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
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Depression
Drug: Advair diskus
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD

Resource links provided by NLM:


Further study details as provided by Valley Medical Research:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COPD, ECF residents, Advair diskus
open label treatment with Advair diskus in COPD patients
Drug: Advair diskus
Advair diskus 50/250 1 inhalation bid for 16 weeks

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

Ages Eligible for Study:   18 Years to 94 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974246

Locations
United States, Florida
Geriatric Medical Associates
Brooksville, Florida, United States, 34601
United States, Ohio
Valley Medical Research
Centerville, Ohio, United States, 45459
Sponsors and Collaborators
Valley Medical Research
Investigators
Principal Investigator: Meenakshi Patel, MD Valley Medical Research
  More Information

No publications provided

Responsible Party: Meenakshi Patel, MD, Valley Medical Research
ClinicalTrials.gov Identifier: NCT00974246     History of Changes
Other Study ID Numbers: DISK-02
Study First Received: September 8, 2009
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Valley Medical Research:
COPD
Depression
Nursing Home

Additional relevant MeSH terms:
Depression
Depressive Disorder
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Diseases
Fluticasone, salmeterol drug combination
Albuterol
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Tocolytic Agents
Reproductive Control Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents

ClinicalTrials.gov processed this record on July 24, 2014