Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant Depression

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, 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

Abstract

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.

Keywords: anesthesia; depression; stellate ganglion; stellate ganglion block; sympathetic block; treatment-resistant depression.

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: KSL is supported in part by Merit Awards from the Department of Anesthesiology and Pain Medicine at the University of Toronto and is a co-principal investigator of a study funded by Shoppers Drug Mart. VB is supported by an Academic Scholar Award from the University of Toronto Department of Psychiatry and has received research support from the Canadian Institutes of Health Research, Brain & Behavior Foundation, Ontario Ministry of Health Innovation Funds, Royal College of Physicians and Surgeons of Canada, Department of National Defence (Government of Canada), New Frontiers in Research Fund, Associated Medical Services Inc. Healthcare, American Foundation for Suicide Prevention, Roche Canada, Novartis, and Eisai.

© The Author(s) 2023.

Figures

Figure 1.
Figure 1.
Study design. TRD, treatment-resistant depression.
Figure 2.
Figure 2.
Adverse event occurrences by group with percent and frequency counts. SGB, stellate ganglion block.
Figure 3.
Figure 3.
Frequency of specific adverse events across all participants.
Figure 4.
Figure 4.
Total scores of scales (A) MADRS, (B) QIDS-SR, (C) GAD-7, and (D) Q-LES-Q for both treatment groups. MADRS, Montgomery-Åsberg Depression Rating Scale; QIDS-SR, Quick Inventory of Depressive Symptomatology – Self Report; GAD-7, Generalized Anxiety Disorder 7-item; Q-LES-Q, Quality-of-Life Enjoyment and Satisfaction; SGB, stellate ganglion block.

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