Safety and Effectiveness of Gamma Capsulotomy in Intractable OCD
This trial is active, not recruiting.
|Condition||obsessive compulsive disorder|
|Treatment||gamma ventral capsulotomy|
|Start date||February 1993|
|End date||August 2011|
|Trial size||55 participants|
|Trial identifier||NCT01849809, IRB#2010-001|
A research study of the effectiveness and safety of gamma knife ventral capsulotomy in patients with severe intractable obsessive-compulsive disorder (OCD).
|Intervention model||single group assignment|
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
Male or female participants from 18 years up to 65 years old.
- 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, 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.
- The local referring psychiatrist is willing to provide ongoing care for the duration of the trial.
- Current or past psychotic disorder.
- Full-scale IQ below 85 on the Wechsler Abbreviated Scale of Intelligence (WASI),
- 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).
|Official title||Safety and Effectiveness of Gamma Capsulotomy in Intractable Obsessive Compulsive Disorder|
|Principal investigator||Steven Rasmussen, MD|
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