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 94 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Depression
• Depressive Disorder
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Advair diskus
Advair diskus 50/250 1 inhalation bid for 16 weeks

Locations

Country	Name	City	State
United States	Geriatric Medical Associates	Brooksville	Florida
United States	Valley Medical Research	Centerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Valley Medical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.	16 weeks	No
Primary	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.	FEC is Forced Expiratory Capacity and FVC is Forced Vital Capacity. The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.	16 weeks	No
Primary	Pulmonary Function FEC/FVC Ratio at 16 Weeks	To measure whether pulmonary function, determined by the ratio between FEC (Forced Expiratory Capacity) and FVC (Forced Vital Capacity), improved during 16 weeks of Advair Diskus administration.	16 weeks	No