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Stellate Ganglion Block for Major Depressive Disorder.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04727229
Recruitment Status : Completed
First Posted : January 27, 2021
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Major Depressive Disorder Drug: Bupivacaine Hydrochloride Drug: Normal Saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Stellate Ganglion Block for Major Depressive Disorder: A Randomized Controlled Pilot Trial
Actual Study Start Date : September 23, 2021
Actual Primary Completion Date : February 10, 2022
Actual Study Completion Date : March 10, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bupivacaine Hydrochloride
Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion.
 Drug: Bupivacaine Hydrochloride
Injection of Bupivacaine near the stellate ganglion
Placebo Comparator: Normal Saline Solution
Injection of Normal Saline near the stellate ganglion
 Drug: Normal Saline
Injection of Normal Saline near the stellate ganglion


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility, Recruitment, Acceptability, Safety, [ Time Frame: 1 year ]
    Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727229


Locations
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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: Karim Ladha, MD Unity Health Toronto
More Information
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT04727229    
Other Study ID Numbers: 20-301
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Health Toronto:
Feasibility trial
Stellate Ganglion Block
Bupivacaine
Additional relevant MeSH terms:
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Ganglion Cysts
Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cysts
Neoplasms
 Mucinoses
Connective Tissue Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents