Approval of esketamine for treatment-resistant depression
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After the authors' pieces drew attention to the issue, the sponsor reported a sensitivity analysis in which the p-value changed from highly significant to barely significant.
“After our pieces drew attention to this issue, the sponsor reported a sensitivity analysis [14]: the p-value changed from highly significant to “barely significant” [8].”
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Cites
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Esketamine for Treatment-Resistant Depression — First FDA-Approved Antidepressant in a New Class
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Esketamine for treatment-resistant depression: seven concerns about efficacy and FDA approval
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Research works printed but not linked: 8
- Singh JB, Daly EJ, Mathews M, et al. Approval of esketamine for treatmentresistant depression. Lancet Psychiatry 2020; 7: 232-34.
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Approval of esketamine for treatment-resistant depression – Authors' reply
Naudet, F., & Cristea, I. A. (2020) · The Lancet Psychiatry · doi:10.1016/s2215-0366(20)30040-7 · Cited by 7 · see citing works
Naudet, F., Pellen, C., Fodor, L. A., Gastaldon, C., Barbui, C., Turner, E. H., Le Pabic, E., & Cristea, I. A. (2025) · BMC Medicine · doi:10.1186/s12916-025-04435-x · Cited by 6 · see citing works
“After our pieces drew attention to this issue, the sponsor reported a sensitivity analysis [14]: the p-value changed from highly significant to “barely significant” [8].”
Approval of esketamine for treatment-resistant depression – Author's reply
Turner, E. H. (2020) · The Lancet Psychiatry · doi:10.1016/s2215-0366(20)30044-4 · Cited by 2 · see citing works
- Authors
- Singh, J. B., Daly, E. J., Mathews, M., Fedgchin, M., Popova, V., Hough, D., & Drevets, W. C.
- Affiliations
- Janssen Scientific Affairs (United States) (US)
- Janssen (Belgium) (BE)
- Corresponding author
- Daly, Ella J
- Venue
- The Lancet Psychiatry
- Publisher
- Elsevier BV
- Published
- 2020-03
- Volume
- 7
- Issue
- 3
- Pages
- 232-235
- ISSN
- 2215-0366 (ISSN-L)
- OpenAlex
- W3008566999
- Semantic Scholar
- 92548e725bd260cca5bbdea25a64dd250ab64168
- Cited by
- 46
- References
- 17
- Citations by year
- 2026: 3 · 2025: 9 · 2024: 6 · 2023: 6 · 2022: 5 · 2021: 7 · 2020: 10
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Lancet Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Life Sciences › Neuroscience › Biological Psychiatry › Tryptophan and brain disorders
- Keywords
- esketamine, treatment-resistant depression, major depressive disorder, FDA approval, antidepressant non-response, flexible dosing, research design, antidepressant switching, NMDA receptor antagonists, ketamine derivatives, brexanolone, antidepressant efficacy, antidepressant safety, adverse events, relapse prevention
- MeSH terms
- Depression, Drug Combinations, Humans, Ketamine, Pregnanolone, United States, United States Food and Drug Administration, beta-Cyclodextrins, Depressive Disorder, Treatment-Resistant
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