Stellate Ganglion Block for Major Depressive Disorder.

Study Overview
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Brief Summary
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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.

Official Title
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Stellate Ganglion Block for Major Depressive Disorder: A Randomized Controlled Pilot Trial

Conditions
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Treatment Resistant Depression, Major Depressive Disorder

Intervention / Treatment
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* Drug: Bupivacaine Hydrochloride
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine Hydrochloride<br>Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion. | Drug: Bupivacaine Hydrochloride<br>* Injection of Bupivacaine near the stellate ganglion<br>|
| Placebo Comparator: Normal Saline Solution<br>Injection of Normal Saline near the stellate ganglion | Drug: Normal Saline<br>* Injection of Normal Saline near the stellate ganglion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility, Recruitment, Acceptability, Safety, | Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feasibility trial, Stellate Ganglion Block, Bupivacaine