Deep Brain Stimulation for Treatment Resistant Depression

Last updated: December 1, 2023
Sponsor: Sunnybrook Health Sciences Centre
Overall Status: Active - Recruiting

Phase

1/2

Condition

Depression

Treatment

Active stimulation of the medial forebrain bundle or subcallosal cingulate

Sham stimulation

Clinical Study ID

NCT04009928
277-2018
  • Ages 20-80
  • All Genders

Study Summary

Treatment resistant depression (TRD) is a major global health concern, and there is a crucial need to develop novel effective treatments.

The medial forebrain bundle (MFB) is a recently described DBS target, with reported rapid onset of antidepressant effects. A recent small randomized trial reported a 100% response rate. The subcallosal cingulate cortex (SCC) is the most commonly used target in DBS for depression.

Herein, the investigators will conduct a sham-controlled randomized trial of DBS to the MFB or SCC for TRD.

Eligibility Criteria

Inclusion

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 ableto 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 sincethe 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 standardpsychiatric treatments (including psychotherapy and/or pharmacology) as determined bytwo psychiatrists associated with the study. Including specifically:
  7. Failed to respond or tolerate adequate trial of three or more medicationsaccepted as first line in the treatment of depression
  8. Failed to respond or tolerate augmentation with or combination of at least 2medications known to be first line treatments for depression
  9. An adequate trial of cognitive behavioural therapy or other evidence-supportedpsychotherapy, delivered by a therapist experienced in treating depression
  10. A consistent dose of any and all medications in the 30 days prior to study entry.
  11. Women of childbearing potential must agree to use a contraception method throughoutthe study.

Exclusion

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 andnicotine
  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 increasethe risk of the surgical procedure.
  9. Currently pregnant (as determined by history and serum HCG) or lactating; for femalesof reproductive potential: use of highly effective contraception for at least 1 monthprior to screening and agreement to use such a method during study participation

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Active stimulation of the medial forebrain bundle or subcallosal cingulate
Phase: 1/2
Study Start date:
June 15, 2019
Estimated Completion Date:
December 13, 2024

Study Description

Eight patients with TRD will be treated with DBS to the MFB. At approximately 2 weeks postoperartively, stimulation will be initiated in all patients. Voltage and contact position will be altered initially, looking for optimal and stabilized responses in depressive symptoms, while trying to minimize any side effects.

Following this 6 month open-label optimization phase, patients will be then undergo randomization to receive 2 weeks of stimulation followed by 2 weeks of sham stimulation, or vice versa. These 2 week phases will be separated by a 1 week washout period. Depressive symptoms will be evaluated at the end of each 2 week phase, then patients will resume open-label stimiulation.

Connect with a study center

  • Sunnybrook Health Sciences Center

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

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