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Device
Deep Brain Stimulation for Depression (PReSiDio Trial)
N/A
Recruiting
Led By Andrew Krystal, MD, MS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing and able to undergo invasive brain recording/stimulation study
Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for Major Depressive Disorder (MDD) without psychosis based on a Structured Clinical Interview for DSM-V (SCID) with current episode ≥ 2 years that is treatment- resistant (4 adequate trials (including ECT), 3 classes of medications, one augmentation strategy, psychotherapy) as measured by the antidepressant treatment history form (ATHF).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at the end of stage 2 (up to 1.5 year duration)
Awards & highlights
PReSiDio Trial Summary
This trial is testing a new way to treat depression by altering brain activity with electrical stimulation. The device is FDA approved for epilepsy, and researchers will be measuring whether it helps reduce depression symptoms.
Who is the study for?
This trial is for adults aged 22-70 with major depression that hasn't improved after trying multiple treatments, including medication, psychotherapy, and ECT. Participants must have a consistent history of depression symptoms and not be planning any changes to their current medication regimen during the study. They should be able to attend research visits, perform at-home protocols, speak English, and provide informed consent.Check my eligibility
What is being tested?
The trial is testing a personalized brain stimulation device called NeuroPace RNS System—approved for epilepsy—to see if it can safely treat major depression. It involves surgically implanting the device to measure brain activity related to depression and using electrical impulses to potentially alter this activity.See study design
What are the potential side effects?
Potential side effects may include discomfort or complications from surgery, infection risk from implanted hardware, possible headaches or scalp pain post-surgery, and unknown risks associated with altering brain activity through electrical stimulation.
PReSiDio Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to participate in a study involving brain recording/stimulation.
Select...
I have been diagnosed with long-term depression without psychosis and treatments haven't worked.
Select...
I am between 22 and 70 years old.
Select...
I have been diagnosed with long-term depression without psychosis and treatments haven't worked.
Select...
I stopped ECT because it didn't work or the side effects were too bad.
PReSiDio Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at the end of stage 2 (up to 1.5 year duration)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at the end of stage 2 (up to 1.5 year duration)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in MADRS score
Secondary outcome measures
change in Montgomery Asberg Depression Rating Scale (MADRS) score after 1 year
difference in Hamilton Depression Rating Scale (HAMD-17) score
difference in Hamilton Depression Rating Scale (HAMD-17) score after 1 year
+2 moreOther outcome measures
Achievement of Long-Term Symptom Control
Biomarker identification in Stage 1
Non-inferiority of closed loop vs open-loop intermittent stimulation therapy and sham stimulation
+5 morePReSiDio Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Arm 1: Intervention (stimulation ON)Experimental Treatment1 Intervention
This is a crossover trial. Each patient will receive 6 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and Stimulation ON Active Control (sham biomarker) (arm 3) in random order. After 6 months of intervening therapy, this 3-period crossover study will be repeated.
Group II: Arm 3: Active Control (stimulation ON triggered by sham biomarker)Active Control1 Intervention
This is a crossover trial. Each patient will receive 6 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and stimulation ON Active Control (sham biomarker) (arm 3) in random order. After 6 months of intervening therapy, this 3-period crossover study will be repeated.
Group III: Arm 2: Sham Control (stimulation OFF)Placebo Group1 Intervention
This is a crossover trial. Each patient will receive 6 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and Stimulation ON Active Control (sham biomarker) (arm 3) in random order. After 6 months of intervening therapy, this 3-period crossover study will be repeated.
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,515 Previous Clinical Trials
15,244,455 Total Patients Enrolled
71 Trials studying Depression
28,268 Patients Enrolled for Depression
Andrew KrystalLead Sponsor
1 Previous Clinical Trials
Andrew Krystal, MD, MSPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
79 Total Patients Enrolled
2 Trials studying Depression
65 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to participate in a study involving brain recording/stimulation.I have a history of seizures.I am between 22 and 70 years old.I have been diagnosed with long-term depression without psychosis and treatments haven't worked.I cannot stop taking blood thinners for surgery.I have been diagnosed with long-term depression without psychosis and treatments haven't worked.My mental health medication has been stable for the last 4 weeks.I am unable to understand and give consent for treatment.I stopped ECT because it didn't work or the side effects were too bad.I live alone and do not have anyone to care for me after leaving the hospital.I have been diagnosed with a specific mental health condition other than depression or generalized anxiety.I have serious health issues that could make surgery risky.I have been diagnosed with fibromyalgia or chronic fatigue syndrome.I have had brain surgery or a device implanted for brain stimulation.I might need electroconvulsive therapy during the study.My depression rating changes by at least 2 points when tested multiple times over 3 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3: Active Control (stimulation ON triggered by sham biomarker)
- Group 2: Arm 1: Intervention (stimulation ON)
- Group 3: Arm 2: Sham Control (stimulation OFF)
Awards:
This trial has 0 awards, including: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: NCT04004169 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study require participants to be over 25 years old?
"This particular trial is only enrolling patients aged 22-70. Out of the 206 trials that exist for people under 18 and 1003 trials for those over 65, this is the one you want to be a part of!"
Answered by AI
Are new enrollees still being accepted into the research?
"The online clinical trials database reports that this study is still recruiting patients. This trial was originally posted on July 18th, 2019 and updated as recently as January 13th, 2021."
Answered by AI
How can I sign up to be a part of this clinical research?
"The ideal candidate for this study suffers from melancholia and is between 22 and 70 years old. So far, the research team has recruited 12 patients."
Answered by AI
How many people are included in this investigation?
"Yes, according to the information on clinicaltrials.gov, this study is still looking for patients. The trial was first posted on 7/18/2019 and was last updated on 1/13/2021. They are hoping to enroll 12 patients at 1 location."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
New York
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
Sick of taking tons of medication with little effectiness. Looking for help.
PatientReceived no prior treatments
I tried Prozac, Lamictal, oral ketamine, TMS, a psychotherapy, and mindfulness meditation. These treatments provided limited relief. I hope for a new treatment that will be more effective.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
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