A Phase 1/2 interventional study of Active stimulation of the medial forebrain bundle or subcallosal cingulate and Sham stimulation in Treatment Resistant Depression, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Sunnybrook Health Sciences Centre · Phase 1/2, Interventional, and Treatment
Treatment resistant depression (TRD) is a major global health concern, and there is a crucial need to develop novel effective treatments.
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.
Eight patients with TRD will be treated with DBS to the MFB. At approximately 2 weeks postoperartively, stimulation will be initiated in all patients. Voltage and contact position will be altered initially, looking for optimal and stabilized responses in depressive symptoms, while trying to minimize any side effects.
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.
472 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 151 are open to participants now.
This study's planned enrollment of 10 is below the median of 51 across 397 interventional studies indexed under Depressive Disorder, Treatment-Resistant.
Browse Depressive Disorder, Treatment-Resistant studies →Sunnybrook Health Sciences Centre is the lead sponsor of 582 studies on the registry; 133 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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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:
Exclusion Criteria:
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
Device: Active stimulation of the medial forebrain bundle or subcallosal cingulate · Device: Sham 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.
Device: Active stimulation of the medial forebrain bundle or subcallosal cingulate · Device: Sham stimulation
Deep brain stimulation of the medial forebrain bundle or subcallosal cingulate
Sham stimulation for 2 weeks (Cross-over design)
Safety: Qualitative report of any adverse events occurring up until 6 months postoperatively
Report of all adverse events (minor and major), including perioperative, followup, and stimulation-related
Time frame: 6 months
Proportion of responders as measured by the Hamilton Depression Score (17-item version) at 6 months
Proportion of patients who have a 40% or greater reduction in their Hamilton Depression Score at 6 months compared to their preoperative baseline score. The Hamilton Depression score is a 17-item score ranging from 0-50, with lower numbers being less severe.
Time frame: 6 months
Mean Hamilton Depression Score (17-item version) at the end of the sham-stimulation compared with at the end of the true-stimulation
At 6 months there is a blinded crossover portion of the study. The Hamilton depressions score will be measured at the end of each of the arms. The score after each arm will be compared. The Hamilton Depression score is a 17-item score ranging from 0-50, with lower numbers being less severe.
Time frame: 6 months
Hamilton Depression score (17-item version) at 12 months
Proportion of patients with 40% or greater decrease in Hamilton Depression Score at 12 months compared to baseline. The Hamilton Depression score is a 17-item score ranging from 0-50, with lower numbers being less severe.
Time frame: 12 months
Montgomery Asberg Depression Depression Rating Scale at 12 months
Proportion of patients with 40% or greater reduction in their Montgomery Asberg Depression Depression Rating Scale at 12 months compared to preoperative baseline. This scale is a 10-item scale with total scores ranging from 0-60, higher numbers being more severe.
Time frame: 12 months
Beck Depression Inventory at 12 months
Mean Beck Depression Inventory at 12 months compared to mean beck depression inventory at baseline. The Beck Depression Inventory is a 21-item scale with total scores ranging from 0-63, with lower numbers being more severe than higher.
Time frame: 12 months
Short Form (36) Health Survey (SF-36) at 12 months
Comparing mean SF-36 score at 12 months to baseline. The Short-form health survey (36) is a 36-item survey, which produces a total score which is normalized to a score of 0-100 (mean 50), with higher scores indicating a higher quality of life.
Time frame: 12 months
Started Jun 2019 (actual). Primary completion is estimated for Dec 2024, 65 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Depressive Disorder, Treatment-Resistant →
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