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Clinical Trials/NCT00029172
NCT00029172
Completed
Phase 4

Treatment for Post-Stroke Depression

Indiana University4 sites in 1 country188 target enrollmentMay 1999

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Stroke
Sponsor
Indiana University
Enrollment
188
Locations
4
Primary Endpoint
Twelve Week Depression Outcomes
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1999
End Date
December 2005
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Study Sites (4)

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