Stellate Ganglion Block for Major Depressive Disorder.

Last updated: February 7, 2024
Sponsor: Unity Health Toronto
Overall Status: Completed

Phase

4

Condition

Depression

Affective Disorders

Depression (Major/severe)

Treatment

Bupivacaine Hydrochloride

Normal Saline

Clinical Study ID

NCT04727229
20-301
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 InternationalNeuropsychiatric Interview (MINI)
  5. Failure of at least two trials of antidepressant therapy during the current episode
  6. Capacity to provide informed consent

Exclusion

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, asdefined 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 theinvestigator(s) would negatively be affected by an SGB (e.g. movement disorder wherepatient is unable to lie still for injection or anatomical variants making an SGBimpractical).

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Bupivacaine Hydrochloride
Phase: 4
Study Start date:
September 23, 2021
Estimated Completion Date:
March 10, 2022

Connect with a study center

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

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