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Procedure
DBS for Treatment-Resistant Depression
N/A
Waitlist Available
Led By Wayne K Goodman, MD
Research Sponsored by Wayne Goodman MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Treatment resistance defined by failure to respond to a minimum of three adequate depression treatments from at least two different treatment categories
Other medical conditions must be stable for at least 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, month 12 and 18 months
Awards & highlights
Study Summary
This trialwill study if a brain stimulation technique (DBS) can help 6 people with depression that hasn't been helped by other treatments. Primary outcome measure will be their depression levels 6 months after the stimulation.
Who is the study for?
Adults aged 21-70 with treatment-resistant major depression, having chronic or recurrent episodes and not responding to multiple treatments. Participants must have a stable mental state, no substance abuse in the last 6 months (except prescribed/nicotine/cannabis), no neurological diseases like Parkinson's, seizure disorders, or recent participation in other trials. Pregnant women and those planning pregnancy are excluded.Check my eligibility
What is being tested?
The trial is testing deep brain stimulation (DBS) of the lateral habenula for safety and effectiveness in treating major depression that hasn't improved with standard treatments. Six adults at Baylor College will undergo DBS implant surgery and be monitored using the Hamilton Depression Rating Scale over six months.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, headache, infection risk from surgery, mood swings or changes due to stimulation adjustments, possible cognitive effects like memory issues but specifics will depend on individual responses to DBS.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My depression hasn't improved after trying three different treatments.
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My other health conditions have been stable for at least a year.
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I am between 21 and 70 years old and not pregnant.
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I have been diagnosed with major depression that started before I was 45.
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I have a long-term illness lasting over 24 months or have had it come back 4 times.
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My depression is severe, scoring 21 or higher twice in the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 6, month 12 and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6, month 12 and 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HDRS^17 score from baseline to 6 months after the commencement of stimulation
Secondary outcome measures
Clinical Global Impression of Improvement (CGI-I)
Clinical Global Impression of Severity (CGI-S)
Columbia Suicide Severity Rating Scale (C-SSRS)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Randomized, staggered withdrawal phaseExperimental Treatment1 Intervention
For responders only: double blind discontinuation will be attempted on either the 12 or 13 month visit. Stimulation intensity will be decreased by 50% and then completely discontinued two weeks later. Subjects will be seen biweekly until 15 months post activation or escape criteria are met. These escape criteria include relapse at 2 visits, hospitalization, active suicidal ideation, or withdrawing consent. If any of these criteria are met, the blind will be broken and open treatment will be resumed.
Group II: Activa Tremor Control Sys (DBS Implant)Experimental Treatment1 Intervention
all subjects will receive bilateral surgical implantation of DBS system. Those who respond at 12 months will enter a randomized, staggered withdrawal phase.
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Who is running the clinical trial?
Wayne Goodman MDLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
Wayne K Goodman, MDPrincipal InvestigatorBaylor College of Medicine
1 Previous Clinical Trials
3 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still signing up to participate in this experiment?
"The trial's post on clinicaltrials.gov states that it is not presently searching for applicants, though the study was initially posted February 1st 2013 and last updated October 27th 2022. However, there are 1299 other open medical trials recruiting participants as of now."
Answered by AI
Might I have the opportunity to take part in this experiment?
"Prospective participants must be diagnosed with psychosis, involutional and aged between 21 - 70 years old to qualify for the trial. A total of 6 people are required to join this clinical study."
Answered by AI
Could individuals aged 35 or above be considered for this clinical research endeavor?
"This medical study is looking for participants aged 21 to 70. If a patient does not meet this age criteria, there are 192 relevant studies for individuals younger than 18 and 971 for those older than 65."
Answered by AI
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