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Completed

NCT Number: NCT04727229

Stellate Ganglion Block for Major Depressive Disorder.

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.

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bupivacaine Hydrochloride

Drug

Injection of Bupivacaine near the stellate ganglion

normal saline

Drug

Injection of Normal Saline near the stellate ganglion

Primary outcomes

  1. Feasibility, Recruitment, Acceptability, Safety,

    Time frame: 1 year

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

Secondary outcomes

  1. Change in the symptoms of depression

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2021
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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