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Procedure

Deep Brain Stimulation for Bipolar Disorder (DBS in TRBD Trial)

N/A

Recruiting

Led By Wayne 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

Initial mood episode occurred before the age of 40

Males and females ages 22-64, inclusive

Must not have

Current major and/or unstable medical conditions

Unable to sign the informed consent for any reason

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate the use of Deep Brain Stimulation (DBS) as a potential treatment for severe cases of Treatment-Resistant Bipolar Depression (TRBD). DBS involves surgically

Who is the study for?

This trial is for patients with severe Treatment-Resistant Bipolar Depression (TRBD) who haven't improved with standard treatments. Participants must be willing to undergo surgery to implant a brain stimulation device and commit to a 20-month study period, including multiple evaluations and hospital stays.

What is being tested?

The trial tests Deep Brain Stimulation (DBS) using the Medtronic Percept RC System on TRBD. It involves surgical implantation of electrodes in the brain, followed by regular follow-ups for programming and psychiatric testing over 20 months.

What are the potential side effects?

Risks include bleeding inside the brain (1-2%), infection from procedures (3%), seizures caused by procedures (1.2%), potential lack of effectiveness, loss of confidentiality, and other unknown risks.

Eligibility Criteria

Inclusion Criteria

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

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My first mood disorder episode happened before I turned 40.

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I am between 22 and 64 years old.

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I have been diagnosed with Bipolar I and am currently experiencing a major depressive episode.

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My depression is severe, based on my MADRS score.

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I have tried lithium, a mood stabilizer, and ECT without success.

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 major or unstable health conditions.

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I am unable to sign the informed consent.

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I have been treated for a psychiatric disorder other than depression in the last year.

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I cannot undergo surgery due to medical reasons or my surgeon's advice.

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I am not pregnant, breastfeeding, nor planning to become pregnant in the next 24 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 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

Evaluation of manic episodes utilizing the Altman Self-Rating Mania Scale (ASRM)

Evaluation of manic episodes utilizing the Young Mania Rating Scale (YMRS)

Utilizing the Montgomery-Asberg Depression Ratings Scale (MADRS) as a measurement of Efficacy

+1 more

Secondary study objectives

Durability of efficacy of the absence of recurring depressive episodes by utilizing the Clinical Global Impressions Scale (CGI-S)

Durability of efficacy of the absence of recurring depressive episodes by utilizing the Montgomery-Asberg Depression Ratings Scale (MADRS) .

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: One Month Blinded Discontinuation PeriodExperimental Treatment1 Intervention

The investigators will use blinded discontinuation at 12 months rather than sham control to establish evidence that response is dependent on ongoing DBS.

Group II: Medtronic Percept RC System Implantation for TRBDExperimental Treatment1 Intervention

All subjects will receive surgical implantation of Percept RC DBS system

0 / 10Eligibility criteria met