Major Depressive DisorderNCT01101373
Treatment of Severe Depressive Illness by Targeted Brain Surgery
An observational study of Major Depressive Disorder, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Oct 2000to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects who received BAC for treatment resistant depression between 2000 and 2009
Who may be able to join
- Severe treatment resistant depression of at least 5 years duration
- older than 18 years
Who cannot join
- Comorbid organic mental disorder
- Delusional disorder
- Substance disorder
- Neurological disease
- Cluster B personality disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site
UBC Hospital, 2255 Wesbrook Mall
Vancouver, British Columbia, V6T 2A1
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Keywords
- Limbic surgery, Stereotactic surgery, Major Depressive Disorder: Treatment Refractory
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | All subjects who received BAC for treatment resistant depression between 2000 and 2009 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startOct 2000
- Primary completionNov 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trevor Hurwitz, University of British Columbia
- Investigators
- Christopher Honey, MD, Study director, University of British ColumbiaJudy Allen, MD, Study director, University of British ColumbiaRobert Hewko, MD, Study director, University of British ColumbiaCaroline Gosselin, MD, Study director, University of British ColumbiaNicolas Bogod, MD, Study director, University of British ColumbiaJeff Martzke, MD, Study director, University of British ColumbiaPatricia Taylor, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101373
- Sponsor's protocol ID
- H10-00851
- Status last verified
- Nov 2019
- First submitted
- 8 Apr 2010
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Anterior Capsulotomy For Intractable Depression
- ClinicalTrials.gov ID
- NCT01101373
- Acronym / sponsor ID
- H10-00851
- Conditions
- Major Depressive Disorder
- Keywords
- Limbic surgery, Stereotactic surgery, Major Depressive Disorder: Treatment Refractory
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2000
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –All subjects who received BAC for treatment resistant depression between 2000 and 2009 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who received BAC for treatment resistant depression between 2000 and 2009
Key inclusion criteria (2 listed)
- Severe treatment resistant depression of at least 5 years duration
- older than 18 years
Key exclusion criteria (5 listed)
- Comorbid organic mental disorder
- Delusional disorder
- Substance disorder
- Neurological disease
- Cluster B personality disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Honey, MD study director
University of British Columbia
Judy Allen, MD study director
University of British Columbia
Robert Hewko, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.