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Open studies of deep brain stimulation (DBS) have demonstrated efficacy of the treatment at various locations for severely refractory depression, but controlled studies have had less robust findings. To clarify the discrepancy, Dutch investigators with partial industry support developed a novel, two-stage protocol for 25 patients with treatment-resistant major depression of 15 years' duration (means of 11 medication trials and 2 courses of electroconvulsive therapy).
Electrodes, each with four contacts, were implanted in the ventral anterior limb of the internal capsule. Treatment response was optimized (by varying the voltage and the contacts) during a 52-week, open-label phase that was extended if necessary (e.g., to achieve a stable respo…