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Original Investigation |

Gamma Ventral Capsulotomy for Obsessive-Compulsive Disorder:  A Randomized Clinical Trial

Antonio C. Lopes, MD, PhD1; Benjamin D. Greenberg, MD, PhD2; Miguel M. Canteras, MD3; Marcelo C. Batistuzzo, PsyD1; Marcelo Q. Hoexter, MD, PhD1; André F. Gentil, MD1; Carlos A. B. Pereira, PhD4; Marinês A. Joaquim, RN1; Maria E. de Mathis, PsyD1; Carina C. D’Alcante, PsyD, MSc1; Anita Taub, PsyD, MSc1; Douglas G. de Castro, MD5; Lucas Tokeshi, MD1; Leonardo A. N. P. C. Sampaio, MD1; Cláudia C. Leite, MD, PhD5; Roseli G. Shavitt, MD, PhD1; Juliana B. Diniz, MD, PhD1; Geraldo Busatto, MD, PhD1; Georg Norén, MD, PhD6; Steven A. Rasmussen, MD, PhD2,6; Eurípedes C. Miguel, MD, PhD1
[+] Author Affiliations
1Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil
2Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, Rhode Island
3The Institute of Neurological Radiosurgery, Hospital Santa Paula, São Paulo, Brazil
4Statistics Department of the Mathematics and Statistics Institute of the University of São Paulo, São Paulo, Brazil
5Department of Radiology, University of São Paulo School of Medicine, São Paulo, Brazil
6Department of Neurosurgery, The Warren Alpert Medical School of Brown University, Providence, Rhode Island
JAMA Psychiatry. 2014;71(9):1066-1076. doi:10.1001/jamapsychiatry.2014.1193.
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Importance  Select cases of intractable obsessive-compulsive disorder (OCD) have undergone neurosurgical ablation for more than half a century. However, to our knowledge, there have been no randomized clinical trials of such procedures for the treatment of any psychiatric disorder.

Objective  To determine the efficacy and safety of a radiosurgery (gamma ventral capsulotomy [GVC]) for intractable OCD.

Design, Setting, and Participants  In a double-blind, placebo-controlled, randomized clinical trial, 16 patients with intractable OCD were randomized to active (n = 8) or sham (n = 8) GVC. Blinding was maintained for 12 months. After unblinding, sham-group patients were offered active GVC.

Interventions  Patients randomized to active GVC had 2 distinct isocenters on each side irradiated at the ventral border of the anterior limb of the internal capsule. The patients randomized to sham GVC received simulated radiosurgery using the same equipment.

Main Outcomes and Measures  Scores on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and the Clinical Global Impression-Improvement (CGI-I) Scale. Response was defined as a 35% or greater reduction in Y-BOCS severity and “improved” or “much improved” CGI-I ratings.

Results  Three of 8 patients randomized to active treatment responded at 12 months, while none of the 8 sham-GVC patients responded (absolute risk reduction, 0.375; 95% CI, 0.04-0.71). At 12 months, OCD symptom improvement was significantly higher in the active-GVC group than in the sham group (Y-BOCS, P = .046; Dimensional Y-BOCS, P = .01). At 54 months, 2 additional patients in the active group had become responders. Of the 4 sham-GVC patients who later received active GVC, 2 responded by post-GVC month 12. The most serious adverse event was an asymptomatic radiation-induced cyst in 1 patient.

Conclusions and Relevance  Gamma ventral capsulotomy benefitted patients with otherwise intractable OCD and thus appears to be an alternative to deep-brain stimulation in selected cases. Given the risks inherent in any psychiatric neurosurgery, such procedures should be conducted at specialized centers.

Trial Registration  clinicaltrials.gov Identifier: NCT01004302

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Figure 1.
CONSORT Diagram of Sham and Active Treatment Groups
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Figure 2.
Mean (95% CI) Yale-Brown Obsessive-Compulsive Scale Scores for the Sham Treatment and Active Treatment Groups During the First 12 Months of Follow-up (Double-Blind Phase)

P value is for the comparison between each surgical group.

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