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OpenTrials
Completed

NCT Number: NCT00029172

Treatment for Post-Stroke Depression

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

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Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University Hospital, 550 N. University Blvd., Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Case management

Other

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
1999
Study completion
2005
First posted
Jan 9, 2002
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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