DBS for Treatment-Resistant Depression

Recruiting in Palo Alto (17 mi)

Overseen byWayne K Goodman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wayne Goodman MD

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research study will investigate the safety, tolerability, and benefit of bilateral deep brain stimulation (DBS) to the lateral habenula in subjects with treatment-resistant major depression (TRD) secondary to either nonpsychotic unipolar major depressive disorder (MDD), or bipolar disorder (BD) I. Six adult subjects with TRD will be treated in this single-site study at Baylor College of Medicine; subjects will be chronically symptomatic with significant functional disability, and will have demonstrated resistance to standard somatic and pharmacotherapeutic treatments. The primary outcome measure will be the change in the 17-item Hamilton Depression Rating Scale (HDRS\^17) six months after the commencement of stimulation.

Eligibility Criteria

Adults aged 21-70 with treatment-resistant major depression, having chronic or recurrent episodes and not responding to multiple treatments. Participants must have a stable mental state, no substance abuse in the last 6 months (except prescribed/nicotine/cannabis), no neurological diseases like Parkinson's, seizure disorders, or recent participation in other trials. Pregnant women and those planning pregnancy are excluded.

Inclusion Criteria

My last manic or hypomanic episode was over 2 years ago and I am on a mood stabilizer.

My depression hasn't improved after trying three different treatments.

My antidepressant medication has not changed in the last month.

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Exclusion Criteria

I have a history of seizures or bleeding in the brain.

Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators

Lack of adequate family/friend support as determined by psychological screening and/or interview

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Treatment Details

Interventions

Deep Brain Stimulation (Procedure)

Trial OverviewThe trial is testing deep brain stimulation (DBS) of the lateral habenula for safety and effectiveness in treating major depression that hasn't improved with standard treatments. Six adults at Baylor College will undergo DBS implant surgery and be monitored using the Hamilton Depression Rating Scale over six months.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Randomized, staggered withdrawal phaseExperimental Treatment1 Intervention

For responders only: double blind discontinuation will be attempted on either the 12 or 13 month visit. Stimulation intensity will be decreased by 50% and then completely discontinued two weeks later. Subjects will be seen biweekly until 15 months post activation or escape criteria are met. These escape criteria include relapse at 2 visits, hospitalization, active suicidal ideation, or withdrawing consent. If any of these criteria are met, the blind will be broken and open treatment will be resumed.

Group II: Activa Tremor Control Sys (DBS Implant)Experimental Treatment1 Intervention

all subjects will receive bilateral surgical implantation of DBS system. Those who respond at 12 months will enter a randomized, staggered withdrawal phase.

Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Deep Brain Stimulation for: