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Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00151372
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : January 11, 2010
Last Update Posted : January 11, 2010
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Weill Medical College of Cornell University

Brief Summary:
Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major depression, a condition that contributes to suffering but also to poor treatment adherence leading to increased disability and morbidity. This study investigates the effectiveness of a care management intervention aimed at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability at a 28-week follow-up period.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Major Depression Behavioral: Treatment Adherence Intervention Behavioral: Enhanced Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Effectiveness in Depressed Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : March 2002
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Adherence Intervention
In the Treatment Adherence Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease treatment adherence and to help the participant overcome those obstacles.
Behavioral: Treatment Adherence Intervention
The care management intervention aims at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability.

Active Comparator: Enhanced Care
In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
Behavioral: Enhanced Care
For subjects in the Enhanced Care group, physicians providing aftercare will receive no clinical instructions by the research team, but will be informed in writing of the patients' diagnosis and will be provided with a copy of the Agency for Health Care Policy and Research (AHCPR) guidelines for the treatment of depression in primary care with an addendum updating the tables describing Selective Serotonin Reuptake Inhibitors (SSRI) side effect and dosage profiles. The investigators expect that these physicians will continue to base their practice on clinical judgment about how best to treat depression in chronic obstructive pulmonary disease patients.




Primary Outcome Measures :
  1. Composite Antidepressant Score Scale (CAD) [ Time Frame: 28 Weeks ]
    The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0.


Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: 28 Weeks ]
    The 17-item Hamilton Depression Rating Scale (HDRS) measures the severity of a depressive episode: the higher the score, the more severe the depression. The Best value is 0 and the Worst value is 52.



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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic obstructive pulmonary disease by American Thoracic Society criteria
  • Major depression by DSM-IV criteria
  • 17-item Hamilton score >14
  • English speaking

Exclusion Criteria:

  • Inability to give informed consent
  • MiniMental score <24
  • Aphasia
  • Nursing home placement after discharge

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151372


Locations
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United States, New York
Helen Hayes Hospital
West Haverstraw, New York, United States, 10993
Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
Weill Medical College of Cornell University
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: George S Alexopoulos, MD Weill Medical College of Cornell University
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Responsible Party: George S. Alexopoulos, M.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00151372    
Other Study ID Numbers: 0201005319
R01HL071992-05 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2005    Key Record Dates
Results First Posted: January 11, 2010
Last Update Posted: January 11, 2010
Last Verified: December 2009
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases