Treatment for Post-Stroke Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

January 8, 2002

Last Updated Date

October 22, 2008

Start Date ^ICMJE

May 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Depression severity assessed by the Hamilton Depression scale.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00029172 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Treatment for Post-Stroke Depression

Official Title ^ICMJE

Treatment for Post-Stroke Depression

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind

Condition ^ICMJE

Stroke
Depression

Intervention ^ICMJE

Drug: antidepressants

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

780

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00029172

Responsible Party

Linda Williams, M.D., Roudebush VA Medical Center

Study ID Numbers ^ICMJE

R01NS39571

Study Sponsor ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Linda Williams, M.D.

Roudebush VA Medical Center Health Services Research and Development 11H

Information Provided By

National Institute of Neurological Disorders and Stroke (NINDS)

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP