Abstract

Participants in DBS clinical trials for major depressive and other psychiatric disorders may not have access to post-trial neuromodulation. Some commentators have claimed that this would be unfair to trial participants and effectively abandon them. Continued access to these devices could be justified only if there were a statistically significant difference in outcomes between active and sham stimulation and participants responded positively to active DBS. Clinicians and investigators have post-trial obligations to provide appropriate care and psychosocial support to patients and trial participants. Depending on trial outcomes and patient responses, lack of access to continued DBS may not be unfair to them or a form of abandonment.

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