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ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depression

التفاصيل البيبلوغرافية
العنوان: ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depression
المؤلفون: S. Ludovic, M.A. Codet, M. Rotharmel, P. De Maricourt, J. Boursicot, E. Gaudre Wattinne
المصدر: European Psychiatry, Vol 65, Pp S270-S271 (2022)
بيانات النشر: Cambridge University Press, 2022.
سنة النشر: 2022
المجموعة: LCC:Psychiatry
مصطلحات موضوعية: esketamine, Treatment Resistant Depression, retrospective study, Real World Evidence, Psychiatry, RC435-571
الوصف: Introduction Esketamine nasal spray has been developed to treat adults with treatment resistant depression. On Dec.2019, EMA granted a market access approval in this indication. Objectives ESKALE is a descriptive study of treatment resistant depression patients treated with esketamine in France. Methods Observational retrospective study. 157 patients are included in 3 cohorts depending on their treatment initiation date. This abstract presents the second interim results of patients treated with esketamine and whom data collection ranges from Oct.2019 and Sept.2021. Results 66.7% of patients were females. Average age was 49 years old with 26 patients > 65 years old. Duration of the current depressive episode was 26.0 months (mean). 48.8% of patient have > 1 suicide attempt during whole life. At esketamine initiation, 78.2% patients were clinically perceived to have severe depression with a MADRS score of 32.4 (median) and a PHQ9 score of 19.5 (median). For the overall sample, esketamine was prescribed in median as a 3rd line and for 40.5% of patients after neurostimulation. The majority of the patient started esketamine at 28 mg or 56 mg and increased the dose to 84 mg. After 4 months of treatment, clinical benefits are the following: decrease of MADRS total score -16.5 points (median) corresponding to 58% of responders and a PHQ9 total score decrease of -8.6 points (median). No new safety signal detected. Conclusions This second interim analysis describes patients’ profiles and clinical evolution over a longer period and a broader population than the first interim analysis. The conditions of use are consistent with the ones approved by health authorities. Disclosure I (Marie-Alix Codet) works as a full employee at Janssen Cilag
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 0924-9338
1778-3585
Relation: https://www.cambridge.org/core/product/identifier/S0924933822006939/type/journal_article; https://doaj.org/toc/0924-9338; https://doaj.org/toc/1778-3585
DOI: 10.1192/j.eurpsy.2022.693
URL الوصول: https://doaj.org/article/291ca810de574584b12e103fe6e11184
رقم الأكسشن: edsdoj.291ca810de574584b12e103fe6e11184
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:09249338
17783585
DOI:10.1192/j.eurpsy.2022.693