Recruiting
Phase 1
Phase 2

Deep Brain Stimulation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04009928

Conditions

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Active stimulation of the medial forebrain bundle or subcallosal cingulate

Sham stimulation

Study Details

Brief 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.

Conditions

Treatment Resistant Depression

Study ID

NCT04009928

Start date

Jun 15, 2019

Status verified date

Dec, 2023

Completion date

Dec 13, 2024

Anticipated

Primary completion date

Dec 13, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active followed by sham stimulation

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

sham comparator: Sham followed by active stimulation

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.

Interventions

Active stimulation of the medial forebrain bundle or subcallosal cingulate

Deep brain stimulation of the medial forebrain bundle or subcallosal cingulate

Sham stimulation

Sham stimulation for 2 weeks (Cross-over design)

Primary outcome measure

  • Safety: Qualitative report of any adverse events occurring up until 6 months postoperatively [ Time Frame: 6 months ]
  • Proportion of responders as measured by the Hamilton Depression Score (17-item version) at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Anusha Baskaran, PhD

Anusha.baskaran@sunnybrook.ca

Locations

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 5, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-12-05.