Treatment for Post-Stroke Depression

Phase 4

Completed

• Conditions: Stroke; Depression
• Interventions: Other: case management

• Registration Number: NCT00029172
• Lead Sponsor: Indiana University

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.

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 Timeline

• Study Start: 1999-05
• Study First Submitted: 2002-01-08
• Study First Submitted QC: 2002-01-08
• Study First Posted: 2002-01-09
• Study Completion: 2005-12
• Results First Submitted: 2009-08-03
• Status Verified: 2009-12
• Results First Submitted QC: 2009-12-31
• Results First Posted: 2010-01-28
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nurse Case management	case management	-

Primary Outcome Measures

Name	Time	Method
Twelve Week Depression Outcomes	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.

Trial Locations

Locations (4)

Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Hospital, 550 N. University Blvd.; 🇺🇸 Indianapolis, Indiana, United States

Methodist Hospital of Indiana, 1601 N. Capitol; 🇺🇸 Indianapolis, Indiana, United States

Wishard Memorial Hospital, 1001 W. 10th Street; 🇺🇸 Indianapolis, Indiana, United States