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Poststroke depression is a prevalent and disabling disorder, yet evidence regarding the effectiveness of treating poststroke depression is inconclusive. Our objective was to determine the effectiveness of the Activate-Initiate-Monitor care management program for the treatment of poststroke depression.We conducted a prospective, randomized, outcome-blinded trial in 188 ischemic stroke survivors identified at the time of admission to one of 4 Indianapolis hospitals. Depression screening and enrollment occurred between 1 and 2 months poststroke. The Activate-Initiate-Monitor intervention was a care management program that included Activation of the patient to recognize depression symptoms and accept treatment, Initiation of an antidepressant medication, and Monitoring and adjusting treatment. Usual care subjects received nondepression-related education and were prescribed antidepressants at the discretion of their provider. The primary outcome measure was depression response, defined as a Hamilton Depression Inventory score <8 (remission) or a decrease from baseline of at least 50% at 12 weeks.Intervention and usual care groups did not differ on any key baseline measures. Both depression response (51% versus 30%, P=0.005) and remission (39% versus 23%, P=0.01) were more likely in the Activate-Initiate-Monitor intervention than in the usual care group. This difference in depression scores was present by 6 weeks and persisted through the 12-week assessment. Serious adverse events did not differ between the 2 groups.The Activate-Initiate-Monitor care management model is significantly more effective than usual care in improving depression outcomes in patients with poststroke depression.