- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01101373
Treatment of Severe Depressive Illness by Targeted Brain Surgery
November 15, 2019 updated by: Trevor Hurwitz, University of British Columbia
Bilateral Anterior Capsulotomy For Intractable Depression
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6T 2A1
- UBC Hospital, 2255 Wesbrook Mall
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All subjects who received BAC for treatment resistant depression between 2000 and 2009
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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1
All subjects who received BAC for treatment resistant depression between 2000 and 2009
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2000
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
April 8, 2010
First Submitted That Met QC Criteria
April 8, 2010
First Posted (Estimate)
April 9, 2010
Study Record Updates
Last Update Posted (Actual)
November 19, 2019
Last Update Submitted That Met QC Criteria
November 15, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H10-00851
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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