Patients with major depressive disorder who do not respond to ≥2 different pharmacological treatments within the current depressive episode are considered to have treatment resistant depression (TRD). This analysis determined meaningful change thresholds (MCT) of the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) using anchor-based methods and...
OBJECTIVES: -methyl-d-aspartate (NMDA) glutamate receptor antagonist, is a novel, fast-acting option in this patient population. This manuscript provides expert guidance on the practicalities of using esketamine nasal spray. METHODS: A group of six European experts in major depressive disorder (MDD) and TRD, with clinical experience of treating patients with esketamine nasal spray, first...
Intranasal esketamine has been recently approved by both the American Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for treatment-resistant depression in adults and will be soon clinically available also in Italy. Esketamine is the (S) enantiomer of ketamine, a non-competitive N-Methyl-D-aspartate (NMDA) glutamate receptor antagonist, introduced in clinics as...
Background: Ketamine appears to have a therapeutic role in certain mental disorders, most notably depression. However, the comparative performance of different formulations of ketamine is less clear. Objectives: This study aimed to assess the comparative efficacy and tolerability of racemic and esketamine for the treatment of unipolar and bipolar major depression. Design: Systematic review and...
This post hoc analysis assessed the benefit-risk profile of esketamine nasal spray + oral antidepressant (AD) induction and maintenance treatment in patients with treatment-resistant depression (TRD). The Benefit-Risk Action Team framework was utilized to assess the benefit-risk profile using data from three induction studies and one maintenance study. Benefits were proportion of remitters or...
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...
Abstract Purpose To review the efficacy, safety, and place in therapy of intranasal esketamine, a treatment modality for treatment-resistant depression. Summary An electronic literature search of PubMed, MEDLINE, and the ClinicalTrials.gov and Food and Drug Administration (FDA) websites covering the period April 2015 through June 2020 was performed using the following search terms: esketamine,...
The Food and Drug Administration (FDA) announced Aug. 3 approval of Janssen Pharmaceutical's supplemental new drug application (sNDA) for the expanded use of SPRAVATO esketamine Clll nasal spray for the treatment of major depressive disorder (MDD) with acute suicidal ideation or behavior. SPRAVATO was initially approved by the FDA March 5, 2019, for the treatment of treatment‐resistant depression.
Abstract To elucidate the genetic underpinnings of the antidepressant efficacy of S-ketamine (esketamine) nasal spray in major depressive disorder (MDD), we performed a genome-wide association study (GWAS) in cohorts of European ancestry (n = 527). This analysis was followed by a polygenic risk score approach to test for associations between genetic loading for psychiatric conditions, symptom...