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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine Hydrochloride | Experimental | Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion. |
|
| Normal Saline Solution | Placebo Comparator | Injection of Normal Saline near the stellate ganglion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Drug | Injection of Bupivacaine near the stellate ganglion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, Recruitment, Acceptability, Safety, | Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karim Ladha, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36895443 | Result | Sussman D, Tassone VK, Gholamali Nezhad F, Wu M, Adamsahib F, Mattina GF, Pazmino-Canizares J, Demchenko I, Jung H, Lou W, Ladha KS, Bhat V. Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant Depression. Chronic Stress (Thousand Oaks). 2023 Mar 3;7:24705470231160315. doi: 10.1177/24705470231160315. eCollection 2023 Jan-Dec. |
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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.
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Normal Saline | Drug | Injection of Normal Saline near the stellate ganglion |
|
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |