We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Treatment for Post-Stroke Depression

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: NCT00029172
Recruitment Status : Completed
First Posted : January 9, 2002
Results First Posted : January 28, 2010
Last Update Posted : January 28, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Stroke Depression Other: case management Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment for Post-Stroke Depression
Study Start Date : May 1999
Study Completion Date : December 2005
Arms and Interventions

Arm Intervention/treatment
Experimental: Nurse Case management Other: case management

Outcome Measures

Primary Outcome Measures :
  1. Twelve Week Depression Outcomes [ Time Frame: Twelve week ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • No severe language or cognitive deficits,
  • life expectancy of at least 9 months, and
  • willingness to participate.
Contacts and Locations

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): NCT00029172

United States, Indiana
Indiana University Hospital, 550 N. University Blvd.
Indianapolis, Indiana, United States, 46202
Methodist Hospital of Indiana, 1601 N. Capitol
Indianapolis, Indiana, United States, 46202
Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street
Indianapolis, Indiana, United States, 46202
Wishard Memorial Hospital, 1001 W. 10th Street
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Principal Investigator: Linda Williams, M.D. Roudebush VA Medical Center Health Services Research and Development 11H
More Information

Responsible Party: Linda Williams, M.D., Roudebush VA Medical Center
ClinicalTrials.gov Identifier: NCT00029172     History of Changes
Other Study ID Numbers: 9903-06
First Posted: January 9, 2002    Key Record Dates
Results First Posted: January 28, 2010
Last Update Posted: January 28, 2010
Last Verified: December 2009

Keywords provided by Indiana University:

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