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Device
Deep Brain Stimulation for Depression
N/A
Recruiting
Led By Sameer A Sheth, MD, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DSM-5 diagnosis of major depression disorder (MDD) as the primary diagnosis
Previous trial of Electroconvulsive Therapy (ECT)
Must not have
Neurological/Medical condition that makes the patient a poor surgical candidate
Medical contraindication to surgery such as infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 54 to 60 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new brain stimulator to see if it can help people with treatment-resistant depression by targeting different areas of the brain.
Who is the study for?
This trial is for adults aged 22-70 with major depressive disorder (MDD) who haven't improved after trying at least four different depression treatments and ECT or psychotherapy. They must have a stable medication regimen, normal brain MRI, no bipolar or certain personality disorders, no recent substance abuse, and not be pregnant.
What is being tested?
The study tests a new type of Deep Brain Stimulation (DBS) that directs electrical currents to specific brain networks linked to depression. It aims to show this method can change behavior by targeting these networks and is safe for long-term use in reducing symptoms of severe depression.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, headache, nausea, changes in mood or sleep patterns. There's also a risk of bleeding or infection from surgery and possible device-related complications like battery failure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with major depression as my main health issue.
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I have undergone Electroconvulsive Therapy (ECT) before.
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I've had at least 6 weeks of psychotherapy without feeling better.
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My depression symptoms are severe, scoring 27 or higher on the MADRS.
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I am between 22 and 70 years old and not pregnant.
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My recent brain MRI does not show anything that would stop me from joining.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a health condition that makes surgery risky for me.
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I cannot have surgery due to a medical condition like an infection.
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I have bipolar disorder with rapid mood changes and was hospitalized for a manic episode in the last 5 years.
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I have high blood pressure and heart disease.
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I have a history of seizures or am at high risk for seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 54 to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~54 to 60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in depressive symptoms
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Directional Deep Brain StimulationExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,483 Total Patients Enrolled
29 Trials studying Depression
7,069 Patients Enrolled for Depression
University of TexasOTHER
189 Previous Clinical Trials
143,027 Total Patients Enrolled
11 Trials studying Depression
1,458 Patients Enrolled for Depression
Sameer A Sheth, MD, PhDPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My depression score has been 20 or higher twice in the last month.You must have a normal brain MRI within 3 months of enrollment.I have a long-term illness lasting over 24 months or have had at least 2 episodes of it.I have a health condition that makes surgery risky for me.I cannot have surgery due to a medical condition like an infection.I have been diagnosed with major depression as my main health issue.My recent brain MRI, taken within the last 3 months, shows no abnormalities.My chronic illness has lasted 2 years or more, or I've had it at least twice in my life.I've had at least 6 weeks of therapy but didn't get better.I have undergone Electroconvulsive Therapy (ECT) before.I've had at least 6 weeks of psychotherapy without feeling better.I have tried at least four different depression treatments without success.I have tried ECT before and it didn't work, I couldn't tolerate it, or I refused it.I have bipolar disorder with rapid mood changes and was hospitalized for a manic episode in the last 5 years.I have high blood pressure and heart disease.My depression has not improved despite treatment.I've had ECT before but it only helped a little or for a short time.You have a score of 20 or higher on the Hamilton Depression Rating Scale-17 item (HDRS17).My depression symptoms are severe, scoring 27 or higher on the MADRS.I have tried at least four depression treatments from two categories without success.I have a history of seizures or am at high risk for seizures.My depression symptoms are severe, scoring 27 or higher on the MADRS.I regularly use blood thinners that can't be safely stopped.You have been diagnosed with major depression disorder (MDD) and are currently experiencing a major depressive episode.I am between 22 and 70 years old and not pregnant.My recent brain MRI does not show anything that would stop me from joining.My antidepressant medication has not changed in the last month.I am between 22 and 70 years old and not pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Directional Deep Brain Stimulation
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: NCT03437928 — N/A
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