Safety and Effectiveness of Gamma Capsulotomy in Intractable OCD



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:8/11/2017
Start Date:February 1993
End Date:August 2016

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Safety and Effectiveness of Gamma Capsulotomy in Intractable Obsessive Compulsive Disorder

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


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).
We found this trial at
1
site
345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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mi
from
Providence, RI
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