Completed

Treatment for Post-Stroke Depression

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What is being tested

case management

Other
Who is being recruted

Behavior+7

+ Behavioral Symptoms

+ Brain Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: May 1999
See protocol details

Summary

Principal SponsorIndiana University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1999

Actual date on which the first participant was enrolled.

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.

Official TitleTreatment for Post-Stroke Depression
Principal SponsorIndiana University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

188 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersDepressionNervous System DiseasesVascular DiseasesStroke

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Indiana University Hospital, 550 N. University Blvd.

Indianapolis, United StatesOpen Indiana University Hospital, 550 N. University Blvd. in Google Maps
Suspended

Methodist Hospital of Indiana, 1601 N. Capitol

Indianapolis, United States
Suspended

Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street

Indianapolis, United States
Suspended

Wishard Memorial Hospital, 1001 W. 10th Street

Indianapolis, United States
Completed4 Study Centers