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Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00151372
First received: September 6, 2005
Last updated: December 7, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention
Pulmonary Disease, Chronic Obstructive
Major Depression
 Behavioral: Treatment Adherence Intervention
Behavioral: Enhanced Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Effectiveness in Depressed Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

Drug Information available for: Serotonin
U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Composite Antidepressant Score Scale (CAD) [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]

Enrollment: 141
Study Start Date: March 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151372

Locations
United States, New York
Helen Hayes Hospital
West Haverstraw, New York, United States, 10993
Weill Medical College of Cornell University
White Plains, New York, United States, 10605
Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: George S Alexopoulos, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: George S. Alexopoulos, M.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00151372     History of Changes
Other Study ID Numbers: 0201005319, R01HL071992-05
Study First Received: September 6, 2005
Results First Received: July 7, 2009
Last Updated: December 7, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Disease
Depression
Depressive Disorder
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Depressive Disorder, Major
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Respiratory Tract Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013