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Device

Deep Brain Stimulation for Treatment Resistant Depression

Phase 1 & 2

Recruiting

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

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

Must have

DSM-V diagnosis of major depressive disorder or bipolar II

At least 5-year illness history of the primary disorder and at least 6 months since the onset of the first episode of major depression.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing whether deep brain stimulation (DBS) to either the medial forebrain bundle (MFB) or the subcallosal cingulate cortex (SCC) can help people with treatment resistant depression (TRD).

Who is the study for?

This trial is for adults aged 20-80 with severe depression that hasn't improved after trying at least three first-line medications and two augmentation treatments. Participants must have a long-term history of depression, be able to attend study visits, and women must agree to use contraception during the study.Check my eligibility

What is being tested?

The trial is testing Deep Brain Stimulation (DBS) targeting either the medial forebrain bundle or subcallosal cingulate in people with treatment-resistant depression. It's a randomized trial comparing active stimulation against sham (fake) stimulation to see if it can improve symptoms.See study design

What are the potential side effects?

While not specified here, DBS side effects may include headache, seizure, infection at the implant site, mood changes, or issues related to device malfunction.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with major depression or bipolar II.

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I have been diagnosed with my primary disorder for over 5 years and experienced my first major depression episode more than 6 months ago.

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I am between 20 and 80 years old.

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I have tried at least 2 first-line depression treatments without success.

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I have tried three or more depression medications without success.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Proportion of responders as measured by the Hamilton Depression Score (17-item version) at 6 months

Safety: Qualitative report of any adverse events occurring up until 6 months postoperatively

Secondary outcome measures

Beck Depression Inventory at 12 months

Hamilton Depression score (17-item version) at 12 months

Mean Hamilton Depression Score (17-item version) at the end of the sham-stimulation compared with at the end of the true-stimulation

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active followed by sham stimulationExperimental Treatment2 Interventions

2 weeks of active stimulation of the medial forebrain bundle or subcallosal cingulate at the optimized stimulation settings derived during the open-label phase. After 1 week of washout period (with no stimulation), subjects undergo 2 weeks of sham stimulation

Group II: Sham followed by active stimulationPlacebo Group2 Interventions

2 weeks of sham-stimulation, followed by 2 weeks of active stimulation, separated with 1 week washout period. This is a crossover study, patients will undergo both arms, the order of which they do is randomized.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sham stimulation

2006

Completed Phase 3

~1040

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,298 Total Patients Enrolled

Frequently Asked Questions

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

Are there any spots available for prospective participants in this experiment?

"Affirmative. Clinicaltrials.gov holds records of this experiment being actively recruiting participants, which commenced recruitment on June 15th 2019 and was last edited on December 1st 2023. There are 10 vacancies at a single medical centre for qualified candidates to join the trial."

Answered by AI

Does this clinical trial incorporate individuals who are over forty years old?

"This clinical trial is enlisting patients between the ages of 20 and 80."

Answered by AI

What is the current size of this research endeavor's participant pool?

"Affirmative. According to the information stored on clinicaltrials.gov, this research study is actively recruiting participants and was initially posted on June 15th 2019 with its most recent amendments made on December 1st 2023. The trial requires 10 patients for enrolment at one specific medical site."

Answered by AI

What objectives does this clinical investigation intend to meet?

"This 6-month trial will evaluate the effectiveness of its intervention by measuring patients' Hamilton Depression Score (17-item version) at 6 months. Secondary outcomes include mean Beck Depression Inventory at 12 months, which is a 21-point scale with lower numbers indicating more severe depression; another secondary outcome is assessing the Mean Hamilton Depression Score after sham and true stimulation via blinded crossover portion of study. Lastly, Montgomery Asberg Depression Rating Scale at 12 months will be measured to determine Proportion of responders who achieved 40% or greater decrease in their rating compared to preoperative baseline - this 10-point scale has higher scores correlating with greater severity."

Answered by AI

What criteria must individuals meet to be considered as participants in this experiment?

"This clinical trial is seeking 10 participants with major depressive disorder and aged between 20 to 80 years old. The criteria for enrolment includes being male or female, having a DSM-V diagnosis of major depression or bipolar II, scoring at least 20 on the HAMD scale while depressed, have taken 3 medication treatments that are accepted as first line in treating depression without success or intolerance, undergone cognitive behavioural therapy from an experienced therapist yet still failed to respond well and be using consistent doses of medications prior to entering the study. Furthermore, women who may childbearing potential must agree to use contraception throughout the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Deep Brain Stimulation for Treatment Resistant Depression

Dr. Nir Lipsman 2019. "Deep Brain Stimulation for Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04009928.