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Treatment of Severe Depressive Illness by Targeted Brain Surgery

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01101373
First received: April 8, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

This study will report on the outcome of a clinical program, operational since 1998, that has used surgery targeting an emotional pathway in the brain in the treatment of severe depressive illness that has failed to respond to all other available interventions. Benefit from surgery was anticipated on the basis that the lesion (bilateral anterior capsulotomy) is a well established surgical target for treating severe treatment resistant depression.


Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Bilateral Anterior Capsulotomy For Intractable Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Study Start Date: October 2000
Study Completion Date: April 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
All subjects who received BAC for treatment resistant depression between 2000 and 2009

Detailed Description:

Since 1998 bilateral anterior capsulotomy (BAC) has been available to patients in British Columbia Canada who have treatment refractory severe depressive illness. This study will report on the outcome of patients who have received this intervention. BAC is achieved by stereotactic radiofrequency lesioning. To date 8 patients have received BAC. For all patients there is follow-up data of at least 24 months. The purpose of this retrospective study is to report on the surgical protocol and to demonstrate the efficacy and safety of BAC in severe depression.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All subjects who received BAC for treatment resistant depression between 2000 and 2009

Criteria

Inclusion Criteria:

  • Severe treatment resistant depression of at least 5 years duration
  • older than 18 years

Exclusion Criteria:

  • Comorbid organic mental disorder
  • Delusional disorder
  • Substance disorder
  • Neurological disease
  • Cluster B personality disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101373

Locations
Canada, British Columbia
UBC Hospital, 2255 Wesbrook Mall
Vancouver, British Columbia, Canada, V6T 2A1
Sponsors and Collaborators
University of British Columbia
Investigators
Study Director: Christopher Honey, MD University of British Columbia
Study Director: Judy Allen, MD University of British Columbia
Study Director: Robert Hewko, MD University of British Columbia
Study Director: Caroline Gosselin, MD University of British Columbia
Study Director: Nicolas Bogod, MD University of British Columbia
Study Director: Jeff Martzke, MD University of British Columbia
Study Director: Patricia Taylor University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Trevor Hurwitz, University of British Columbia - Vancouver Coastal Health Research Institute
ClinicalTrials.gov Identifier: NCT01101373     History of Changes
Other Study ID Numbers: H10-00851
Study First Received: April 8, 2010
Last Updated: April 8, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Limbic surgery
Stereotactic surgery
Major Depressive Disorder: Treatment Refractory

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013