Deep Brain Stimulation for Treatment Resistant Depression
NCT ID: NCT04009928
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2019-06-15
2024-12-13
Brief Summary
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The medial forebrain bundle (MFB) is a recently described DBS target, with reported rapid onset of antidepressant effects. A recent small randomized trial reported a 100% response rate. The subcallosal cingulate cortex (SCC) is the most commonly used target in DBS for depression.
Herein, the investigators will conduct a sham-controlled randomized trial of DBS to the MFB or SCC for TRD.
Detailed Description
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Following this 6 month open-label optimization phase, patients will be then undergo randomization to receive 2 weeks of stimulation followed by 2 weeks of sham stimulation, or vice versa. These 2 week phases will be separated by a 1 week washout period. Depressive symptoms will be evaluated at the end of each 2 week phase, then patients will resume open-label stimiulation.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Active followed by sham stimulation
2 weeks of active stimulation of the medial forebrain bundle or subcallosal cingulate at the optimized stimulation settings derived during the open-label phase. After 1 week of washout period (with no stimulation), subjects undergo 2 weeks of sham stimulation
Active stimulation of the medial forebrain bundle or subcallosal cingulate
Deep brain stimulation of the medial forebrain bundle or subcallosal cingulate
Sham stimulation
Sham stimulation for 2 weeks (Cross-over design)
Sham followed by active stimulation
2 weeks of sham-stimulation, followed by 2 weeks of active stimulation, separated with 1 week washout period.
This is a crossover study, patients will undergo both arms, the order of which they do is randomized.
Active stimulation of the medial forebrain bundle or subcallosal cingulate
Deep brain stimulation of the medial forebrain bundle or subcallosal cingulate
Sham stimulation
Sham stimulation for 2 weeks (Cross-over design)
Interventions
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Active stimulation of the medial forebrain bundle or subcallosal cingulate
Deep brain stimulation of the medial forebrain bundle or subcallosal cingulate
Sham stimulation
Sham stimulation for 2 weeks (Cross-over design)
Eligibility Criteria
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Inclusion Criteria
2. Patients who are able and willing to give consent and physically and practically able to attend study visits, as determined by both study Psychiatrist and the surgeon.
3. DSM-V diagnosis of major depressive disorder or bipolar II,
4. At least 5-year illness history of the primary disorder and at least 6 months since the onset of the first episode of major depression.
5. A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) when depressed)
6. Medication-refractoriness as determined by an adequate dose and duration of standard psychiatric treatments (including psychotherapy and/or pharmacology) as determined by two psychiatrists associated with the study. Including specifically:
1. Failed to respond or tolerate adequate trial of three or more medications accepted as first line in the treatment of depression
2. Failed to respond or tolerate augmentation with or combination of at least 2 medications known to be first line treatments for depression
3. An adequate trial of cognitive behavioural therapy or other evidence-supported psychotherapy, delivered by a therapist experienced in treating depression
7. A consistent dose of any and all medications in the 30 days prior to study entry.
8. Women of childbearing potential must agree to use a contraception method throughout the study.
Exclusion Criteria
2. Active neurologic disease, such as epilepsy
3. Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
4. Current active suicidal ideation
5. Any contraindication to MRI scanning
6. Presence of significant cognitive impairment
7. Likely to relocate or move out of the country during the study's duration
8. Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
9. Currently pregnant (as determined by history and serum HCG) or lactating; for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
20 Years
80 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Dr. Nir Lipsman
Surgeon-Scientist
Locations
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Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Benjamin Davidson, MD
Role: primary
Sachie Sharma, BSc
Role: backup
Other Identifiers
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277-2018
Identifier Type: -
Identifier Source: org_study_id