Deep Brain Stimulation of the Medial Forebrain Bundle and Subcallosal Cingulate for the Treatment of Treatment Resistant Depression
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.
• Men and women ≥20 and ≤80 years of age.
• 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.
• DSM-V diagnosis of major depressive disorder or bipolar II,
• 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.
• A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) when depressed)
• 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:
‣ Failed to respond or tolerate adequate trial of three or more medications accepted as first line in the treatment of depression
⁃ Failed to respond or tolerate augmentation with or combination of at least 2 medications known to be first line treatments for depression
⁃ An adequate trial of cognitive behavioural therapy or other evidence-supported psychotherapy, delivered by a therapist experienced in treating depression
• A consistent dose of any and all medications in the 30 days prior to study entry.
• Women of childbearing potential must agree to use a contraception method throughout the study.