Deep brain stimulation for treatment-resistant depression

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

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

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT04009928 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Toronto, Ontario

• Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Anusha Baskaran, PhD

Conditions Treatment Resistant Depression