Stellate Ganglion Block for Major Depressive Disorder.

Phase 4

Completed

• Conditions: Treatment Resistant Depression; Major Depressive Disorder
• Interventions: Drug: Normal Saline; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT04727229
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-27
• Study Start: 2021-09-23
• Primary Completion: 2022-02-10
• Study Completion: 2022-03-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline Solution	Normal Saline	Injection of Normal Saline near the stellate ganglion
Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion.

Primary Outcome Measures

Name	Time	Method
Feasibility, Recruitment, Acceptability, Safety,	1 year	Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada