The Effect on Depressive Symptoms in ECF Residents With COPD (DISK-02)
This study has been completed.
Sponsor:
Valley Medical Research
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
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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
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 May 23, 2013