دورية أكاديمية
Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II).
| العنوان: | Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II). |
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| المؤلفون: | Ionescu DF; Department of Neuroscience, Janssen Research and Development, LLC, San Diego, CA., Fu DJ; Department of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ., Qiu X; Department of Statistics, Janssen Research and Development, LLC, Raritan, NJ., Lane R; Department of Statistics, Janssen Research and Development, LLC, Titusville, NJ., Lim P; Department of Statistics, Janssen Research and Development, LLC, Titusville, NJ., Kasper S; Center of Brain Research, Medical University of Vienna, Vienna, Austria., Hough D; Department of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ., Drevets WC; Department of Neuroscience, Janssen Research and Development, LLC, San Diego, CA., Manji H; Department of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ., Canuso CM; Department of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ. |
| المصدر: | The international journal of neuropsychopharmacology [Int J Neuropsychopharmacol] 2021 Jan 20; Vol. 24 (1), pp. 22-31. |
| نوع المنشور: | Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 9815893 Publication Model: Print Cited Medium: Internet ISSN: 1469-5111 (Electronic) Linking ISSN: 14611457 NLM ISO Abbreviation: Int J Neuropsychopharmacol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2015- : Oxford Oxford University Press Original Publication: Cambridge, [England] : Cambridge University Press, |
| مواضيع طبية MeSH: | Suicidal Ideation*, Antidepressive Agents/*pharmacology , Depressive Disorder, Major/*drug therapy , Ketamine/*pharmacology, Administration, Intranasal ; Adolescent ; Adult ; Antidepressive Agents/administration & dosage ; Double-Blind Method ; Female ; Humans ; Ketamine/administration & dosage ; Male ; Middle Aged ; Nasal Sprays ; Outcome Assessment, Health Care ; Patient Acuity ; Young Adult |
| مستخلص: | Background: Patients with major depressive disorder (MDD) having active suicidal ideation with intent require immediate treatment. Methods: This double-blind study (ASPIRE II) randomized adults (aged 18-64 years) with MDD having active suicidal ideation with intent to esketamine 84 mg or placebo nasal spray twice weekly for 4 weeks, given with comprehensive standard of care (hospitalization ≥5 days and newly initiated or optimized oral antidepressant[s]). Change from baseline to 24 hours post-first dose in Montgomery-Asberg Depression Rating Scale total score (primary efficacy endpoint) was analyzed using ANCOVA. Clinical Global Impression-Severity of Suicidality-revised (key secondary endpoint) was analyzed using ANCOVA on ranks of change. Results: Of 230 patients who were randomized (115 per arm), 227 received study drug and were included in efficacy/safety analyses; 184 (80.0%) completed double-blind treatment. Greater improvement in Montgomery-Asberg Depression Rating Scale total score was observed with esketamine (mean [SD]: -15.7 [11.56]) vs placebo (-12.4 [10.43]), each with standard of care, at 24 hours (least-squares mean difference [SE]: -3.9 [1.39], 95% CI: -6.60, -1.11; 2-sided P = .006). This was also noted at the earlier (4-hour) timepoint (least-squares mean difference -4.2, 95% CI: -6.38, -1.94). Patients in both treatment groups experienced rapid reduction in Clinical Global Impression-Severity of Suicidality-revised score; the between-group difference was not statistically significant. The most common adverse events among esketamine-treated patients were dizziness, dissociation, nausea, dysgeusia, somnolence, headache, and paresthesia. Conclusion: This study confirmed rapid and robust reduction of depressive symptoms with esketamine nasal spray in severely ill patients with MDD who have active suicidal ideation with intent. Trial Registration: Clinical Trials.gov identifier: NCT03097133. (© The Author(s) 2020. Published by Oxford University Press on behalf of CINP.) |
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| فهرسة مساهمة: | Keywords: Esketamine; depression; suicidal ideation; suicide risk |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03097133 |
| المشرفين على المادة: | 0 (Antidepressive Agents) 0 (Nasal Sprays) 50LFG02TXD (Esketamine) 690G0D6V8H (Ketamine) |
| تواريخ الأحداث: | Date Created: 20200830 Date Completed: 20220128 Latest Revision: 20220128 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC7816667 |
| DOI: | 10.1093/ijnp/pyaa068 |
| PMID: | 32861217 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1469-5111 |
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| DOI: | 10.1093/ijnp/pyaa068 |