NCT04009928

Deep Brain Stimulation for Treatment Resistant Depression

Deep Brain Stimulation of the Medial Forebrain Bundle and Subcallosal Cingulate for the Treatment of Treatment Resistant Depression

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DEVICE	Active stimulation of the medial forebrain bundle or subcallosal cingulate	Deep brain stimulation of the medial forebrain bundle or subcallosal cingulate
DEVICE	Sham stimulation	Sham stimulation for 2 weeks (Cross-over design)

Timeline

• Start date: 2019-06-15
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2019-07-05
• Last updated: 2023-12-05

Locations

1 site across 1 country: Canada