Home › Trials › NCT04009928
Clinical trial No longer in our active list Phase1; Phase2 Interventional Ages 20 to 80

Deep brain stimulation for treatment-resistant depression

Official title: Deep Brain Stimulation of the Medial Forebrain Bundle and Subcallosal Cingulate for the Treatment of Treatment Resistant Depression

Run by Sunnybrook Health Sciences Centre · NCT04009928 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing if deep brain stimulation can help people with treatment-resistant depression feel better.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages20 Years to 80 Years
SexAll
Enrollment10 (estimated)
SponsorSunnybrook Health Sciences Centre
Academic / other
Locations1 site (Toronto, Ontario)
Trial IDNCT04009928 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 20 to 80 with a diagnosis of major depressive disorder or bipolar II who have not responded to multiple standard treatments.

Probably not a fit

Patients who have not been diagnosed with major depressive disorder or bipolar II, or those who have not experienced treatment resistance may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of deep brain stimulation (DBS) targeting the medial forebrain bundle (MFB) and subcallosal cingulate cortex (SCC) in patients with treatment-resistant depression (TRD). Eight participants will initially receive DBS to the MFB, with stimulation starting two weeks post-surgery. After a six-month optimization phase, patients will be randomized to receive either active or sham stimulation for two weeks, followed by a washout period. The study aims to evaluate the effectiveness of DBS in alleviating depressive symptoms.

Why it matters

Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from treatment-resistant depression.

How similar studies have gone: Previous studies have shown promising results with DBS for depression, particularly with high response rates in small trials, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Men and women ≥20 and ≤80 years of age.
2. Patients who are able and willing to give consent and physically and practically able to attend study visits, as determined by both study Psychiatrist and the surgeon.
3. DSM-V diagnosis of major depressive disorder or bipolar II,
4. 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.
5. A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) when depressed)
6. Medication-refractoriness as determined by an adequate dose and duration of standard psychiatric treatments (including psychotherapy and/or pharmacology) as determined by two psychiatrists associated with the study. Including specifically:

   1. Failed to respond or tolerate adequate trial of three or more medications accepted as first line in the treatment of depression
   2. Failed to respond or tolerate augmentation with or combination of at least 2 medications known to be first line treatments for depression
   3. An adequate trial of cognitive behavioural therapy or other evidence-supported psychotherapy, delivered by a therapist experienced in treating depression
7. A consistent dose of any and all medications in the 30 days prior to study entry.
8. Women of childbearing potential must agree to use a contraception method throughout the study.

Exclusion Criteria:

1. Past or current evidence of psychosis or mania
2. Active neurologic disease, such as epilepsy
3. Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
4. Current active suicidal ideation
5. Any contraindication to MRI scanning
6. Presence of significant cognitive impairment
7. Likely to relocate or move out of the country during the study's duration
8. Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
9. Currently pregnant (as determined by history and serum HCG) or lactating; for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

Where it's running

  • Sunnybrook Health Sciences Center
    Toronto, Ontario, Canada     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Treatment Resistant Depression 69Sunnybrook Health Sciences Centre 93
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.