Deep Brain Stimulation for Treatment Resistant Depression

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Jul 3, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for people with treatment-resistant depression (TRD), which means they have not responded to standard therapies like medications or therapy. The study will compare two different brain stimulation targets: the medial forebrain bundle (MFB) and the subcallosal cingulate cortex (SCC). Researchers hope to see if stimulating these areas of the brain can help improve depression symptoms more effectively than traditional treatments.

To participate, individuals must be between 20 and 80 years old and have a diagnosis of major depressive disorder or bipolar II. They should have a long history of depression and have tried multiple medications and therapies without success. Participants will receive either the brain stimulation treatment or a placebo (a non-active treatment) and will be monitored closely throughout the study. It’s important for potential participants to know that they must be able to attend study visits and meet certain health criteria. This trial is currently recruiting individuals who are looking for new hope in their battle against depression.

Gender

ALL

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