Back to resultsTreatment for Post-Stroke Depression
Primary Purpose
Stroke, Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
case management
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, depression
Eligibility Criteria
No severe language or cognitive deficits, life expectancy of at least 9 months, and willingness to participate.
Sites / Locations
- Indiana University Hospital, 550 N. University Blvd.
- Methodist Hospital of Indiana, 1601 N. Capitol
- Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street
- Wishard Memorial Hospital, 1001 W. 10th Street
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nurse Case management
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00029172
Brief Title
Treatment for Post-Stroke Depression
Official Title
Treatment for Post-Stroke Depression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Depression
Keywords
stroke, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nurse Case management
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
case management
Primary Outcome Measure Information:
Title
Twelve Week Depression Outcomes
Description
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.
Time Frame
Twelve week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
No severe language or cognitive deficits,
life expectancy of at least 9 months, and
willingness to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Williams, M.D.
Organizational Affiliation
Roudebush VA Medical Center Health Services Research and Development 11H
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital, 550 N. University Blvd.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hospital of Indiana, 1601 N. Capitol
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wishard Memorial Hospital, 1001 W. 10th Street
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15677576
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.
Results Reference
background
PubMed Identifier
16809575
Citation
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.
Results Reference
background
PubMed Identifier
17303771
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.
Results Reference
result
Learn more about this trial
Treatment for Post-Stroke Depression
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