Safety and Effectiveness of Gamma Capsulotomy in Intractable OCD

Safety and Effectiveness of Gamma Capsulotomy in Intractable Obsessive Compulsive Disorder

NCT01849809•Butler Hospital

Summary

A research study of the effectiveness and safety of gamma knife ventral capsulotomy in patients with severe intractable obsessive-compulsive disorder (OCD).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Social and Occupational Functioning Assessment Scale (SOFAS) score of 45 or less.
•2. Persistence of severe symptoms and impairment for five or more years despite: 1. at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with, 2. adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and 3. augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
•3. Age between 18 and 65 years.
•4. Able to understand and comply with instructions.
•5. Able to give fully informed, written consent in the judgment of the Consent Monitor.
•6. Either drug free or on a stable drug regimen for at least 6 weeks.
•7. Good general health.
•8. A family member or significant other is available and willing to communicate with the research team if the patient's clinical status worsens.
•9. The local referring psychiatrist is willing to provide ongoing care.

Exclusion Criteria

•1. Current or past psychotic disorder.
•2. Full-scale IQ below 85.
•3. A clinical history of bipolar mood disorder.
•4. Any current clinically significant neurological disorder or medical illness affecting brain function, other than tic disorders or Tourette syndrome.
•5. Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
•6. Inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia.
•7. Current or unstably remitted substance abuse, dependence, or a positive urine toxicology screen.
•8. Pregnancy and women of childbearing age not using effective contraception.
•9. Unable to adhere to operational and administrative study requirements (in the investigators' judgment).
•10. Clinical history of severe personality disorder.
+1 more criteria

Locations (1)

Butler Hospital

Providence, Rhode Island, United States

Key Dates

Start Date

February 1, 1993

Primary Completion Date

August 1, 2011

Completion Date

August 1, 2016

Last Updated

August 10, 2017

Enrollment

ACTUAL participants

Conditions

Obsessive Compulsive Disorder

Interventions

Gamma Ventral Capsulotomy

PROCEDURE

Precision Analytic Research Methods in OCD

NCT07011901

Obsessive Compulsive Disorder

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RECRUITING

Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation

NCT06763081

Behavioral ActivationMajor Depressive Disorder+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 10, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Safety and Effectiveness of Gamma Capsulotomy in Intractable OCD

Inclusion Criteria

Exclusion Criteria

Precision Analytic Research Methods in OCD

Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation

Brief Cognitive Behaviour Therapy (CBT) for Adolescent OCD in Routine Clinical Practice

Combined Cortical/Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorder

NAC for Treatment-Resistant OCD and Other Related Disorders

Assessments of Obsessive-compulsive Symptoms in Patients With Substances Use Disorder