Last updated: February 7, 2024
Sponsor: Unity Health Toronto
Overall Status: Completed
Phase
4
Condition
Depression
Affective Disorders
Depression (Major/severe)
Treatment
Bupivacaine Hydrochloride
Normal Saline
Clinical Study ID
NCT04727229
20-301
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 InternationalNeuropsychiatric Interview (MINI)
- Failure of at least two trials of antidepressant therapy during the current episode
- Capacity to provide informed consent
Exclusion
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, asdefined in DSM-5 criteria
- Unwilling to maintain current antidepressant regimen.
- A clinical finding/condition that is unstable or that, in the opinion of theinvestigator(s) would negatively be affected by an SGB (e.g. movement disorder wherepatient is unable to lie still for injection or anatomical variants making an SGBimpractical).
Study Design
Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Bupivacaine Hydrochloride
Phase: 4
Study Start date:
September 23, 2021
Estimated Completion Date:
March 10, 2022
Connect with a study center
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.