Efficacy and Adverse Events of Bilateral Single-shot VC/VS Gamma Capsulotomy for OCD: a Pilot Study
Primary Purpose
Obsessive-compulsive Disorder
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Gamma Ventral Capsulotomy
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-compulsive Disorder
Eligibility 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.
Sites / Locations
- OCD Clinics (PROTOC), Department of Psychiatry, University of Sao Paulo General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gamma Ventral Capsulotomy
Arm Description
Outcomes
Primary Outcome Measures
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02433886
First Posted
April 29, 2015
Last Updated
May 4, 2015
Sponsor
University of Sao Paulo General Hospital
Collaborators
Hospital do Coracao, Brown University
1. Study Identification
Unique Protocol Identification Number
NCT02433886
Brief Title
Efficacy and Adverse Events of Bilateral Single-shot VC/VS Gamma Capsulotomy for OCD: a Pilot Study
Official Title
Efficacy and Adverse Events of Bilateral Single-shot Ventral Capsular/Ventral Striatal Gamma Capsulotomy for Obsessive-compulsive Disorder: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Hospital do Coracao, Brown University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gamma Ventral Capsulotomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Gamma Ventral Capsulotomy
Other Intervention Name(s)
Ventral capsular/ventral striatal gamma capsulotomy
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame
up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio C Lopes, MD, PhD
Phone
+55-11-26616972
Email
antonioclopesmd@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marines A Joaquim, RN
Phone
+55-11-26616972
Email
majoaquim.protoc@gmail.com
Facility Information:
Facility Name
OCD Clinics (PROTOC), Department of Psychiatry, University of Sao Paulo General Hospital
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01060970
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio C Lopes, MD, PhD
Phone
+55-11-26616972
Email
antonioclopesmd@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Adverse Events of Bilateral Single-shot VC/VS Gamma Capsulotomy for OCD: a Pilot Study
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