A Phase 4 interventional study of Bupivacaine Hydrochloride and Normal Saline in Treatment Resistant Depression and Major Depressive Disorder, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Unity Health Toronto · Phase 4, Interventional, and Other
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.
136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 101 interventional studies indexed under Ganglion Cysts.
Browse Ganglion Cysts studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion.
Drug: Bupivacaine Hydrochloride
Injection of Normal Saline near the stellate ganglion
Drug: Normal Saline
Injection of Bupivacaine near the stellate ganglion
Injection of Normal Saline near the stellate ganglion
Feasibility, Recruitment, Acceptability, Safety,
Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events
Time frame: 1 year
Change in the symptoms of depression
≥ 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
Time frame: 6 weeks
Plan to share: No — No individual participant data has been planned to be shared with other researchers at this point since this is a feasibility study with only 10 participants.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Unity Health Toronto