Trial of deep brain stimulation for depression begins

Abbott’s newest Infinity deep brain stimulation (DBS) system trial has begun.

On March 5, the Icahn School of Medicine at Mount Sinai announced that the first patient had officially been implanted with Abbott’s DBS system for a multisite, randomized controlled trial of the device’s effects on treatment-resistant depression.

The trial will follow this patient and others for the next three years, according to a Mount Sinai press release. In total, it aims to recruit about 100 participants who haven’t responded to four or more antidepressant treatments, according to clinicaltrials.gov. Half will have their implants turned on and half will not, with the two groups compared after the first year. (After the initial year, the researchers will turn on the DBS system for all participants and monitor their progress for the remaining two years.)

DBS systems like Infinity are used to adjust abnormal activity in areas of the brain that impact Parkinson’s and essential tremor through targeted electrical signals. In 2022, the FDA gave Abbott breakthrough device designation to investigate whether its system can treat treatment-resistant depression this way, too. On Sept. 4, Abbott announced this new trial.

If this is sounding familiar, it’s not just because you’ve been spending too much time watching Severance.

Medical device company St. Jude Medical—which Abbott acquired in 2017—tested Infinity’s precursor (the Libra XP DBS) in a similar trial to treat depression in 2008, but cut the trial short in 2015 after there was no significant difference detected.

Brian Kopell, a principal investigator of the study and director of the Center for Neuromodulation at Mount Sinai Health System in New York, previously told Healthcare Brew that the newest trial has changed up its study design based on new data and used new technology that wasn’t available in 2008.