Status:
UNKNOWN
Deep Brain Stimulation for Treatment Resistant Depression
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
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...
Detailed 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 init...
Eligibility Criteria
Inclusion
- Men and women ≥20 and ≤80 years of age.
- 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.
- 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.
- A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) when depressed)
- 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:
- Failed to respond or tolerate adequate trial of three or more medications accepted as first line in the treatment of depression
- Failed to respond or tolerate augmentation with or combination of at least 2 medications known to be first line treatments for depression
- An adequate trial of cognitive behavioural therapy or other evidence-supported psychotherapy, delivered by a therapist experienced in treating depression
- A consistent dose of any and all medications in the 30 days prior to study entry.
- Women of childbearing potential must agree to use a contraception method throughout the study.
Exclusion
- Past or current evidence of psychosis or mania
- Active neurologic disease, such as epilepsy
- Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- Current active suicidal ideation
- Any contraindication to MRI scanning
- Presence of significant cognitive impairment
- Likely to relocate or move out of the country during the study's duration
- Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
- 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
Key Trial Info
Start Date :
June 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 13 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04009928
Start Date
June 15 2019
End Date
December 13 2024
Last Update
December 5 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5