A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression

• Published in: Biological psychiatry (1969) Vol. 78; no. 4; pp. 240 - 248
• Main Authors: Dougherty, Darin D, Rezai, Ali R, Carpenter, Linda L, Howland, Robert H, Bhati, Mahendra T, O’Reardon, John P, Eskandar, Emad N, Baltuch, Gordon H, Machado, Andre D, Kondziolka, Douglas, Cusin, Cristina, Evans, Karleyton C, Price, Lawrence H, Jacobs, Karen, Pandya, Mayur, Denko, Timothey, Tyrka, Audrey R, Brelje, Tim, Deckersbach, Thilo, Kubu, Cynthia, Malone, Donald A
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 15-08-2015
• Subjects: Adult; Aged; Chronic Disease; DBS; Deep Brain Stimulation; Depressive Disorder, Major - therapy; Depressive Disorder, Treatment-Resistant - therapy; Female; Humans; Internal Capsule - physiopathology; Major depression; Male; Middle Aged; Psychiatric Status Rating Scales; Psychiatry; TRD; Treatment Outcome; Treatment resistant depression; Ventral capsule/ventral striatum; Ventral Striatum - physiopathology; Young Adult; DBS; Treatment resistant depression; Deep brain stimulation; Major depression; Ventral capsule/ventral striatum; TRD
• ISSN: 0006-3223; 1873-2402
• DOI: 10.1016/j.biopsych.2014.11.023

Abstract Background Multiple open-label trials of deep brain stimulation (DBS) for treatment-resistant depression (TRD), including those targeting the ventral capsule/ventral striatum target, have shown encouraging response rates. However, no randomized controlled trials of DBS for TRD have been published. Methods Thirty patients with TRD participated in a sham-controlled trial of DBS at the ventral capsule/ventral striatum target for TRD. Patients were randomized to active versus sham DBS treatment in a blinded fashion for 16 weeks, followed by an open-label continuation phase. The primary outcome measure was response, defined as a 50% or greater improvement on the Montgomery–Åsberg Depression Rating Scale from baseline. Results There was no significant difference in response rates between the active (3 of 15 subjects; 20%) and control (2 of 14 subjects; 14.3%) treatment arms and no significant difference between change in Montgomery–Åsberg Depression Rating Scale scores as a continuous measure upon completion of the 16-week controlled phase of the trial. The response rates at 12, 18, and 24 months during the open-label continuation phase were 20%, 26.7%, and 23.3%, respectively. Conclusion The results of this first randomized controlled study of DBS for the treatment of TRD did not demonstrate a significant difference in response rates between the active and control groups at the end of the 16-week controlled phase. However, a range of 20% to 26.7% of patients did achieve response at any time during the open-label continuation phase. Future studies, perhaps utilizing alternative study designs and stimulation parameters, are needed.