Clinical trial NCT00029172: Treatment for Post-Stroke Depression
Official title: Treatment for Post-Stroke Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Depression
Keywords: stroke
depression
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2002-01-09
Enrollment: 188
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Twelve Week Depression Outcomes
timeFrame: Twelve week
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital, 550 N. University Blvd.
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital of Indiana, 1601 N. Capitol
state: Indiana
city: Indianapolis
country: United States
facility: Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street
state: Indiana
city: Indianapolis
country: United States
facility: Wishard Memorial Hospital, 1001 W. 10th Street
state: Indiana
Study officials:
affiliation: Roudebush VA Medical Center Health Services Research and Development 11H
name: Linda Williams, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.