Deep Brain Stimulation for Treatment-Resistant Depression
This study is testing a treatment called Deep Brain Stimulation (DBS) using the Infinity™ system for adults with severe depression that hasn't improved with other treatments (treatment-resistant depression). DBS involves placing small devices in the brain to deliver electrical pulses. Researchers want to see if active DBS is effective and safe compared to a sham-stimulation (inactive device). You might be able to join if you are 22-70 years old, have non-psychotic unipolar Major Depressive Disorder, and have tried at least four different antidepressant treatments without success. The study will measure success by looking at changes in your depression symptoms after 12 months.
- Study design
- This is a randomized, double-blind study with 100 planned participants. Half will receive active DBS, and the other half will receive sham-stimulation for 12 months.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months to measure changes in depression symptoms and response rates.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
At a glance
Conditions
Where it's being run
25 sites across 17 statesStudy leadership
- Brian Kopell, MD · PRINCIPAL_INVESTIGATOR · MOUNT SINAI HOSPITAL
- Mark George, MD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
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What this trial measures
- Change in MADRS total score12 months
The MADRS absolute change is measured as score change from baseline to the endpoint evaluation period. The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
- CGI-I response rate12 months
The CGI-I response is defined as a rating of "very much improved" or "much improved." The Clinical Global Impression of Severity and Improvement (CGI-I) is a clinician-rated tool used to measure the global impression of a treatment response in a patient's by comparing their baseline condition (i.e., before DBS system implant) with their current state.