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Treatment for Post-Stroke Depression

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00029172
  Purpose

The purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.


Condition Intervention Phase
Stroke
Depression
Drug: antidepressants
Phase III

MedlinePlus related topics:   Depression   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind
Official Title:   Treatment for Post-Stroke Depression

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • Depression severity assessed by the Hamilton Depression scale.

Estimated Enrollment:   780
Study Start Date:   May 1999

Detailed Description:

This trial will compare outcomes in depressed patients receiving the Activate-Initiate-Monitor (AIM) intervention vs. those receiving usual care, and will also compare outcomes in depressed and non-depressed stroke survivors. Patients are screened for depression 1 to 2 months post-stroke. Patients with depression are then randomized to the AIM intervention or control group. Patients without depression are also enrolled at the same time and are matched by hospital site to the depressed patients.

The AIM intervention is a 3-part program consisting of activating or educating the patient and his/her family about post-stroke depression, instituting treatment for depression, and monitoring antidepressant treatments for side effects, efficacy, and compliance. Control patients are evaluated and treated with usual care by their physicians. Patients without depression do not receive the intervention but complete the same assessments on the same schedule as the patients with depression.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • No severe language or cognitive deficits,
  • life expectancy of at least 9 months, and
  • willingness to participate.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029172

Locations
United States, Indiana
Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street    
      Indianapolis, Indiana, United States, 46202
Indiana University Hospital, 550 N. University Blvd.    
      Indianapolis, Indiana, United States, 46202
Methodist Hospital of Indiana, 1601 N. Capitol    
      Indianapolis, Indiana, United States, 46202
Wishard Memorial Hospital, 1001 W. 10th Street    
      Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Investigators
Principal Investigator:     Linda Williams, M.D.     Roudebush VA Medical Center Health Services Research and Development 11H    
  More Information


Publications of Results:
Williams LS, Kroenke K, Bakas T, Plue LD, Brizendine E, Tu W, Hendrie H. Care management of poststroke depression: a randomized, controlled trial. Stroke. 2007 Mar;38(3):998--1003.
 

Other Publications:

Responsible Party:   Roudebush VA Medical Center ( Linda Williams, M.D. )
Study ID Numbers:   R01NS39571
First Received:   January 8, 2002
Last Updated:   October 22, 2008
ClinicalTrials.gov Identifier:   NCT00029172
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
stroke  
depression  

Study placed in the following topic categories:
Depression
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Depressive Disorder
Brain Diseases
Cerebrovascular Disorders
Behavioral Symptoms
Mental Disorders
Mood Disorders
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 03, 2008




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