Electrodes in the braindEthical criteria for research and treatment with deep brain stimulation for neuropsychiatric disorders Matthis Synofzik a , Thomas E. Schlaepfer b,c a Department for Neurodegenerative Diseases, Hertie-Institute for Clinical Brain Research, University of Tu ¨bingen, Germany b Department of Psychiatry and Psychotherapy, University Hospital, Bonn, Germany c Departments of Psychiatry and Mental Health, The Johns Hopkins University, Baltimore, Maryland Background Deep brain stimulation (DBS) has been used for neuropsychiatric disorders in clinical and research settings for almost 50 years now. Recent evidence demonstrates some efficacy in treating obsessive-compulsive disorder and major depression in patients refractory to other treatment modalities beyond single case reports. This has led to a considerable surge of clinical and commercial interest in DBS for psychiatric indications. Because of the high vulnerability of psychiatric patients, the lack of extensive short- and long- term data about effectiveness and the rapid spread of questionable indications this new field in psychiatry requires ethical criteria that can be applied to both research and clinical decision-making. Objective and Methods We here present an evidence-based systematic ethical analysis of psychiatric DBS using the criteria of beneficence, nonmaleficence, and autonomy. Results and Conclusions The proposed criteria are helpful in analyzing empirical evidence, informing research investigations and guiding clinical decision-making. This will prepare the ground for ethically justified, empirically comprehensive DBS in this highly vulnerable population and allow stringent future societal discussions about its legitimation. Ó 2011 Elsevier Inc. All rights reserved. Keywords deep brain stimulation; neuroethics; major depression Setting the Stage High-frequency electrical deep brain stimulation (DBS) of specific brain circuits has gained increasing acceptance in treatment of several neurologic disorders because of its high effectiveness anddcompared with classical ablative neuro- surgical interventionsdits less invasive, largely reversible, and adjustable features. 1 First evidence for efficacy has also Dr. Schlaepfer received limited support for an Investigator Initiated Study on DBS in resistant major depression from Medtronic Inc, a manufacturer of DBS equipment between 2004 and 2007. Correspondence: Thomas E. Schlaepfer, MD, Department of Psychiatry/ University Hospital, Sigmund-Freud-Strasse 25, 53105 Bonn, Germany. E-mail address: schlaepf@jhmi.edu Submitted July 27, 2009; revised January 12, 2010. Accepted for publication January 14, 2010. 1935-861X/$ - see front matter Ó 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.brs.2010.03.002 Brain Stimulation (2011) 4, 7–16 www.brainstimjrnl.com