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Device
Deep Brain Stimulation for Treatment-Resistant Depression
N/A
Waitlist Available
Research Sponsored by Helen Mayberg, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary psychiatric diagnosis of Major Depressive Disorder (MDD), either single episode or recurrent type, without psychotic features, currently experiencing a Major Depressive Episode (MDE), as diagnosed by Structured Clinical Interview for DSM IV-TR (SCID). Two independent psychiatrists will confirm the diagnosis
Confirmed to have treatment-resistant depression (TRD). Treatment-resistance will be defined as:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation
Awards & highlights
Study Summary
This trial is studying a new way to treat resistant depression by using a device to stimulate a specific region of the brain. The goal is to study changes in electrical signals that are thought to represent how the brain communicates information from one region to another, to see how this relates to the device's parameter settings and patient depressive symptomatology.
Who is the study for?
This trial is for adults aged 25-70 with severe, treatment-resistant Major Depressive Disorder (MDD), who have not responded to multiple treatments including medications and possibly ECT. They must be able to undergo an MRI, live near New York City, and have a caregiver to assist them. Pregnant individuals or those planning pregnancy, people with certain medical conditions or on anticoagulant therapy that can't be stopped are excluded.Check my eligibility
What is being tested?
The study tests the Medtronic Summit RC+S DBS system's ability to alleviate symptoms of severe depression by stimulating a brain region called the subcallosal cingulate. Participants will receive this experimental device implant and their brain activity will be monitored regularly over approximately ten years.See study design
What are the potential side effects?
Potential side effects may include risks associated with neurosurgery and general anesthesia, changes in mood or behavior due to electrical stimulation of the brain, discomfort from regular monitoring procedures like EEGs, and possible interference with other implanted devices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Major Depressive Disorder without psychosis.
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My depression hasn't improved after trying two different treatments.
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I am between 25 and 70 years old.
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I have been depressed for at least 2 years or had more than 3 depressive episodes.
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I have been depressed for at least 2 years or had more than 3 depressive episodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mental Depression
Secondary outcome measures
Mental Depression
Trial Design
1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation (DBS)Experimental Treatment1 Intervention
Open label active Deep Brain Stimulation (DBS)
Find a Location
Who is running the clinical trial?
Emory UniversityOTHER
1,636 Previous Clinical Trials
2,560,563 Total Patients Enrolled
59 Trials studying Depression
9,006 Patients Enrolled for Depression
Helen Mayberg, MDLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Depression
10 Patients Enrolled for Depression
Georgia Institute of TechnologyOTHER
48 Previous Clinical Trials
5,524 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your overall level of functioning is assessed to be 50 or lower.You have a heart device like a pacemaker or defibrillator that could be affected by the study treatment.You have a medical condition that requires MRI scans or diathermy treatment.I need anticoagulant therapy that can't be stopped for surgery.I have been diagnosed with Major Depressive Disorder without psychosis.I cannot or have not benefited from ECT for my condition.I cannot have general anesthesia, neurosurgery, or an MRI.You have a severe impairment in your ability to function in daily life, with a maximum score of 50 or less on a specific assessment tool.My depression hasn't improved after trying two different treatments.I can have an MRI before surgery.I am between 25 and 70 years old.You have had recent thoughts or actions of wanting to harm yourself or end your life.I do not have any major neurological disorders or unstable illnesses.You have other mental health conditions in addition to the one being studied.I have tried at least four different treatments for depression without success.I have been depressed for at least 2 years or had more than 3 depressive episodes.The research team believes I can't properly use or maintain the device.I have been depressed for at least 2 years or had more than 3 depressive episodes.
Research Study Groups:
This trial has the following groups:- Group 1: Deep Brain Stimulation (DBS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04106466 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does your research facility allow for elderly volunteers?
"The target age range for recruitment in this study are individuals who are older than 25 but younger than 70."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What site did they apply to?
Icahn School of Medicine at Mount Sinai, Mount Sinai West
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Looking for help. Call and I can tell you a story you cannot believe.
PatientReceived 1 prior treatment
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