Major Depressive Disorder, Treatment Resistant Depression
Conditions
Keywords
Feasibility trial, Stellate Ganglion Block, Bupivacaine
Brief summary
This is a feasibility study, to investigate a new treatment option for major depressive disorders by performing a Stellate Ganglion Block (SGB). A SGB is an injection of local anesthetic into the sympathetic nervous system (peripheral nervous system) located in the lower part of the neck, to relieve pain in the head, neck, upper arm, and upper chest.
Interventions
DRUGBupivacaine Hydrochloride
Injection of Bupivacaine near the stellate ganglion
DRUGNormal Saline
Injection of Normal Saline near the stellate ganglion
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18 - 65 years of age 2. Major depressive disorder without psychotic symptoms according to DSM-5 criteria 3. Hamilton Depression Rating Scale (HAMD)\>17 4. Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI) 5. Failure of at least two trials of antidepressant therapy during the current episode 6. Capacity to provide informed consent
Exclusion criteria
1. Depression secondary to stroke, cancer or other severe medical illness 2. Major Depressive Episode in people with Bipolar Disorder. 3. Dementia 4. Post-Traumatic Stress Disorder (PTSD) 5. Acute suicidality defined as score ≥3 on HAMD item 3 6. Previous electroconvulsive therapy 7. Known history of intolerance of hypersensitivity to local anesthetic 8. Current substance abuse or dependence (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of current alcohol abuse or dependence, as defined in DSM-5 criteria 9. Unwilling to maintain current antidepressant regimen. 10. A clinical finding/condition that is unstable or that, in the opinion of the investigator(s) would negatively be affected by an SGB (e.g. movement disorder where patient is unable to lie still for injection or anatomical variants making an SGB impractical).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility, Recruitment, Acceptability, Safety, | 1 year | Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the symptoms of depression | 6 weeks | ≥ 50% reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score. The MADRS score range from 0 to 6 = no depression; from 7 to 19 = mild depression, 20 to 34 = moderate depression, 35 and greater = severe depression, and a total score of 60 or greater = very severe depression |
Countries
Canada
Outcome results
None listed