Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant Depression
Background With nearly one-third of patients with major depressive disorder being resistant to available antidepressants, there is a need to develop new treatments for this population. Stellate ganglion block (SGB) is a procedure used to block sympathetic input to the central autonomic system; it ha...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2023-03-01
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| Series: | Chronic Stress |
| Online Access: | https://doi.org/10.1177/24705470231160315 |
| _version_ | 1811160390930792448 |
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| author | David Sussman Vanessa K Tassone Fatemeh Gholamali Nezhad Michelle Wu Fathima Adamsahib Gabriella F Mattina Janneth Pazmino-Canizares Ilya Demchenko Hyejung Jung Wendy Lou Karim S Ladha Venkat Bhat |
| author_facet | David Sussman Vanessa K Tassone Fatemeh Gholamali Nezhad Michelle Wu Fathima Adamsahib Gabriella F Mattina Janneth Pazmino-Canizares Ilya Demchenko Hyejung Jung Wendy Lou Karim S Ladha Venkat Bhat |
| author_sort | David Sussman |
| collection | DOAJ |
| description | Background With nearly one-third of patients with major depressive disorder being resistant to available antidepressants, there is a need to develop new treatments for this population. Stellate ganglion block (SGB) is a procedure used to block sympathetic input to the central autonomic system; it has been administered to treat several conditions, including pain. Recently, indications for SGB have extended and the potential benefits for psychiatric disorders are under investigation. Methods The Local Injection For Treating Mood Disorders (LIFT-MOOD) study investigated the feasibility of a trial of 2 right-sided injections of bupivacaine 0.5% (7 mL) at the stellate ganglion in participants with treatment-resistant depression (TRD) using a randomized, placebo-controlled, pilot trial. Ten participants were randomized in a 1:1 allocation to receive active treatment or placebo (saline). Primary feasibility outcomes included recruitment rate, withdrawal, adherence, missing data, and adverse events. As a secondary, exploratory objective, we explored the efficacy of SGB in improving symptoms of depression by calculating the change in scores from baseline to follow-up on day 42 for each treatment group. Results The recruitment rate was reasonable and sufficient, retention and adherence were high, missing data were low, and adverse events were mild and temporary. Both treatment groups demonstrated decreases in Montgomery-Åsberg Depression Rating Scale scores, compared to baseline, by the end of the study. Conclusion This study supports the feasibility of a confirmatory trial of SGB in participants with TRD. Conclusions regarding efficacy cannot be made based on this preliminary study due to the small number of participants who completed active treatment. Larger-scale randomized controlled trials with long-term follow-ups and alternate sham procedures are needed to assess the efficacy and duration of symptom improvement with the use of SGB in TRD. |
| first_indexed | 2024-04-10T05:57:41Z |
| format | Article |
| id | doaj.art-cc920d570b2d4b00bddfe293ba636482 |
| institution | Directory Open Access Journal |
| issn | 2470-5470 |
| language | English |
| last_indexed | 2024-04-10T05:57:41Z |
| publishDate | 2023-03-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Chronic Stress |
| spelling | doaj.art-cc920d570b2d4b00bddfe293ba6364822023-03-03T11:33:10ZengSAGE PublishingChronic Stress2470-54702023-03-01710.1177/24705470231160315Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant DepressionDavid Sussman0Vanessa K Tassone1Fatemeh Gholamali Nezhad2Michelle Wu3Fathima Adamsahib4Gabriella F Mattina5Janneth Pazmino-Canizares6Ilya Demchenko7Hyejung Jung8Wendy Lou9Karim S Ladha10Venkat Bhat11 Department of Anesthesia, St. Michael's Hospital, Toronto, Ontario, Canada Interventional Psychiatry Program, St. Michael's Hospital, Toronto, Ontario, Canada Interventional Psychiatry Program, St. Michael's Hospital, Toronto, Ontario, Canada Interventional Psychiatry Program, St. Michael's Hospital, Toronto, Ontario, Canada Interventional Psychiatry Program, St. Michael's Hospital, Toronto, Ontario, Canada Department of Anesthesia, St. Michael's Hospital, Toronto, Ontario, Canada Department of Anesthesia, St. Michael's Hospital, Toronto, Ontario, Canada Temerty Faculty of Medicine, Institute of Medical Science, , Toronto, Ontario, Canada Department of Biostatistics, Dalla Lana School of Public Health, , Toronto, Ontario, Canada Department of Biostatistics, Dalla Lana School of Public Health, , Toronto, Ontario, Canada Department of Anesthesia, St. Michael's Hospital, Toronto, Ontario, Canada Department of Psychiatry, Temerty Faculty of Medicine, , Toronto, Ontario, CanadaBackground With nearly one-third of patients with major depressive disorder being resistant to available antidepressants, there is a need to develop new treatments for this population. Stellate ganglion block (SGB) is a procedure used to block sympathetic input to the central autonomic system; it has been administered to treat several conditions, including pain. Recently, indications for SGB have extended and the potential benefits for psychiatric disorders are under investigation. Methods The Local Injection For Treating Mood Disorders (LIFT-MOOD) study investigated the feasibility of a trial of 2 right-sided injections of bupivacaine 0.5% (7 mL) at the stellate ganglion in participants with treatment-resistant depression (TRD) using a randomized, placebo-controlled, pilot trial. Ten participants were randomized in a 1:1 allocation to receive active treatment or placebo (saline). Primary feasibility outcomes included recruitment rate, withdrawal, adherence, missing data, and adverse events. As a secondary, exploratory objective, we explored the efficacy of SGB in improving symptoms of depression by calculating the change in scores from baseline to follow-up on day 42 for each treatment group. Results The recruitment rate was reasonable and sufficient, retention and adherence were high, missing data were low, and adverse events were mild and temporary. Both treatment groups demonstrated decreases in Montgomery-Åsberg Depression Rating Scale scores, compared to baseline, by the end of the study. Conclusion This study supports the feasibility of a confirmatory trial of SGB in participants with TRD. Conclusions regarding efficacy cannot be made based on this preliminary study due to the small number of participants who completed active treatment. Larger-scale randomized controlled trials with long-term follow-ups and alternate sham procedures are needed to assess the efficacy and duration of symptom improvement with the use of SGB in TRD.https://doi.org/10.1177/24705470231160315 |
| spellingShingle | David Sussman Vanessa K Tassone Fatemeh Gholamali Nezhad Michelle Wu Fathima Adamsahib Gabriella F Mattina Janneth Pazmino-Canizares Ilya Demchenko Hyejung Jung Wendy Lou Karim S Ladha Venkat Bhat Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant Depression Chronic Stress |
| title | Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant Depression |
| title_full | Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant Depression |
| title_fullStr | Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant Depression |
| title_full_unstemmed | Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant Depression |
| title_short | Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant Depression |
| title_sort | local injection for treating mood disorders lift mood a pilot feasibility rct of stellate ganglion block for treatment resistant depression |
| url | https://doi.org/10.1177/24705470231160315 |
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