Trial studying safety and effects for Bipolar I Disorder
Official title Safety and Feasibility of DBS for Bipolar Depression
ClinicalTrials.gov ID: NCT07745374
What this study is testing
- What it's testing
- The study wants to see if stimulating a brain area called the subcallosal cingulate can safely improve depression without causing mania, using real‑time brain signal monitoring.
- Who it's for
- Adults with bipolar I disorder who have ongoing depressive episodes that have not responded to standard treatments.
- What's involved
- Participants will have small electrodes surgically placed in two brain regions and will receive continuous electrical stimulation, with regular clinic visits for programming the device and recording brain signals.
- Time commitment
- The trial runs for several months and includes multiple follow‑up visits after the surgery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can 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
- 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.
- 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
What rules you out
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.