← Back to Search

Device

Deep Brain Stimulation for Depression

N/A
Waitlist Available
Led By Jair C Soares, MD, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recurrent (equal or >4 episodes) or chronic (episode duration equal or higher >2 years) course AND a minimum of 5 years since the onset of the first depressive episode
Major Depression Disorder (MDD) diagnosed by Structured Clinical Interview for DSM-IV (SCID I/DSM-IV), judged to be of disabling severity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, and 24 months
Awards & highlights

Study Summary

This trial will study the effects of DBS on the medial forebrain bundle to treat refractory depression in 20 patients.

Who is the study for?
This trial is for adults aged 22-70 with severe, treatment-resistant depression (TRD) who have tried multiple medications, psychotherapy, and possibly ECT without success. Participants must be in generally good health and not currently abusing substances. Pregnant women or those at risk of pregnancy without effective contraception are excluded.Check my eligibility
What is being tested?
The study tests Deep Brain Stimulation (DBS) using the Percept™ PC system by Medtronic Neurological to target the medial forebrain bundle in patients with TRD. The goal is to see if DBS can reduce depressive symptoms in those who haven't responded to other treatments.See study design
What are the potential side effects?
Potential side effects of DBS may include headache, seizure, confusion, hardware complications like lead displacement or infection, mood changes such as mania or apathy, and impaired coordination or speech.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My depression has recurred 4+ times or lasted 2+ years, starting over 5 years ago.
Select...
I have been diagnosed with severe depression.
Select...
I am between 22 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, and 24 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
Changes in patients MADRS scores
Secondary outcome measures
Accuracy of Electrode placement
Assess maintenance of treatment response (or remission) associated with chronic DBS
Decrease in Neurocognitive scores on CSTC
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain StimulationExperimental Treatment1 Intervention
Device implantation (Deep Brain Stimulation Model 3387 Model 3389)

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
605 Previous Clinical Trials
828,295 Total Patients Enrolled
8 Trials studying Depression
70 Patients Enrolled for Depression
The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
321,105 Total Patients Enrolled
17 Trials studying Depression
3,050 Patients Enrolled for Depression
Jair C Soares, MD, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Depression
30 Patients Enrolled for Depression

Media Library

Deep Brain Stimulation Model 3387 Model 3389 (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02046330 — N/A
Depression Research Study Groups: Deep Brain Stimulation
Depression Clinical Trial 2023: Deep Brain Stimulation Model 3387 Model 3389 Highlights & Side Effects. Trial Name: NCT02046330 — N/A
Deep Brain Stimulation Model 3387 Model 3389 (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02046330 — N/A

Frequently Asked Questions

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

Is it possible to become a participant in this experiment?

"This clinical trial seeks to enrol sixteen individuals aged between 22 and 70 who are suffering from depression. To be eligible, participants must possess a 24-item Hamilton Depression Rating Scale score of 21 or higher on the first 17 items, Global Assessment of Function rating at 45 or lower, recurrent (4 episodes+) or chronic (>2 years) course with minimum 5 years since initial episode onset as well as major impairment in functioning/potential severe medical outcomes. Furthermore, they must have attempted 6+ weeks of antidepressant treatment across three classes before entry into study alongside 4+weeks augmentation/combination using lithium, T3 etc., unsuccessful ECT"

Answered by AI

Is this research looking for participants of a certain age range?

"As per the requirements stipulated for inclusion in this medical trial, participants must be between 22 and 70 years old."

Answered by AI

Could you tell me if this study is actively enrolling participants?

"The information on clinicaltrials.gov indicates that this medical trial is no longer enrolling patients, with the original posting dating back to November 1st 2013 and the last update occurring on September 6th 2022. Nonetheless, there are still 1305 other studies actively recruiting volunteers at present."

Answered by AI

Who else is applying?

What state do they live in?
California
New York
Texas
How old are they?
18 - 65
What site did they apply to?
UT Center of Excellence on Mood Disorders
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I've tried other methods that didn't work.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. UT Center of Excellence on Mood Disorders: < 48 hours
Average response time
  • < 2 Days
~1 spots leftby Mar 2025