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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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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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I will keep taking my current antidepressant unless it's unsafe.
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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.
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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 antidepressant medication has been the same for the last 30 days.
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I am between 21 and 70 years old and not pregnant.
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My depression symptoms are severe, scoring 27 or higher on the MADRS.
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I have tried at least four different depression treatments without success.
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I have been diagnosed with major depression for 10 years or less, starting in adulthood.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Montgomery and Asberg Depression Rating Scale (MADRS) score.
Secondary outcome measures
Change in another related clinical assessment: CGI
Change in another related clinical assessment: CSSRS
Change in another related clinical assessment: HAM-A
+16 more

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
1,525 Previous Clinical Trials
10,279,822 Total Patients Enrolled
Nader PouratianLead Sponsor
1 Previous Clinical Trials
Randall Espinoza, MD, MPHPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

Abbott Laboratories Infinity™ implantable deep brain stimulation system (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03952962 — N/A
Major Depressive Disorder Research Study Groups: Randomized Discontinuation Period: OFF then ON DBS, Randomized Discontinuation Period: ON then OFF DBS
Major Depressive Disorder Clinical Trial 2023: Abbott Laboratories Infinity™ implantable deep brain stimulation system Highlights & Side Effects. Trial Name: NCT03952962 — N/A
Abbott Laboratories Infinity™ implantable deep brain stimulation system (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03952962 — N/A
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT03952962 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this clinical trial?

"This clinical study seeks to enroll 12 individuals, aged 21-70 years old, who suffer from persistent or recurrent depression and have been resistant to at least four prior treatment attempts. Furthermore, all applicants need a Hamilton Depression Rating Scale-17 item (HDRS17) score of 20 or more and Montgomery Asberg Rating Scale (MADRS) score of 27 or more one week pre-operatively. These participants must remain on stable antidepressant medication throughout the trial unless there are safety concerns."

Answered by AI

Are individuals younger than 25 being considered for participation in the trial?

"This particular medical trial is looking for applicants aged between 21 to 70. However, there are 191 trials specifically targeting younger patients and 966 that prioritize those over the age of 65."

Answered by AI

Is this experiment currently seeking participants?

"According to the clinicaltrials.gov platform, this medical trial is actively searching for volunteers; it was first introduced on October 28th 2022 and has been recently updated on October 31st of the same year."

Answered by AI

What is the scope of this clinical research in terms of participants?

"Affirmative. According to clinicaltrials.gov, the trial was first made available on October 28th 2022 and has been actively recruiting since then. 12 participants are sought from 2 separate medical centres."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
How old are they?
65+
What site did they apply to?
University of California, Los Angeles
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

treatment and money from study. I been on all kinds if antidepression over 30 nothing seens to help.
PatientReceived 2+ prior treatments
My next step is ECT for my bipolar depression. Looking for an alternative.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. University of California, Los Angeles: < 24 hours
  2. UT Southwestern Medical Center: < 48 hours
~6 spots leftby Jul 2025