Stellate Ganglion Block for Major Depressive Disorder.

Unity Health Toronto (Other)
Overall Status
Completed ID

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
  • Drug: Bupivacaine Hydrochloride
  • Drug: Normal Saline
Phase 4

Study Design

Study Type:
Actual Enrollment :
10 participants
Intervention Model:
Parallel Assignment
Double (Participant, Investigator)
Primary Purpose:
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

Outcome Measures

Primary Outcome Measures

  1. Feasibility, Recruitment, Acceptability, Safety, [1 year]

    Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events

Secondary Outcome Measures

  1. 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


Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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).

Contacts and Locations


Site City State Country Postal Code
1 St. Michael's Hospital Toronto Ontario Canada M5B 1W8

Sponsors and Collaborators

  • Unity Health Toronto


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Unity Health Toronto Identifier:
Other Study ID Numbers:
  • 20-301
First Posted:
Jan 27, 2021
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Unity Health Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022