Treatment Resistant DepressionPhase 4NCT04727229
Stellate Ganglion Block for Major Depressive Disorder.
A Phase 4 study testing Bupivacaine Hydrochloride and Normal Saline in people with Treatment Resistant Depression and Major Depressive Disorder, run by Unity Health Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression, Major Depressive Disorder
- What is being tested?
- Bupivacaine Hydrochloride and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 23 Sep 2021to 10 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stellate Ganglion Block for Major Depressive Disorder: A Randomized Controlled Pilot Trial
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.
- Being tested
- Bupivacaine Hydrochloride, Normal Saline
- Keywords
- Feasibility trial, Stellate Ganglion Block, Bupivacaine
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Injection of Bupivacaine near the stellate ganglion
Normal SalineDrug
Injection of Normal Saline near the stellate ganglion
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Hydrochloride | Experimental | Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion. Receives: Drug: Bupivacaine Hydrochloride |
| Normal Saline Solution | Placebo comparator | Injection of Normal Saline near the stellate ganglion Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, Recruitment, Acceptability, Safety,
Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events
Measured: 1 year
Secondary outcomes (1)
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start23 Sep 2021
- Primary completion10 Feb 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Ladha, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727229
- Sponsor's protocol ID
- 20-301
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36895443
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Block for Major Depressive Disorder: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT04727229
- Acronym / sponsor ID
- 20-301
- Keywords
- Feasibility trial, Stellate Ganglion Block, Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Hydrochloride | Experimental | Drug: Bupivacaine HydrochlorideInjection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion. |
| Normal Saline Solution | Placebo comparator | Drug: Normal SalineInjection of Normal Saline near the stellate ganglion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine HydrochlorideInjection of Bupivacaine near the stellate ganglion | Drug | Bupivacaine Hydrochloride |
| Normal SalineInjection of Normal Saline near the stellate ganglion | Drug | Normal Saline Solution |
Primary outcome
Feasibility, Recruitment, Acceptability, Safety,
Time frame: 1 year
Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events
1 secondary outcome
Change in the symptoms of depression
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Results publication: PubMed 36895443Sussman 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Ladha, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Hydrochloride and Normal Saline in people with Treatment Resistant Depression and Major Depressive Disorder, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, Recruitment, Acceptability, Safety, (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04727229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.