Stellate Ganglion Block for Major Depressive Disorder.

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04727229
• Other study ID #: 20-301
• Status: Completed
• Phase: Phase 4
• Start date: September 23, 2021
• Est. completion date: March 10, 2022

Study information

• Verified date: February 2024
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Ganglion Cysts
• Major Depressive Disorder
• Treatment Resistant Depression

Intervention

Drug:
• Bupivacaine Hydrochloride
Injection of Bupivacaine near the stellate ganglion
• Normal Saline
Injection of Normal Saline near the stellate ganglion

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 Tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, Recruitment, Acceptability, Safety,	Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events	1 year
Secondary	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