Stellate Ganglion Block for Major Depressive Disorder.

Sponsor

Unity Health Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT04727229

Collaborator

(none)

Enrollment

Location

Arms

5.5

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Treatment Resistant Depression Major Depressive Disorder	Drug: Bupivacaine Hydrochloride Drug: Normal Saline	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 23, 2021

Actual Primary Completion Date :

Feb 10, 2022

Actual Study Completion Date :

Mar 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupivacaine Hydrochloride Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion.	Drug: Bupivacaine Hydrochloride Injection of Bupivacaine near the stellate ganglion
Placebo Comparator: Normal Saline Solution Injection of Normal Saline near the stellate ganglion	Drug: Normal Saline Injection of Normal Saline near the stellate ganglion

Arm

Intervention/Treatment

Experimental: Bupivacaine Hydrochloride

Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion.

Drug: Bupivacaine Hydrochloride

Injection of Bupivacaine near the stellate ganglion

Placebo Comparator: Normal Saline Solution

Injection of Normal Saline near the stellate ganglion

Drug: Normal Saline

Injection of Normal Saline near the stellate ganglion

Outcome Measures

Primary Outcome Measures

Feasibility, Recruitment, Acceptability, Safety, [1 year]
Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).