Efficacy and Adverse Events of Bilateral Single-shot VC/VS Gamma Capsulotomy for OCD: a Pilot Study

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT02433886
• Date of registration: 29/04/2015
• Prospective Registration: No
• Primary sponsor: University of Sao Paulo General Hospital
• Public title: Efficacy and Adverse Events of Bilateral Single-shot VC/VS Gamma Capsulotomy for OCD: a Pilot Study
• Scientific title: Efficacy and Adverse Events of Bilateral Single-shot Ventral Capsular/Ventral Striatal Gamma Capsulotomy for Obsessive-compulsive Disorder: a Pilot Study
• Date of first enrolment: December 2014
• Target sample size: 5
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02433886
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Brazil

Contacts

• Name: Antonio C Lopes, MD, PhD

• Name: Antonio C Lopes, MD, PhD

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obsessive-compulsive Disorder

Intervention(s)

Procedure: Gamma Ventral Capsulotomy

Primary Outcome(s)

Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Time Frame: up to 10 years]

Secondary ID(s)

GammaOCD_IPq_HCor

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Brown University

Hospital do Coracao