NCT04727229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

September 23, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

January 22, 2021

Last Update Submit

February 7, 2024

Conditions

Treatment Resistant DepressionMajor Depressive Disorder

Keywords

Feasibility trialStellate Ganglion BlockBupivacaine

Outcome Measures

Primary Outcomes (1)

  • Feasibility, Recruitment, Acceptability, Safety,

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

    1 year

Secondary Outcomes (1)

  • Change in the symptoms of depression

    6 weeks

Study Arms (2)

Bupivacaine Hydrochloride

EXPERIMENTAL

Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion.

Drug: Bupivacaine Hydrochloride

Normal Saline Solution

PLACEBO COMPARATOR

Injection of Normal Saline near the stellate ganglion

Drug: Normal Saline

Interventions

Bupivacaine HydrochlorideDRUG

Injection of Bupivacaine near the stellate ganglion

Bupivacaine Hydrochloride
Normal SalineDRUG

Injection of Normal Saline near the stellate ganglion

Normal Saline Solution

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related 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 Treatment-Resistant Depression. Chronic Stress (Thousand Oaks). 2023 Mar 3;7:24705470231160315. doi: 10.1177/24705470231160315. eCollection 2023 Jan-Dec.

    PMID: 36895443RESULT

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantDepressive Disorder, Major

Interventions

BupivacaineSaline Solution

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Karim Ladha, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 27, 2021

Study Start

September 23, 2021

Primary Completion

February 10, 2022

Study Completion

March 10, 2022

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

CA(1)