Treatment for Post-Stroke Depression

January 19, 2023 updated by: Indiana University
The purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • 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
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse Case management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Twelve Week Depression Outcomes
Time Frame: Twelve week

Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%.

The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale.

Twelve week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

January 8, 2002

First Submitted That Met QC Criteria

January 8, 2002

First Posted (Estimate)

January 9, 2002

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

December 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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