Efficacy and Adverse Events of Bilateral Single-shot VC/VS Gamma Capsulotomy for OCD: a Pilot Study
NCT ID: NCT02433886
Last Updated: 2015-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
5 participants
INTERVENTIONAL
2014-12-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gamma Ventral Capsulotomy
Gamma Ventral Capsulotomy
Interventions
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Gamma Ventral Capsulotomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Hospital do Coracao
OTHER
Brown University
OTHER
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Antonio Carlos Lopes
Antonio Carlos Lopes MD, PhD
Locations
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OCD Clinics (PROTOC), Department of Psychiatry, University of Sao Paulo General Hospital
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GammaOCD_IPq_HCor
Identifier Type: -
Identifier Source: org_study_id
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