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Procedure

DBS for Treatment-Resistant Depression

N/A

Waitlist Available

Led By Wayne K Goodman, MD

Research Sponsored by Wayne Goodman MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treatment resistance defined by failure to respond to a minimum of three adequate depression treatments from at least two different treatment categories

Other medical conditions must be stable for at least 1 year

Must not have

Any history of seizure disorder or hemorrhagic stroke

Presence of primary or serious (requiring additional treatment) disorders: comorbid obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, bulimia or anorexia, in the last year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 6, month 12 and 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trialwill study if a brain stimulation technique (DBS) can help 6 people with depression that hasn't been helped by other treatments. Primary outcome measure will be their depression levels 6 months after the stimulation.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, headache, infection risk from surgery, mood swings or changes due to stimulation adjustments, possible cognitive effects like memory issues but specifics will depend on individual responses to DBS.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My other health conditions have been stable for at least a year.

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I am between 21 and 70 years old and not pregnant.

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I have been diagnosed with major depression that started before I was 45.

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I have a long-term illness lasting over 24 months or have had it come back 4 times.

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My depression is severe, scoring 21 or higher twice in the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had serious mental health issues like OCD, PTSD, panic, bulimia, or anorexia in the past year.

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I have a neurological condition that affects my daily activities or needs regular medication.

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I do not have any health conditions that prevent me from having surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 6, month 12 and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 6, month 12 and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6, month 12 and 18 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

Change in HDRS^17 score from baseline to 6 months after the commencement of stimulation

Secondary study objectives

Clinical Global Impression of Improvement (CGI-I)

Clinical Global Impression of Severity (CGI-S)

Columbia Suicide Severity Rating Scale (C-SSRS)

+7 more

Awards & 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, 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.

0 / 10Eligibility criteria met