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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

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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