Treatment for Post-Stroke Depression

Stroke Clinical Trial

Official title:

Treatment for Post-Stroke Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029172
• Other study ID #: 9903-06
• Status: Completed
• Phase: Phase 4
• Start date: May 1999
• Est. completion date: December 2005

Study information

• Verified date: December 2009
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

• No severe language or cognitive deficits,

• life expectancy of at least 9 months, and

• willingness to participate.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Stroke

Intervention

Other:
• case management

Locations

Country	Name	City	State
United States	Indiana University Hospital, 550 N. University Blvd.	Indianapolis	Indiana
United States	Methodist Hospital of Indiana, 1601 N. Capitol	Indianapolis	Indiana
United States	Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street	Indianapolis	Indiana
United States	Wishard Memorial Hospital, 1001 W. 10th Street	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Williams LS, Bakas T, Brizendine E, Plue L, Tu W, Hendrie H, Kroenke K. How valid are family proxy assessments of stroke patients' health-related quality of life? Stroke. 2006 Aug;37(8):2081-5. doi: 10.1161/01.STR.0000230583.10311.9f. Epub 2006 Jun 29. — View Citation

Williams LS, Brizendine EJ, Plue L, Bakas T, Tu W, Hendrie H, Kroenke K. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke. 2005 Mar;36(3):635-8. doi: 10.1161/01.STR.0000155688.18207.33. Epub 2005 Jan 27. — View Citation

Williams LS, Kroenke K, Bakas T, Plue LD, Brizendine E, Tu W, Hendrie H. Care management of poststroke depression: a randomized, controlled trial. Stroke. 2007 Mar;38(3):998-1003. doi: 10.1161/01.STR.0000257319.14023.61. Epub 2007 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Twelve Week Depression Outcomes	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.	Twelve week