Overview

This trial is active, not recruiting.

Condition obsessive compulsive disorder
Treatment gamma ventral capsulotomy
Phase phase 2
Sponsor Butler Hospital
Start date February 1993
End date August 2011
Trial size 55 participants
Trial identifier NCT01849809, IRB#2010-001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
gamma ventral capsulotomy

Primary Outcomes

Measure
Yale-Brown Obsessive Compulsive Severity Scale
time frame: Change from baseline to 1 month, 6 months, 1 year, and then every year up to 30 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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, in contact with the patient every 1-3 days, 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 for the duration of the trial. Exclusion Criteria: 1. Current or past psychotic disorder. 2. Full-scale IQ below 85 on the Wechsler Abbreviated Scale of Intelligence (WASI), 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).

Additional Information

Official title Safety and Effectiveness of Gamma Capsulotomy in Intractable Obsessive Compulsive Disorder
Principal investigator Steven Rasmussen, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Butler Hospital.