Subcallosal cingulate deep brain stimulation for treatment-resistant depression: a multisite, randomised,...

Area of Science:

• Neuroscience
• Psychiatry
• Medical Devices

Background:

• Chronic, unremitting depression poses a significant challenge in treatment.
• Deep brain stimulation (DBS) targeting the subcallosal cingulate white matter is a potential intervention for severe depression.

Purpose of the Study:

• To evaluate the safety and efficacy of subcallosal cingulate DBS for treatment-resistant depression.
• To compare active DBS with sham stimulation in a randomized, controlled trial.

Main Methods:

• A prospective, randomized, sham-controlled trial involving 90 participants with treatment-resistant depression.
• Participants received bilateral subcallosal cingulate DBS, randomized to active or sham stimulation for 6 months, followed by open-label active DBS.
• Primary outcome was response rate (≥40% depression severity reduction) during months 4-6.

Main Results:

• No statistically significant difference in response rates between active (20%) and sham (17%) DBS groups during the double-blind phase.
• Serious adverse events were reported, with some related to the device or surgery.
• The study confirmed safety and feasibility but not statistically significant antidepressant efficacy.

Conclusions:

• Subcallosal cingulate DBS is safe and feasible for treatment-resistant depression.
• The 6-month sham-controlled trial did not demonstrate statistically significant antidepressant efficacy.
• Future research should explore factors like electrode placement and patient selection to enhance DBS efficacy for depression.