RecruitingNot Applicable

Safety and Feasibility of DBS for Bipolar Depression

United States5 participantsStarted 2026-08

Plain-language summary

This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar depression without inducing manic switches. The researchers propose to accomplish this by incorporating monitoring of the SCC local field potentials (LFP) for depression tracking and amygdala LFP monitoring for mania prediction while treating Bipolar I patients with SCC DBS Stimulation. This approach could establish a new paradigm for personalized neuromodulation therapy that uses real-time neural monitoring to optimize outcomes while minimizing risks. By incorporating bilateral, dual-site LFP monitoring from both the SCC and amygdala, this research will allow the researchers to assess the therapeutic efficacy of continuous SCC-DBS and develop novel safety biomarkers that could transform the clinical management of DBS therapy in psychiatry. The findings will have immediate implications for clinical practice and will advance the study team's fundamental understanding of the neural circuits underlying mood regulation and dysregulation in bipolar disorder.

Who can participate

Age range

22 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 22-70 years * Ability to provide written informed consent * Primary diagnosis of Bipolar I Disorder confirmed by SCID-5 * Current major depressive episode (MDE) of at least 12 months duration * Stable control of mania for a minimum of 1 year * Agreement to remain on current anti-mania medication regimen * Hamilton Depression Rating Scale-17 (HDRS-17) score ≥20 at screening and baseline * Young Mania Rating Scale (YMRS) score \<12 at screening and baseline * Treatment-resistant depression: failure to respond to at least 4 adequate trials of antidepressant treatment in the current episode. Antidepressant treatments include: Medications (Must include 2 antidepressant medications from different pharmacological classes), Psychotherapy, ECT, repetitive transcranial magnetic stimulation (rTMS), IV ketamine or intra-nasal esketamine. * All patients must be receiving at least one mood stabilizing medication at entry into the trial. Medication regimen must be stable for a minimum of 4 weeks before the baseline visit. * Able to provide informed consent * English-speaking * Deemed suitable surgical candidate by neurosurgical evaluation * Under care of treating psychiatrist willing to collaborate with study team * Able to reside in New York Metropolitan area during first 6 months or willing/able to travel monthly to study site * Provision of at least two emergency contacts age ≥22 residing within reasonable proximity Exclusion Criteria * Current manic or hypom…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hamilton Depression Rating Scale (HDRS)

Timeframe: Baseline and weekly up to 1 year

Trial details

NCT IDNCT07745374

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10

Contact for this trial

Ellie Rapp

646-493-1607 ellie.rapp@mssm.edu

View on ClinicalTrials.gov More Bipolar I Disorder trials