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OpenTrials
Completed

NCT Number: NCT01849809

Safety and Effectiveness of Gamma Capsulotomy in Intractable OCD

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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: 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.

Exclusion criteria

  • 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).

Treatment and study plan

Gamma Ventral Capsulotomy

Procedure

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Severity Scale

    Time frame: Baseline to 5 years

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Official study title

Safety and Effectiveness of Gamma Capsulotomy in Intractable Obsessive Compulsive Disorder

Important dates

Study start
1993
Primary completion
2011
Study completion
2016
First posted
May 9, 2013
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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