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Stellate Ganglion Block for Major Depressive Disorder.

Primary Purpose

Treatment Resistant Depression, Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Bupivacaine Hydrochloride

Normal Saline

About this trial

This is an interventional other trial for Treatment Resistant Depression focused on measuring Feasibility trial, Stellate Ganglion Block, Bupivacaine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bupivacaine Hydrochloride

Normal Saline Solution

Arm Description

Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion.

Injection of Normal Saline near the stellate ganglion

Outcomes

Primary Outcome Measures

Feasibility, Recruitment, Acceptability, Safety,

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04727229

First Posted

January 22, 2021

Last Updated

May 27, 2022

Sponsor

Unity Health Toronto

1. Study Identification

Unique Protocol Identification Number

NCT04727229

Brief Title

Stellate Ganglion Block for Major Depressive Disorder.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

September 23, 2021 (Actual)

Primary Completion Date

February 10, 2022 (Actual)

Study Completion Date

March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment Resistant Depression, Major Depressive Disorder

Keywords

Feasibility trial, Stellate Ganglion Block, Bupivacaine

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bupivacaine Hydrochloride

Arm Type

Experimental

Arm Description

Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion.

Arm Title

Normal Saline Solution

Arm Type

Placebo Comparator

Arm Description

Injection of Normal Saline near the stellate ganglion

Intervention Type

Drug

Intervention Name(s)

Bupivacaine Hydrochloride

Intervention Description

Injection of Bupivacaine near the stellate ganglion

Intervention Type

Drug

Intervention Name(s)

Normal Saline

Intervention Description

Injection of Normal Saline near the stellate ganglion

Primary Outcome Measure Information:

Title

Feasibility, Recruitment, Acceptability, Safety,

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Change in the symptoms of depression

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karim Ladha, MD

Organizational Affiliation

Unity Health Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No individual participant data has been planned to be shared with other researchers at this point since this is a feasibility study with only 10 participants.

Learn more about this trial

Stellate Ganglion Block for Major Depressive Disorder.

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