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Clinical Trials/NCT01849809
NCT01849809CompletedNot Applicable

Safety and Effectiveness of Gamma Capsulotomy in Intractable Obsessive Compulsive Disorder

Butler Hospital2 sites in 1 country57 target enrollmentStarted: February 1993Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
57
Locations
2
Primary Endpoint
Yale-Brown Obsessive Compulsive Severity Scale
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

Open Label

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.
  • •Persistence of severe symptoms and impairment for five or more years despite:
  • •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,
  • •adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and
  • •augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
  • •Age between 18 and 65 years.
  • •Able to understand and comply with instructions.
  • •Able to give fully informed, written consent in the judgment of the Consent Monitor.
  • •Either drug free or on a stable drug regimen for at least 6 weeks.
  • •Good general health.
  • •A family member or significant other is available and willing to communicate with the research team if the patient's clinical status worsens.
  • •The local referring psychiatrist is willing to provide ongoing care.

Exclusion Criteria

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

Arms & Interventions

Gamma Ventral Capsulotomy

Experimental

Intervention: Gamma Ventral Capsulotomy (Procedure)

Outcomes

Primary Outcomes

Yale-Brown Obsessive Compulsive Severity Scale

Time Frame: Baseline to 5 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Steven Rasmussen

Medical Director, Butler Hospital

Butler Hospital

Study Sites (2)

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