Approval of esketamine for treatment-resistant depression – Author's reply
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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
US Food and Drug Administration approval of esketamine and brexanolone
Cristea, I. A., & Naudet, F. (2019) · The Lancet Psychiatry · doi:10.1016/s2215-0366(19)30292-5 · Cited by 98 · see citing works
Approval of esketamine for treatment-resistant depression
Singh, J. B., Daly, E. J., Mathews, M., Fedgchin, M., Popova, V., Hough, D., & Drevets, W. C. (2020) · The Lancet Psychiatry · doi:10.1016/s2215-0366(19)30533-4 · Cited by 46 · see citing works
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Research works printed but not linked: 1
- Singh JB, Daly EJ, Mathews M, et al. Approval of esketamine for treatmentresistant depression. Lancet Psychiatry 2020; 7: 232-34.
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Molecular mechanisms of the rapid-acting and long-lasting antidepressant actions of (R)-ketamine
Hashimoto, K. (2020) · Biochemical Pharmacology · doi:10.1016/j.bcp.2020.113935 · Cited by 239 · 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
“However, the sponsor did not explain why the FDA used the word “drives”, implying that its result was nonsignificant when this center was removed, nor why the FDA reported slightly different numbers of relapsed patients [8].”
Self-citation
- Authors
- Turner, E. H.
- Affiliations
- Oregon Health & Science University (US)
- Corresponding author
- Turner, Erick H
- ORCID
- Turner, Erick H
- Venue
- The Lancet Psychiatry
- Publisher
- Elsevier BV
- Published
- 2020-03
- Volume
- 7
- Issue
- 3
- Pages
- 236
- ISSN
- 2215-0366 (ISSN-L)
- OpenAlex
- W3007812988
- Cited by
- 2
- References
- 2
- Citations by year
- 2025: 1 · 2020: 1
- 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
- Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
- Keywords
- esketamine, treatment-resistant depression, selective serotonin reuptake inhibitors, clinician perspectives
- MeSH terms
- Depression, Female, Humans, Ketamine, Pregnancy, Suicide, Attempted, Depressive Disorder, Treatment-Resistant
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