Status:
COMPLETED
Stellate Ganglion Block for Major Depressive Disorder.
Lead Sponsor:
Unity Health Toronto
Conditions:
Treatment Resistant Depression
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 symp...
Eligibility Criteria
Inclusion
- 18 - 65 years of age
- Major depressive disorder without psychotic symptoms according to DSM-5 criteria
- Hamilton Depression Rating Scale (HAMD)\>17
- Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Failure of at least two trials of antidepressant therapy during the current episode
- Capacity to provide informed consent
Exclusion
- Depression secondary to stroke, cancer or other severe medical illness
- Major Depressive Episode in people with Bipolar Disorder.
- Dementia
- Post-Traumatic Stress Disorder (PTSD)
- Acute suicidality defined as score ≥3 on HAMD item 3
- Previous electroconvulsive therapy
- Known history of intolerance of hypersensitivity to local anesthetic
- 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
- Unwilling to maintain current antidepressant regimen.
- 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).
Key Trial Info
Start Date :
September 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04727229
Start Date
September 23 2021
End Date
March 10 2022
Last Update
February 9 2024
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8