Stellate Ganglion Block for Major Depressive Disorder.

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Treatment Resistant Depression
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 - 65 years of age
2. Major depressive disorder without psychotic symptoms according to DSM-5 criteria
3. Hamilton Depression Rating Scale (HAMD)>17
4. Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI)
5. Failure of at least two trials of antidepressant therapy during the current episode
6. Capacity to provide informed consent

Exclusion Criteria:

1. Depression secondary to stroke, cancer or other severe medical illness
2. Major Depressive Episode in people with Bipolar Disorder.
3. Dementia
4. Post-Traumatic Stress Disorder (PTSD)
5. Acute suicidality defined as score ≥3 on HAMD item 3
6. Previous electroconvulsive therapy
7. Known history of intolerance of hypersensitivity to local anesthetic
8. 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
9. Unwilling to maintain current antidepressant regimen.
10. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Karim Ladha, MD, Unity Health Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): March 10, 2022

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Bupivacaine; Feasibility trial; Stellate Ganglion Block
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Neoplasms; Cysts; Connective Tissue Diseases; Mucinoses; Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Ganglion Cysts; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 20-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No