Bipolar I DisorderNCT07745374
Safety and Feasibility of DBS for Bipolar Depression
A study testing Medtronic Percept PC DBS system in people with Bipolar I Disorder and Bipolar Depression, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Bipolar I Disorder, Bipolar Depression
- What is being tested?
- Medtronic Percept PC DBS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Avantika Vardhan contact
United States1 site, 1 recruiting
- Recruiting
Center for Advanced Circuit Therapeutics, Clinical Neurosciences Center, Mount Sinai West
New York, New York, 10019
About this study
Official title: Deep Brain Stimulation for Bipolar Depression: Assessing the Safety and Use of Intracranial Neurophenotyping of State Switches
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
- Being tested
- Medtronic Percept PC DBS system
- Keywords
- deep brain stimulation, safety, subcallosal cingulate, local field potentials, Bipolar 1 depression
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Percept PC DBS systemDevice
Open label active Deep Brain Stimulation (DBS) with continuous monitoring of local field potentials (LFP) from the SCC and amygdala.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Bipolar disorder | Experimental | 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. Receives: Device: Medtronic Percept PC DBS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS)
The Hamilton Depression Rating Scale (HDRS), is a 17-item questionnaire assessing severity of depression. Scores range from 0-50, with a higher score indicating more severe depression.
Measured: Baseline and weekly up to 1 year
Secondary outcomes (1)
Young Mania Rating Scale (YMRS)
Young Mania Rating Scale (YMRS) is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8. The overall YMRS score ranges from 0-60, with a higher score indicating more severe mania.
Measured: Baseline and weekly up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start21 Sep 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be implanted with two PERCEPT DBS devices and receive open label, active bilateral subcallosal cingulate (SCC) DBS with continuous monitoring of local field potentials (LFP) from the SCC and amygdala. Safety of SCC DBS to reduce depression symptoms without inducing mania will be assessed over 1 year.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Mayberg, MD, Icahn School of Medicine at Mount Sinai
- Investigators
- Helen Mayberg, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745374
- Sponsor's protocol ID
- STUDY-26-00089
- Other IDs
- DG251219
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant demographic and outcome data, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for Bipolar Depression: Assessing the Safety and Use of Intracranial Neurophenotyping of State Switches
- ClinicalTrials.gov ID
- NCT07745374
- Acronym / sponsor ID
- STUDY-26-00089
- Conditions
- Bipolar I Disorder, Bipolar Depression
- Keywords
- deep brain stimulation, safety, subcallosal cingulate, local field potentials, Bipolar 1 depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be implanted with two PERCEPT DBS devices and receive open label, active bilateral subcallosal cingulate (SCC) DBS with continuous monitoring of local field potentials (LFP) from the SCC and amygdala. Safety of SCC DBS to reduce depression symptoms without inducing mania will be assessed over 1 year.
| Arm | Type | Receives |
|---|---|---|
| Participants with Bipolar disorder | Experimental | Device: Medtronic Percept PC DBS systemParticipants 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. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Percept PC DBS systemOpen label active Deep Brain Stimulation (DBS) with continuous monitoring of local field potentials (LFP) from the SCC and amygdala. | Device | Participants with Bipolar disorder |
Primary outcome
Hamilton Depression Rating Scale (HDRS)
Time frame: Baseline and weekly up to 1 year
The Hamilton Depression Rating Scale (HDRS), is a 17-item questionnaire assessing severity of depression. Scores range from 0-50, with a higher score indicating more severe depression.
1 secondary outcome
Young Mania Rating Scale (YMRS)
Time frame: Baseline and weekly up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant demographic and outcome data, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Avantika Vardhan contact
Helen Mayberg, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Percept PC DBS system in people with Bipolar I Disorder and Bipolar Depression, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellie Rapp (646-493-1607, ellie.rapp@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HDRS) (time frame: Baseline and weekly up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.