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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).
Ionescu, Dawn F; Fu, Dong-Jing; Qiu, Xin; Lane, Rosanne; Lim, Pilar; Kasper, Siegfried; Hough, David; Drevets, Wayne C; Manji, Husseini; Canuso, Carla M.
Afiliação
  • 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.
Int J Neuropsychopharmacol ; 24(1): 22-31, 2021 01 20.
Article em En | MEDLINE | ID: mdl-32861217
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transtorno Depressivo Maior / Ideação Suicida / Ketamina / Antidepressivos Tipo de estudo: Clinical_trials / Diagnostic_studies / Prognostic_studies Limite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transtorno Depressivo Maior / Ideação Suicida / Ketamina / Antidepressivos Tipo de estudo: Clinical_trials / Diagnostic_studies / Prognostic_studies Limite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2021 Tipo de documento: Article