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Only open studies have shown effectiveness of deep brain stimulation (DBS) for treatment-resistant depression. In this two-phase, controlled, industry-sponsored, multicenter study, researchers enrolled 30 (of a planned 208) patients with highly refractory major depression (mean age, 48; mean illness duration, 25 years; mean current episode duration, 11 years; men, 57%). Twenty-nine patients had electroconvulsive therapy, which was ineffective in 66%.
Participants were randomized to a 4-month, double-blind trial of active or sham DBS in the ventral capsule/ventral striatum, followed by open-label, active DBS for all patients. During the double-blind phase, active and sham DBS showed no differences in response rates on a depression rating scal…