NCT01849809

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 1993

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1993

Completed
18.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

18.5 years

First QC Date

February 12, 2013

Last Update Submit

August 9, 2017

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • Yale-Brown Obsessive Compulsive Severity Scale

    Baseline to 5 years

Study Arms (1)

Gamma Ventral Capsulotomy

EXPERIMENTAL
Procedure: Gamma Ventral Capsulotomy

Interventions

Gamma Ventral CapsulotomyPROCEDURE
Gamma Ventral Capsulotomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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: 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.
  • 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.

You may not qualify if:

  • Current or past psychotic disorder.
  • Full-scale IQ below 85.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • Rasmussen SA, Noren G, Greenberg BD, Marsland R, McLaughlin NC, Malloy PJ, Salloway SP, Strong DR, Eisen JL, Jenike MA, Rauch SL, Baer L, Lindquist C. Gamma Ventral Capsulotomy in Intractable Obsessive-Compulsive Disorder. Biol Psychiatry. 2018 Sep 1;84(5):355-364. doi: 10.1016/j.biopsych.2017.11.034. Epub 2017 Dec 15.

    PMID: 29361268DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Steven Rasmussen, MD

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Butler Hospital

Study Record Dates

First Submitted

February 12, 2013

First Posted

May 9, 2013

Study Start

February 1, 1993

Primary Completion

August 1, 2011

Study Completion

August 1, 2016

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations

US(1)