Recruiting

SCC DBSSafety and Feasibility of DBS for Bipolar Depression

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07745374

Conditions

Bipolar I Disorder

Bipolar Depression

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

Interventions

Medtronic Percept PC DBS system

Study Details

Brief 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.

Conditions

Bipolar I Disorder

Bipolar Depression

Study ID

NCT07745374

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

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 hypomanic episode (YMRS ≥12)
Rapid cycling pattern (≥4 mood episodes in the past 12 months)
Active suicidal ideation with intent or plan
Suicide attempt within six months prior to baseline
Current psychotic symptoms
Primary diagnosis of schizophrenia, schizoaffective disorder, or other psychotic disorder
History (current and/or lifetime) of one or more schizophrenia-spectrum or other psychotic disorders including: schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, and major depressive disorder with psychosis (unipolar or bipolar), and/or psychotic depression (unipolar or bipolar) (does not include psychosis occurring in the context of a manic episode of a subject with bipolar disorder)
Substance use disorder (moderate or severe) within 6 months
Presence of any type of dementia / Major Neurocognitive Disorder / significant cognitive impairment interfering with study participation
Subject has had a prior VNS Therapy or deep brain stimulation (DBS) implant
Subject has a diagnosis of Substance Use Disorder as defined by the DSM-V without sustained remission (12 months or longer)
History of borderline or severe personality disorder, as determined by clinical judgment, which would significantly interfere with a subject's participation in the study
Active primary diagnosis of one or more of the following disorders: obsessive-compulsive disorder, eating disorder, or post-traumatic stress disorder
Cognitive or psychiatric deficit (e.g., amnesia, delirium) that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments
Current or lifetime history of psychotic features in any major depressive episode (MDE)
Treatment with another investigational device or investigational drugs
Contraindications to MRI (metallic implants, claustrophobia unmanageable with anxiolytics)
Contraindications to general anesthesia or neurosurgery
Significant structural brain abnormalities precluding safe electrode placement
Active infection or immunocompromised state
Active unstable medial condition (diabetes, heart disease, hypertension, cancer, endocrine)
BMI >35; and/or CRP >3
Coagulopathy or anticoagulation that cannot be safely interrupted
Pregnancy or planning pregnancy during study period
Women of childbearing potential unwilling to use effective contraception
Prisoners or institutionalized individuals
Decisionally impaired individuals (unless previously consented when capacitated)
Special status patients (employees, VIPs, celebrities, public figures) unless consented before special status known

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with Bipolar disorder

Participants with BPD will be treated with open label active bilateral Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) with ongoing local field potential monitoring from the SCC and amygdala.

Interventions

Medtronic Percept PC DBS system

Open label active Deep Brain Stimulation (DBS) with continuous monitoring of local field potentials (LFP) from the SCC and amygdala.

Primary outcome measure

Hamilton Depression Rating Scale (HDRS) [ Time Frame: Baseline and weekly up to 1 year ]

Central Contacts and Locations

Central contacts

Ellie Rapp

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

Avantika Vardhan

avantika.vardhan@mssm.edu

Locations

Center for Advanced Circuit Therapeutics, Clinical Neurosciences Center, Mount Sinai West

Recruiting

New York, New York, United States, 10019

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

deep brain stimulation
safety
subcallosal cingulate
local field potentials
Bipolar 1 depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-08-04.