title: Gamma ventral capsulotomy for obsessive-compulsive disorder: a randomized clinical trial.
abstract: 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.
  
  
  
  To determine the efficacy and safety of a radiosurgery (gamma ventral capsulotomy [GVC]) for intractable OCD.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  clinicaltrials.gov Identifier: NCT01004302.
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Antonio C
authors: AC
authors: Lopes
authors: Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, Rhode Island.
authors: Benjamin D
authors: BD
authors: Greenberg
authors: The Institute of Neurological Radiosurgery, Hospital Santa Paula, São Paulo, Brazil.
authors: Miguel M
authors: MM
authors: Canteras
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Marcelo C
authors: MC
authors: Batistuzzo
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Marcelo Q
authors: MQ
authors: Hoexter
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: André F
authors: AF
authors: Gentil
authors: Statistics Department of the Mathematics and Statistics Institute of the University of São Paulo, São Paulo, Brazil.
authors: Carlos A B
authors: CA
authors: Pereira
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Marinês A
authors: MA
authors: Joaquim
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Maria E
authors: ME
authors: de Mathis
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Carina C
authors: CC
authors: D'Alcante
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Anita
authors: A
authors: Taub
authors: Department of Radiology, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Douglas G
authors: DG
authors: de Castro
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Lucas
authors: L
authors: Tokeshi
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Leonardo A N P C
authors: LA
authors: Sampaio
authors: Department of Radiology, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Cláudia C
authors: CC
authors: Leite
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Roseli G
authors: RG
authors: Shavitt
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Juliana B
authors: JB
authors: Diniz
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Geraldo
authors: G
authors: Busatto
authors: Department of Neurosurgery, The Warren Alpert Medical School of Brown University, Providence, Rhode Island.
authors: Georg
authors: G
authors: Norén
authors: Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, Rhode Island6Department of Neurosurgery, The Warren Alpert Medical School of Brown University, Providence, Rhode Island.
authors: Steven A
authors: SA
authors: Rasmussen
authors: Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
authors: Eurípedes C
authors: EC
authors: Miguel
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020772:Internal Capsule / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009771:Obsessive-Compulsive Disorder / Q000601:surgery*; D011569:Psychiatric Status Rating Scales; D016634:Radiosurgery / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult