Background/Purpose: Post-stroke depression (PSD) occurs within the first 6 months post-stroke in at least 30% of stroke survivors and is associated with increased stroke morbidity and mortality. Despite the availability of antidepressant treatments, only a few small randomized trials of PSD treatment have been published. The objectives of this NINDS-funded study are to: 1) conduct a randomized clinical trial of post-stroke depression treatment, 2) compare outcomes in depressed (N=240) and non-depressed (N=240) stroke survivors, and 3) evaluate the impact of PSD on family caregivers (CG). Methods: AIM is an NINDS-funded PROBE-designed trial comparing a modified case-management intervention vs. usual care in patients with PSD. Ischemic stroke survivors are enrolled at 1-2 months post-stroke from 4 Indianapolis hospitals. Depression is assessed using the Patient Health Questionnaire (PHQ), Hamilton Depression Inventory (HAMD) and DSM-IV-based Structured Clinical Interview for Depression. QOL is assessed with the SS-QOL. Depressed patients (DEP) are randomized to the 12-week AIM intervention vs. usual care. The intervention includes patient Activation/education about PSD, Initiating antidepressant treatment, and bimonthly Monitoring of PSD symptoms and medication use. Medication treatment consists of one of 2 SSRIs or a serotonin-norepinephrine reuptake inhibitor. Primary PSD, QOL and stroke outcomes are measured at 12 weeks. Long-term depression, QOL and utilization outcomes are assessed at 9 months. Results: 269 patients (mean age 61, 52% female, 38% African American) and 159 CGs (mean age 51, 74% female) have been enrolled. Baseline scores in the DEP (N=127) and non-depressed (ND, N=142) groups are: DEP: PHQ 14.0, HAMD 18.7, SS-QOL 3.4; ND: PHQ 3.7, SSQOL 4.2. 52% of the depressed group meet criteria for major depression. 17% of intervention patients have changed their initial antidepressant due to side effects. 11% of usual care patients received an antidepressant prescription during the 12-week intervention. 18% of family CGs screened positive for depression at baseline and half of these had major depression. Conclusions: Patients with PSD have worse depression symptom scores and worse QOL than non-depressed patients. Depression is also prevalent in family CGs of stroke survivors. Study enrollment is planned through December 2004.