Esketamine for treatment resistant depression: a trick of smoke and mirrors?
Chiara Gastaldon, D. Papola, G. Ostuzzi, Corrado Barbui
Epidemiology and Psychiatric Sciences 2020 DOI: 10.1017/s2045796019000751 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Commentary Peer reviewed |
|---|---|
| Intervention | Esketamine |
| Topics | Depression Esketamine Ketamine |
| Key points | The commentary critically examines the evidence on esketamine submitted to the FDA, with the aim of drawing implications for clinical practice, research, and regulatory science. It notes that esketamine is the S-enantiomer of ketamine, an approved anaesthetic associated with dissociation and occasionally hallucinations, and that ketamine remains unapproved for depression in the USA and other countries despite off-label use in severe depression. |
Abstract
Abstract In March 2019, the US Food and Drug Administration (FDA) approved a nasal spray formulation of esketamine for the treatment of resistant depression in adults. Esketamine is the S-enantiomer of ketamine, an FDA-approved anaesthetic, known to cause dissociation and, occasionally, hallucinations. While ketamine has not been approved for depression in the USA or in any other country, it has been used off-label in cases of severe depression. This commentary critically reviewed the evidence on esketamine submitted to the FDA, aiming to draw implications for clinical practice, research and regulatory science.
Citations in the library
Cited by 29
- Mechanisms of Ketamine and its Metabolites as Antidepressants Biochemical Pharmacology December 1, 2021
- Esketamine Treatment for Depression in Adults: A PRISMA Systematic Review and Meta-Analysis. American Journal of Psychiatry March 1, 2025
- Ketamine exerts its sustained antidepressant effects via cell-type-specific regulation of Kcnq2. Neuron May 1, 2022
- Efficacy and Safety of Intranasal Esketamine in Treatment-Resistant Depression in Adults: A Systematic Review Cureus August 21, 2021
- Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clinical Pharmacology & Therapeutics February 1, 2025
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Cites 8
- Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study American Journal of Psychiatry May 21, 2019
- Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression JAMA Psychiatry June 5, 2019
- Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression JAMA Psychiatry December 27, 2017
- Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) The International Journal of Neuropsychopharmacology July 9, 2019
- A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders JAMA Psychiatry March 1, 2017
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