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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
Must not have
Surgical contraindications to undergoing DBS, refusal of an adequate trial of ECT, history of stimulation intolerance, current or unstably remitted substance abuse or dependence, pregnancy, history of severe personality disorder, imminent risk of suicide, participation in another drug, device, or biologics trial within the preceding 30 days, presence of a condition requiring routine MRIs, presence of a condition requiring diathermy, subject is on anticoagulant medication, not able to comply with the operational and administrative requirements of participation in the study, terminal illness associated with expected survival of <12 months
Any current clinically significant neurological disorder, including dementia or medical illness affecting brain function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, and 24 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
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My depression has recurred 4+ times or lasted 2+ years, starting over 5 years ago.
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I have been diagnosed with severe depression.
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I am between 22 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any brain-related health issues like dementia.
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I've had surgery to target a specific area in my brain before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in patients MADRS scores
Secondary study objectives
Accuracy of Electrode placement
Assess maintenance of treatment response (or remission) associated with chronic DBS
Decrease in Neurocognitive scores on CSTC
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
618 Previous Clinical Trials
763,997 Total Patients Enrolled
8 Trials studying Depression
70 Patients Enrolled for Depression
The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
344,569 Total Patients Enrolled
18 Trials studying Depression
3,434 Patients Enrolled for Depression
Joao Quevedo, MD, PhDStudy DirectorThe University of Texas Health Science Center, Houston

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
~3 spots leftby Apr 2027
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