Treatment for Post-Stroke Depression

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00029172
First received: January 8, 2002
Last updated: December 31, 2009
Last verified: December 2009
  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
Other: case management
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment for Post-Stroke Depression

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Twelve Week Depression Outcomes [ Time Frame: Twelve week ] [ Designated as safety issue: No ]

Enrollment: 188
Study Start Date: May 1999
Study Completion Date: December 2005
Arms Assigned Interventions
Experimental: Nurse Case management Other: case management

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Linda Williams, M.D., Roudebush VA Medical Center
ClinicalTrials.gov Identifier: NCT00029172     History of Changes
Other Study ID Numbers: 9903-06
Study First Received: January 8, 2002
Results First Received: August 3, 2009
Last Updated: December 31, 2009
Health Authority: United States: Federal Government

Keywords provided by Indiana University:
stroke
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stroke
Cerebral Infarction
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014