Radiosurgical Treatment for Obsessive-compulsive Disorder

NCT01004302 | Terminated Phase 2

• 3 other identifiers: CAPPesq 521/02CAPPesq 0968/05CONEP 4891
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 40% of Obsessive-Compulsive Disorder (OCD) patients do not respond to conventional treatments (medications or behavior therapy). For some of them, a neurosurgical treatment can be indicated. Among various surgical techniques, Gamma Knife radiosurgery has the advantage of not requiring the production of burr hole openings in the skull. However, there are no randomized controlled trials of radiosurgical procedures. The investigators' aim is to investigate whether radiosurgery for the treatment of severe and refractory OCD is efficacious and safe, by a double-blind, randomized controlled trial. Forty-eight refractory OCD patients will be randomized into two different groups: the first one will receive standard radiosurgery; the second group will be submitted to a false radiosurgery ("sham operation"). Patients who had been previously submitted to sham surgery will be able to undergo real operations after one year of follow-up, when blinding is broken. For a minimum period of one year, patients will be periodically followed-up in terms of psychiatric changes (including OCD symptoms), global functioning, cognitive/personality changes and neuroimaging findings.

Conditions

Obsessive-compulsive Disorder

Keywords

Obsessive-compulsive disorder; Radiosurgery; Psychosurgery; Treatment outcome; Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

• A reduction of at least 35 % in the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores and an "improved" or "much improved" score on the Clinical Global Impression (CGI) scale

  One year

Study Arms (2)

Sham surgery

SHAM COMPARATOR

Procedure: ventral capsular/ventral striatal gamma capsulotomy

Active radiosurgery

ACTIVE COMPARATOR

Procedure: ventral capsular/ventral striatal gamma capsulotomy

Interventions

ventral capsular/ventral striatal gamma capsulotomy PROCEDURE

Comparison of active radiosurgical with sham radiosurgeries

Also known as: Gamma ventral capsulotomy, Anterior capsulotomy, Gamma Knife radiosurgery

Active radiosurgery; Sham surgery

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A DSM-IV diagnosis of OCD as the main diagnostic entity. If comorbid axis I or II disorders are present, OCD symptoms are the most troublesome among disorders.
• Age range between 18 and 60 years old.
• At least 5 years of OCD symptoms.
• "Yale-Brown Obsessive-Compulsive Scale" (YBOCS) scores greater than 26 (or greater than 13, for isolated obsessions or compulsions).
• Refractoriness criteria fulfilled.
• To be accepted by the "best estimate" method as a treatment refractory patient. It consists in the careful examination of each patient's history by two OCD specialists, so as to confirm refractoriness status.
• Refractoriness criteria:
• At least 3 serotonin reuptake inhibitors have been tried before (selective or not). One of these trials must have included clomipramine. All drugs were used for a minimum of 12 weeks, at the maximum doses or the maximally tolerated doses.
• Previous participation in a cognitive behavior therapy program (exposure and response prevention), for a minimum of 20 hours' time; or participation for some time, without subsequent adherence, due to severe OCD symptoms, and acceptance of the independent review board.
• YBOCS scores reductions after adequate drug therapy and psychotherapy not better than 25 %, or confirmation of no clinical improvements by the mental health professionals who were responsible for the treatments of the patient.
• By the end of adequately conducted pharmacological trials, "Clinical Global Impression" (CGI) scores not better than minimal improvement.
• Previous use of at least two antidepressant augmentation strategies (such as the association of a typical or atypical antipsychotic, another serotonin reuptake inhibitor, a benzodiazepine, lithium carbonate, or buspirone), in adequate doses for a sufficient period of time, without satisfactory responses.

You may not qualify if:

• Less than 18 years or more than 60 years of age.
• Past history of head injury, with posttraumatic amnesia.
• Past or general medical condition, or neurological illness with brain compromise (severe and in active phase)
• History of physiological effects of a substance, as determinant of psychopathological symptoms, or cumulative signs of alcohol or drug abuse in the Central Nervous System (such cortical atrophy), confirmed by a neuroimaging scan.
• Pregnancy or lactation.
• Refusal to participate in radiosurgical procedures.
• Refusal to sign the Patient Information and Consent Form, or refusal to take part in this study.
• History of mental retardation and/or being unable to understand the Patient Information and Consent Form, confirmed by poor performance on neuropsychological tests.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Brown University: collaborator

Study Sites (1)

Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School

São Paulo, São Paulo, 01060970, Brazil

Location

Related Publications (2)

• Batistuzzo MC, Hoexter MQ, Taub A, Gentil AF, Cesar RC, Joaquim MA, D'Alcante CC, McLaughlin NC, Canteras MM, Shavitt RG, Savage CR, Greenberg BD, Noren G, Miguel EC, Lopes AC. Visuospatial Memory Improvement after Gamma Ventral Capsulotomy in Treatment Refractory Obsessive-Compulsive Disorder Patients. Neuropsychopharmacology. 2015 Jul;40(8):1837-45. doi: 10.1038/npp.2015.33. Epub 2015 Feb 3.

  PMID: 25645373 DERIVED

• Lopes AC, Greenberg BD, Canteras MM, Batistuzzo MC, Hoexter MQ, Gentil AF, Pereira CA, Joaquim MA, de Mathis ME, D'Alcante CC, Taub A, de Castro DG, Tokeshi L, Sampaio LA, Leite CC, Shavitt RG, Diniz JB, Busatto G, Noren G, Rasmussen SA, Miguel EC. Gamma ventral capsulotomy for obsessive-compulsive disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Sep;71(9):1066-76. doi: 10.1001/jamapsychiatry.2014.1193.

  PMID: 25054836 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Antonio C Lopes, MD, PhD

  Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 29, 2009
• Study Start: July 1, 2003
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2015
• Last Updated: October 12, 2012

Record last verified: 2012-10

Locations

BR (1)