AIM
AIM: A Randomized Trial of Treatment for Post-Stroke Depression
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Status:
Trial complete. Preliminary results presented in February 2006.
Purpose:
To evaluate the impact of post-stroke depression on patient outcome, to determine whether Activate-Initiate-Monitor (AIM), a modified case-management technique, has any advantage over traditional management of depressed patients, and to gauge the effect of post-stroke depression on caregivers and family members.
Interventions:
Activate-Initiate-Monitor (AIM) intervention
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.
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Antidepressant agents
Category includes all drugs used for treatment of depression.
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Location(s):
Indianapolis, Indiana, U.S.A.
Year Started:
2002
Year Finished:
2005
Year Presented:
2006
Design:
Randomized, single-blind, multicenter study.
Inclusion Criteria
Patients who are 1-2 months post-stroke, who have a life expectancy of at least 9 months, and who have no severe language or cognitive deficits are eligible for the study.
Patient Involvement:
Eligible patients are screened for depression 1-2 months post-stroke. Depressed patients are case-matched with non-depressed patients, and subsequently randomized into AIM and control treatment groups. The AIM group will receive education concerning post-stroke depression, antidepressant drugs (one of two SSRI's, or a serotonin-norepinephrine reuptake inhibitor), and monitoring for side effects, drug efficacy, and compliance. The control group will receive standard treatment for depression. All patients will be evaluated for depression, quality of life, and stroke outcome, on the same schedule. Family members and caregivers will also be screened for depression.
Primary Outcome:
12-week and 9-month post-stroke depression (measured with the Patient Health Questionnaire (PHQ), Hamilton Depression Inventory (HAMD), and a DSM-IV-based structured clinical interview), quality of life (assessed by the SS-QOL), and stroke outcomes.
Results:
Interim results:
133 patients (mean age 61, 51% female) and 66 CGs (mean age 52, 74% female) have been enrolled. Baseline scores in the DEP (N=63) and non-depressed (ND, N=70) groups are: DEP: PHQ 13.6, HAMD 18.4, SS-QOL 3.4; ND: PHQ 4.0, SS-QOL 4.2. Three patients have changed medication due to side effects. 35% of family CGs screened positive for depression at study entry.
Source of Information:
Presented at the 29th International Stroke Conference [February 2004].
Correspondence with trial coordinator [July 2005].
Presented at the 2006 International Stroke Conference [February 2006].
Presented secondary analysis of data at the 2009 International Stroke Conference [February 2009].
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Web Links and Publications:
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This information last updated on: 3/24/2009
Reviewed on: 03/24/2009.
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