Treatment for Post-Stroke Depression

This study is ongoing, but not recruiting participants.

First Received: January 8, 2002 Last Updated: October 22, 2008 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

U.S. FDA Resources

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

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:

Linda Williams, M.D.

Roudebush VA Medical Center Health Services Research and Development 11H

More Information

Publications:

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.

Williams LS, Brizendine EJ, Plue L, Bakas T, Tu W, Hendrie H, Kroenke K. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke. 2005 Mar;36(3):635-8. Epub 2005 Jan 27.

Williams LS, Bakas T, Brizendine E, Plue L, Tu W, Hendrie H, Kroenke K. How valid are family proxy assessments of stroke patients' health-related quality of life? Stroke. 2006 Aug;37(8):2081-5. Epub 2006 Jun 29.

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

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

stroke
depression

Additional relevant MeSH terms:

Depression
Cerebral Infarction
Stroke
Nervous System Diseases
Psychotropic Drugs
Vascular Diseases
Central Nervous System Diseases
Depressive Disorder
Brain Diseases
Cerebrovascular Disorders

Pharmacologic Actions
Behavioral Symptoms
Mental Disorders
Therapeutic Uses
Mood Disorders
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 05, 2009