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JAMA Psychiatry. 2014 Sep;71(9):1066-76. doi: 10.1001/jamapsychiatry.2014.1193.

Gamma ventral capsulotomy for obsessive-compulsive disorder: a randomized clinical trial.

Author information

1
Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
2
Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, Rhode Island.
3
The Institute of Neurological Radiosurgery, Hospital Santa Paula, São Paulo, Brazil.
4
Statistics Department of the Mathematics and Statistics Institute of the University of São Paulo, São Paulo, Brazil.
5
Department of Radiology, University of São Paulo School of Medicine, São Paulo, Brazil.
6
Department of Neurosurgery, The Warren Alpert Medical School of Brown University, Providence, Rhode Island.
7
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.

Abstract

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.

[Indexed for MEDLINE]
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