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Procedure
DBS for Depression
Phase 1
Recruiting
Led By Albert J Fenoy, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 22 - 70 years
Major Depression Disorder (MDD) diagnosed by Structured Clinical Interview for DSM-V (SCID I/DSM-V)
Must not have
Subject is on anticoagulant medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if deep brain stimulation can help people with treatment-resistant depression. The device is implanted in the brain and sends electrical signals to control mood. Researchers will monitor patients over several years to see if it reduces depression symptoms. Deep brain stimulation (DBS) has a decades-long history in psychiatric neurosurgery and has shown promise for treatment-resistant depression.
Who is the study for?
This trial is for adults aged 22-70 with severe, treatment-resistant depression. They must have tried multiple medications, psychotherapy, and possibly ECT without success. Participants need to be stable on their current meds and willing to be monitored over 5 years. Exclusions include those with psychosis history, unstable living situations, certain medical conditions or contraindications for surgery.
What is being tested?
Researchers are testing a Medtronic SenSight Directional DBS lead device implanted in participants to treat resistant depression. Over five years, the device's effectiveness will be assessed by turning it off at random times without participants' knowledge and comparing their questionnaire scores during these periods.
What are the potential side effects?
Potential side effects may include discomfort from the implantation procedure of the DBS device, headache or infection at the surgical site. There might also be risks related to hardware malfunction or adverse changes in mood or behavior due to stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 70 years old.
Select...
I have been diagnosed with Major Depression Disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication to prevent blood clots.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary study objectives
Clinical Global Impressions (CGI) rated severity
Global Assessment of Functioning (GAF) rated functional impairment
Measuring MADRS during discontinuation cross over weeks
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Discontinuation Phase Group 2Experimental Treatment1 Intervention
Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.
Group II: Discontinuation Phase Group 1Experimental Treatment1 Intervention
Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Major Depressive Disorder (MDD) that involve neuromodulation include Electroconvulsive Therapy (ECT), Repetitive Transcranial Magnetic Stimulation (rTMS), and Transcranial Direct Current Stimulation (tDCS). ECT induces controlled seizures to reset neural circuits, rTMS uses magnetic fields to stimulate specific brain areas, and tDCS applies a low electrical current to modulate brain activity.
These treatments target brain regions involved in mood regulation, such as the prefrontal cortex, to alleviate depressive symptoms. This is particularly important for MDD patients who do not respond to traditional medications, offering alternative pathways to manage and potentially improve their condition.
Find a Location
Who is running the clinical trial?
MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,068 Total Patients Enrolled
Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,114 Total Patients Enrolled
Albert J Fenoy, MDPrincipal InvestigatorNorthwell Health
2 Previous Clinical Trials
122 Total Patients Enrolled