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Deep Brain Stimulation
Deep Brain Stimulation Surgery for Treatment Resistant Depression
N/A
Recruiting
Led By Randall Espinoza, MD, MPH
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women (non-pregnant) between ages 21 and 70;
Montreal Cognitive Assessment (MoCA) >25
Must not have
Subjects who have any medical contraindications to undergoing DBS surgery (e.g. infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
Subjects who have a history of hemorrhagic stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is investigating whether a surgical procedure called deep brain stimulation (DBS) is a safe and effective treatment for people with treatment resistant depression.
Who is the study for?
This trial is for adults aged 21-70 with treatment-resistant depression, defined as not responding to at least four different types of antidepressant treatments. Participants must have a current major depressive episode lasting over 24 months or recurrent illness, and severe symptoms measured by specific scales. They should be on stable medication for at least one month before the study and able to attend regular clinic visits for a year.
What is being tested?
The trial tests the Abbott Laboratories Infinity™ deep brain stimulation system targeting the subcallosal cingulate region in the brain using magnetic resonance tractography. This novel approach aims to redefine DBS target based on individual brain anatomy and symptomatic networks rather than structural regions.
What are the potential side effects?
Potential side effects may include risks associated with any surgical procedure such as infection, bleeding, or reactions to anesthesia. Specifics about device-related side effects are not provided but could involve changes in mood or sensation due to stimulation of brain areas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 70 years old and not pregnant.
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My cognitive function is good, with a MoCA score above 25.
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My current major depressive episode has lasted over 24 months or I've had at least 2 episodes, including one longer than 12 months.
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I have tried at least four different depression treatments without success.
Select...
I am between 21 and 70 years old and not pregnant.
Select...
My depression symptoms are severe, scoring 27 or higher on the MADRS.
Select...
I have tried at least four different depression treatments without success.
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My current major depressive episode has lasted 2 years or I've had at least 2 episodes, including one longer than a year.
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My depression symptoms are severe, scoring 27 or higher on the MADRS.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I don't have any health conditions that would make surgery risky for me.
Select...
I have had a bleeding stroke in the past.
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I have a history of seizures.
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I cannot or will not use birth control during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Montgomery and Asberg Depression Rating Scale (MADRS) score.
Secondary study objectives
Change in another related clinical assessment: CGI
Change in another related clinical assessment: CSSRS
Change in another related clinical assessment: HAM-A
+16 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Randomized Discontinuation Period: ON then OFF DBSExperimental Treatment1 Intervention
Subjects randomized to this arm are initially "ON" DBS with optimized stimulation settings for 8 weeks after the open label period and then "OFF" DBS with gradually decreasing amplitude for 8 weeks.
Group II: Randomized Discontinuation Period: OFF then ON DBSExperimental Treatment1 Intervention
Subjects randomized to this arm are initially "OFF" DBS after the open label period then gradually decreased in their optimized setting's amplitude for 8 weeks and then "ON" DBS for 8 weeks.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,562 Previous Clinical Trials
10,262,349 Total Patients Enrolled
Nader PouratianLead Sponsor
3 Previous Clinical Trials
12 Total Patients Enrolled
Randall Espinoza, MD, MPHPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21 and 70 years old and not pregnant.I will keep taking my current antidepressant unless it's unsafe.I don't have any health conditions that would make surgery risky for me.My cognitive function is good, with a MoCA score above 25.I have had a bleeding stroke in the past.You should not have diathermy treatment during the study.You have experienced physical or sexual abuse during your childhood.I will keep taking my current antidepressant unless it's unsafe.Suicide Ideation Questionnaire-Revised (SIQ-R) ≥10
Hamilton Depression Rating Scale-17 item (HDRS17) severity indicates that a person has a major depressive episodeMy current major depressive episode has lasted over 24 months or I've had at least 2 episodes, including one longer than 12 months.I have tried at least four different depression treatments without success.You have a medical condition or neurological issue that the surgeon believes may make you unsuitable for the study.My antidepressant medication has been the same for the last 30 days.I am between 21 and 70 years old and not pregnant.I have a history of seizures.Your symptoms of depression are severe, as measured by a rating scale called HDRS17, with a score of 20 or higher.You have struggled with alcohol or drug addiction in the past 6 months, except for nicotine (smoking).You have recently shown a strong desire to harm yourself, including making a plan or attempting suicide within the past year.I am at a higher risk of bleeding due to my health condition or medications.My depression symptoms are severe, scoring 27 or higher on the MADRS.I cannot or will not use birth control during the study.You have been diagnosed with a severe mental illness like schizophrenia or bipolar disorder in the past.I have tried at least four different depression treatments without success.You have a diagnosed personality disorder.I have been diagnosed with major depression for 10 years or less, starting in adulthood.My current major depressive episode has lasted 2 years or I've had at least 2 episodes, including one longer than a year.My depression symptoms are severe, scoring 27 or higher on the MADRS.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized Discontinuation Period: OFF then ON DBS
- Group 2: Randomized Discontinuation Period: ON then OFF 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.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT03952962 — N/A
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