Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression.
| Title: | Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression. |
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| Authors: | Williamson DJ; Field-Based Medical Affairs, Janssen Scientific Affairs, LLC, Titusville, New Jersey.; Drs Williamson and Daly and Mr Manera were affiliated with Janssen Scientific Affairs, LLC, at the time the trial was conducted.; Corresponding author: David J. Williamson, PhD, University of South Alabama College of Medicine, 2450 Old Shell Rd, Ste A, Mobile, AL 36607 (dr.williamson@comcast.net).; Gogate JP; Statistics and Decision Sciences, Janssen Research & Development, LLC, Titusville, New Jersey.; Kern Sliwa JK; Neuroscience Medical Information, Janssen Scientific Affairs, LLC, Titusville, New Jersey.; Manera LS; Janssen Medical Information, Janssen Scientific Affairs, LLC, Titusville, New Jersey.; Drs Williamson and Daly and Mr Manera were affiliated with Janssen Scientific Affairs, LLC, at the time the trial was conducted.; Preskorn SH; Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine, Wichita, Kansas.; Winokur A; Department of Psychiatry, UConn Health, Farmington, Connecticut.; Starr HL; Clinical Development, Janssen Scientific Affairs, LLC, Titusville, New Jersey.; Daly EJ; Field-Based Medical Affairs, Janssen Scientific Affairs, LLC, Titusville, New Jersey.; Drs Williamson and Daly and Mr Manera were affiliated with Janssen Scientific Affairs, LLC, at the time the trial was conducted. |
| Source: | The Journal of clinical psychiatry [J Clin Psychiatry] 2022 Sep 19; Vol. 83 (6). Date of Electronic Publication: 2022 Sep 19. |
| Publication Type: | Journal Article; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: Physicians Postgraduate Press Country of Publication: United States NLM ID: 7801243 Publication Model: Electronic Cited Medium: Internet ISSN: 1555-2101 (Electronic) Linking ISSN: 01606689 NLM ISO Abbreviation: J Clin Psychiatry Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Memphis, Tenn., Physicians Postgraduate Press. |
| MeSH Terms: | Major Depressive Disorder*/drug therapy ; Depressive Disorder, Treatment-Resistant*/drug therapy ; Ketamine*/administration & dosage ; Ketamine*/adverse effects; Antidepressive Agents/administration & dosage ; Antidepressive Agents/adverse effects ; Dizziness/chemically induced ; Nausea/chemically induced ; Vertigo/chemically induced ; Clinical Trials, Phase III as Topic ; Depression ; Humans ; Nasal Sprays |
| Abstract: | Objective: To describe the tolerability of esketamine nasal spray based on the adverse event profile observed during treatment sessions occurring early and later over the course of treatment.; Methods: In 2 long-term, phase 3 studies (NCT02493868, October 1, 2015-February 16, 2018; NCT02497287, September 30, 2015-October 28, 2017), patients with treatment-resistant major depressive disorder (per DSM-5) and nonresponse to ≥ 2 oral antidepressants received esketamine nasal spray (56 or 84 mg) twice weekly during a 4-week induction phase, weekly for weeks 5-8, and weekly or every 2 weeks thereafter as maintenance treatment, in conjunction with a new oral antidepressant. A post hoc analysis using descriptive statistics evaluated occurrence (incidence, frequency, severity) and recurrence (incidence and severity) of events of specific interest.; Results: In patients treated with esketamine nasal spray plus a newly initiated oral antidepressant (n = 928), spontaneously reported adverse events of dizziness, nausea, sedation, vertigo, and increased blood pressure were more likely to recur after the first week of treatment if they occurred more frequently (twice > once > none) during the first week. The same pattern was observed when these events were assessed by structured instruments. Incidences of dizziness, dissociation, increased blood pressure, nausea, vertigo, and sedation were highest in week 1 of treatment (20.6%, 16.7%, 4.3%, 14.0%, 12.1%, and 3.8%, respectively) and decreased thereafter. Initial occurrences and subsequent recurrences of events were mostly mild or moderate in severity.; Conclusions: Adverse events during treatment with esketamine nasal spray plus an oral antidepressant generally become less frequent with ongoing treatment, and the majority are mild or moderate in severity.; Trial Registration: ClinicalTrials.gov identifiers: NCT02493868; NCT02497287.; (© Copyright 2022 Physicians Postgraduate Press, Inc.) |
| Molecular Sequence: | ClinicalTrials.gov NCT02493868; NCT02497287; NCT02493868 |
| Substance Nomenclature: | 0 (Antidepressive Agents); 0 (Nasal Sprays); 50LFG02TXD (Esketamine); 690G0D6V8H (Ketamine) |
| Entry Date(s): | Date Created: 20220923 Date Completed: 20220928 Latest Revision: 20260127 |
| Update Code: | 20260130 |
| DOI: | 10.4088/JCP.21m14318 |
| PMID: | 36149841 |
| Database: | MEDLINE |
Journal Article; Research Support, Non-U.S. Gov't