Obsessive-compulsive Disorder
Conditions
Brief summary
Up to 40% of Obsessive-Compulsive Disorder (OCD) patients do not respond to conventional treatments (medications or behavior therapy). For some of them, a neurosurgical treatment can be indicated. A previous study, employing bilateral double-shot ventral capsular/ventral striatal (VC/VS) Gamma capsulotomy (GVC) for OCD has shown that this radiosurgical technique is potentially efficacious and relatively safe. However, a few patients may develop complications associated to radionecrosis (eg., brain cysts) in a long-term follow-up, which are probably associated to lesion volumes. Another study, with the preliminary results of smaller VC/VS Gamma capsulotomy lesions has suggested that this procedure is safe and remains efficacious. Our aim is to investigate the efficacy and safety profiles of smaller, single-shot VC/VS Gamma capsulotomy for OCD. This study will support the development of a future double-blind, randomized clinical trial of single-shot VC/VS Gamma capsulotomy.
Interventions
PROCEDUREGamma Ventral Capsulotomy
Sponsors
Hospital do Coracao
Brown University
University of Sao Paulo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A DSM-V diagnosis of OCD as the main diagnostic entity. If comorbid axis I or II disorders are present, OCD symptoms are the most troublesome among disorders. * Age range between 18 and 65 years old. * At least 5 years of OCD symptoms. * Yale-Brown Obsessive-Compulsive Scale (YBOCS) scores greater than 26 (or greater than 13, for isolated obsessions or compulsions). * Refractoriness criteria fulfilled. * To be accepted by the best estimate method as a treatment refractory patient. It consists in the careful examination of each patient's history by two OCD specialists, so as to confirm refractoriness status. Refractoriness criteria: * At least 3 serotonin reuptake inhibitors (selective or not) have been tried before. One of these trials must have included clomipramine. All drugs were used for a minimum of 12 weeks, at the maximum doses or the maximally tolerated doses. * Previous participation in a cognitive behavior therapy program (exposure and response prevention), for a minimum of 20 hours' time; or participation for some time, without subsequent adherence, due to severe OCD symptoms, and acceptance of the independent review board. * YBOCS scores reductions after adequate drug therapy and psychotherapy not better than 25 %, or confirmation of no clinical improvements by the mental health professionals who were responsible for the treatments of the patient. * By the end of adequately conducted pharmacological trials, Clinical Global Impression (CGI) scores not better than minimal improvement. * Previous use of at least two antidepressant augmentation strategies (such as the association of a typical or atypical antipsychotic, another serotonin reuptake inhibitor, a benzodiazepine, an anticonvulsant or an antiglutamatergic medication), in adequate doses for a sufficient period of time, without satisfactory responses.
Exclusion criteria
* Less than 18 years or more than 65 years of age. * Past history of head injury, with posttraumatic amnesia. * Past or general medical condition, or neurological illness with brain compromise (severe and in active phase) * History of physiological effects of a substance, as determinant of psychopathological symptoms, or cumulative signs of alcohol or drug abuse in the Central Nervous System (such cortical atrophy), confirmed by a neuroimaging scan. * Pregnancy or lactation. * Refusal to participate in radiosurgical procedures. * Refusal to sign the Patient Information and Consent Form, or refusal to take part in this study. * History of mental retardation and/or being unable to understand the Patient Information and Consent Form, confirmed by poor performance on neuropsychological tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | up to 10 years |
Countries
Brazil
Contacts
Primary ContactAntonio C Lopes, MD, PhD
Backup ContactMarines A Joaquim, RN
Outcome results
None listed