At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: Findings from a large, prospective, open-label effectiveness trial
This open-label (real-world evidence) paper (n=1247) argues that at-home sublingual ketamine (tablets for under the tongue) is both safe (only four patients dropped out) and effective (remission of 32% for depression and anxiety). Patients only spoke with a 'guide' (not a therapist) over video as the study was conducted during Covid. The results look promising, though the study sponsor (Mindbloom) has come under scrutiny recently.
Authors
- Adam Gazzaley
Published
Abstract
Background
At-home Ketamine-assisted therapy (KAT) with psychosocial support and remote monitoring through telehealth platforms addresses access barriers, including the COVID-19 pandemic. Large-scale evaluation of this approach is needed for questions regarding safety and effectiveness for depression and anxiety.
Methods
In this prospective study, a large outpatient sample received KAT over four weeks through a telehealth provider. Symptoms were assessed using the Patient Health Questionnaire (PHQ-9) for depression, and the Generalized Anxiety Disorder scale (GAD-7) for anxiety. Demographics, adverse events, and patient-reported dissociation were also analyzed. Symptom trajectories were identified using Growth Mixture Modeling, along with outcome predictors.
Results
A sample of 1247 completed treatment with sufficient data, 62.8 % reported a 50 % or greater improvement on the PHQ-9, d = 1.61, and 62.9 % on the GAD-7, d = 1.56. Remission rates were 32.6 % for PHQ-9 and 31.3 % for GAD-7, with 0.9 % deteriorating on the PHQ-9, and 0.6 % on the GAD-7. Four patients left treatment early due to side effects or clinician disqualification, and two more due to adverse events. Three patient subpopulations emerged, characterized by Improvement (79.3 %), Chronic (11.4 %), and Delayed Improvement (9.3 %) for PHQ-9 and GAD-7. Endorsing side effects at Session 2 was associated with delayed symptom improvement, and Chronic patients were more likely than the other two groups to report dissociation at Session 4.
Conclusion
At-home KAT response and remission rates indicated rapid and significant antidepressant and anxiolytic effects. Rates were consistent with laboratory- and clinic-administered ketamine treatment. Patient screening and remote monitoring maintained low levels of adverse events. Future research should assess durability of effects.
Research Summary of 'At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: Findings from a large, prospective, open-label effectiveness trial'
Introduction
Depressive and anxiety disorders are major and growing contributors to disability, and existing treatment capacity and effectiveness are increasingly seen as inadequate. Earlier research has documented rapid symptom reductions with compounds that have dissociative or psychedelic properties, and ketamine in particular has substantial evidence from intravenous (IV) and intramuscular (IM) studies; sublingual and intranasal forms are emerging because they are easier to deliver. At the same time, telemedicine and remote monitoring have expanded access to mental healthcare, but large-scale evidence is needed on safety and effectiveness when ketamine is delivered at home with psychosocial support via telehealth. Hull and colleagues set out to evaluate the real-world safety and effectiveness of an at-home, sublingual ketamine-assisted therapy (KAT) model delivered through a telemedicine platform. The prospective, open-label study aimed to characterise symptom change in depression and anxiety over four weeks, document adverse events and dissociative reactions, and identify distinct patient response trajectories and their predictors using observational clinical records and routine outcome measures.
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Study Details
- Study Typeindividual
- Journal
- Compound
- Topics
- Author
- APA Citation
Hull, T. D., Malgaroli, M., Gazzaley, A., Akiki, T. J., Madan, A., Vando, L., Arden, K., Swain, J., Klotz, M., & Paleos, C. (2022). At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: Findings from a large, prospective, open-label effectiveness trial. Journal of Affective Disorders, 314, 59-67. https://doi.org/10.1016/j.jad.2022.07.004
References (8)
Papers cited by this study that are also in Blossom
Krupitsky, E. M., Burakov, A. M., Dunaevsky, I. V. et al. · Journal of Psychoactive Drugs (2007)
Luckenbaugh, D. A., Niciu, M. J., Ionescu, D. F. et al. · Journal of Affective Disorders (2014)
Mcinnes, L. A., Qian, J. J., Gargeya, R. S. et al. · Journal of Affective Disorders (2022)
Niciu, M. J., Shovestul, B. J., Jaso, B. A. et al. · Journal of Affective Disorders (2018)
Sanacora, G., Frye, M. A., McDonald, W. et al. · JAMA Psychiatry (2017)
Schenberg, E. E. · Frontiers in Pharmacology (2018)
Short, B., Fong, J., Galvez, V. et al. · Lancet Psychiatry (2017)
Weissman, C. R., Zeifman, R. J., Yu, D. et al. · Journal of Clinical Psychiatry (2022)
Cited By (5)
Papers in Blossom that reference this study
Aepfelbacher, J., Panny, B., Price, R. · Biological Psychiatry (2024)
Hietamies, T. M., Mcinnes, L. A., Klise, A. J. et al. · Journal of Affective Disorders (2023)
Mathai, D. S., Nayak, S., Yaden, D. B. et al. · Psychopharmacology (2023)
Meshkat, S., Haikazian, S., Di Vincenzo, J. D. et al. · Biological Psychiatry (2023)
Hassan, K., Struthers, W. M., Sankarabhotla, A. et al. · Frontiers in Psychiatry (2022)
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