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The Effect on Depressive Symptoms in ECF Residents With COPD

NCT ID: NCT00974246

Last Updated: 2016-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Depression

Keywords

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COPD Depression Nursing Home

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COPD, ECF residents, Advair diskus

open label treatment with Advair diskus in COPD patients

Group Type EXPERIMENTAL

Advair diskus

Intervention Type DRUG

Advair diskus 50/250 1 inhalation bid for 16 weeks

Interventions

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Advair diskus

Advair diskus 50/250 1 inhalation bid for 16 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

94 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valley Medical Research

OTHER

Sponsor Role lead

Responsible Party

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Meenakshi Patel, MD

Meenakshi Patel, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meenakshi Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Medical Research

Locations

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Geriatric Medical Associates

Brooksville, Florida, United States

Site Status

Valley Medical Research

Centerville, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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DISK-02

Identifier Type: -

Identifier Source: org_study_id