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Deep Brain Stimulation for Depression
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Directional Deep Brain Stimulation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Does this investigation include elderly participants?
"For this medical trial, individuals between the ages of 22 and 70 are eligible to apply. Notably, there are 193 trials suited for minors below 18 years old, as well as 968 studies intended for patients over 65."
What are the eligibility criteria for participation in this trial?
"To qualify for this research, prospective participants must be between 22 and 70 years old, as well as have been diagnosed with depression. The study requires 12 individuals in total."
What is the estimated size of the participant pool for this research endeavor?
"Affirmative. Clinicaltrials.gov shows that this clinical trial was first posted on August 20, 2019 and recently updated on November 24th 2021. At present they are recruiting 12 patients from two medical centres."
Is this research project currently enrolling participants?
"As per clinicaltrials.gov, this research endeavour is actively recruiting volunteers; with the original posting taking place on August 20th 2019 and its most recent revision occurring November 24th 2021."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- University of Texas Southwestern: < 24 hours
- Baylor College of Medicine: < 48 hours
Average response time
- < 2 Days
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