Actively Recruiting
DBS for Depression
Led by Northwell Health · Updated on 2026-01-20
20
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are: * Is deep brain stimulation effective in treating treatment resistant depression? * Does deep brain stimulation improve overall clinical well-being and functioning? Participants will be implanted with a deep brain stimulation device. They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms. The device will be turned off at certain time points, unbeknown to the participant, to show the efficacy of the device when it is turned on. The device will be ON for 8.5 months and OFF for 3.5 months during the first year. Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression.
CONDITIONS
Official Title
DBS for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Major Depressive Disorder or Bipolar Disorder (I or II) by structured clinical interview
- Aged between 18 and 65 years
- Hamilton Depression Rating Scale score of at least 21 on the first 17 items and/or Montgomery-Asberg Depression Rating Scale score of at least 21
- World Health Organization Disability Assessment Scale 2.0 score of 19 or more
- Recurrent (4 or more episodes) or chronic depression lasting 2 or more years, with at least 5 years since first episode
- History of major impairment in functioning or serious medical outcomes related to depression
- Treatment resistant depression defined by failure to respond to adequate trials of antidepressants from at least 3 classes, augmentation agents, electroconvulsive therapy, and individual psychotherapy
- Able to comply with study requirements and provide written informed consent
- Primary psychiatric diagnosis of major depressive disorder or bipolar disorder
- Stable psychiatric medication regimen for at least 6 weeks before enrollment and throughout first 6 months of study
- Provide information from two verifiable contacts living within 10 miles
- Agree to medical record requests and communication with healthcare providers from past 5 years
- Agree to regular follow-up with a licensed psychiatrist or mental health practitioner
- For ages 18-21: meet psychological maturity scale thresholds and have caretaker oversight
You will not qualify if you...
- History of psychosis or psychotic disorder
- Clinically significant findings on preoperative MRI that increase medical risk or affect study participation
- Previous surgery damaging the DBS target area
- Contraindications to DBS surgery or inability to undergo presurgical MRI (including pacemakers, pregnancy, metal implants, severe claustrophobia)
- Refusal of adequate electroconvulsive therapy trial
- History of intolerance to stimulation
- Substance abuse disorder within 6 months before enrollment
- For women of childbearing potential: positive pregnancy test, unprotected heterosexual activity without effective contraception, or plans to become pregnant during the study
- Active suicidal ideation with intent, recent suicide attempt, or serious suicide risk
- Participation in another drug, device, or biologics trial within 30 days
- Conditions requiring routine MRI or diathermy
- Use of anticoagulant medication
- History of medical, psychiatric, physical, or non-physical conditions that increase risk or affect ability to complete the study
- No fixed home address or unstable living situation
- Significant radiation exposure in past year
- Receiving transcranial magnetic stimulation after DBS implantation
- Mania or manic episodes within 5 years prior to enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zucker Hillside Hospital
Queens, New York, United States, 11004
Actively Recruiting
Research Team
S
Samantha Gonzalez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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