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Safety and Effectiveness of Gamma Capsulotomy in Intractable OCD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01849809
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Steven Rasmussen, Butler Hospital

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

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Procedure: Gamma Ventral Capsulotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Gamma Capsulotomy in Intractable Obsessive Compulsive Disorder
Study Start Date : February 1993
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gamma Ventral Capsulotomy Procedure: Gamma Ventral Capsulotomy



Primary Outcome Measures :
  1. Yale-Brown Obsessive Compulsive Severity Scale [ Time Frame: Baseline to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  11. Imminent risk of suicide (in the investigators' judgment).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849809


Locations
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United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Investigators
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Principal Investigator: Steven Rasmussen, MD Butler Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Steven Rasmussen, Medical Director, Butler Hospital, Butler Hospital
ClinicalTrials.gov Identifier: NCT01849809     History of Changes
Other Study ID Numbers: IRB#2010-001
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders