Obsessive-compulsive Disorder Clinical Trial
Official title:
Efficacy and Adverse Events of Bilateral Single-shot Ventral Capsular/Ventral Striatal Gamma Capsulotomy for Obsessive-compulsive Disorder: a Pilot Study
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.
Status | Recruiting |
Enrollment | 5 |
Est. completion date | December 2020 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | OCD Clinics (PROTOC), Department of Psychiatry, University of Sao Paulo General Hospital | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Brown University, Hospital do Coracao |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | up to 10 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04934007 -
Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
|
N/A | |
Recruiting |
NCT04071990 -
Family Involvement in CBGT of OCD: a Randomized Controlled Trial
|
N/A | |
Completed |
NCT02541968 -
Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Recruiting |
NCT05391503 -
Light Therapy for Obsessive-compulsive Disorder (OCD)
|
N/A | |
Recruiting |
NCT04539951 -
Pragmatic Trial of Obsessive-compulsive Disorder
|
Phase 2 | |
Completed |
NCT03416504 -
Methods for Managing Intrusive Thoughts
|
N/A | |
Not yet recruiting |
NCT06029738 -
Effect on Obsessive-Compulsive Beliefs and Symptoms of MCT-OCD
|
N/A | |
Recruiting |
NCT02844049 -
European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS
|
N/A | |
Completed |
NCT02911324 -
Cannabinoid Medication for Adults With OCD
|
Phase 1/Phase 2 | |
Terminated |
NCT02909660 -
What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder
|
N/A | |
Completed |
NCT02217995 -
Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients
|
N/A | |
Terminated |
NCT02234011 -
A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
|
Phase 2 | |
Withdrawn |
NCT01953042 -
Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
|
N/A | |
Completed |
NCT02655926 -
Deep Brain Stimulation for Severe Obsessive Compulsive Disorder
|
N/A | |
Completed |
NCT00742664 -
Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project
|
Phase 1/Phase 2 | |
Completed |
NCT04919785 -
Deep Brain Stimulation in Severe Obsessive-compulsive Disorder
|
N/A | |
Terminated |
NCT00758966 -
Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder
|
Phase 2 | |
Completed |
NCT00523718 -
Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder
|
Phase 2 | |
Completed |
NCT00074815 -
Treatment of Obsessive Compulsive Disorder in Children
|
Phase 3 |