European PsychiatryApril 1, 2021V. Rosello-Molina, F.J. Castells Pons, V. Avellon Juarez et al.
Introduction Esketamine had been rised as a potential treatment for Resistant Depression, becoming an alternative for the use of Electroconvulsive Therapy. In Spain since 2020, it has been applied for compassionate use but is not widely used. Although Esketamine is defined safe and effective in preliminary studies, there are common side effects which could reduce it use. Objectives Increasing...
Replicated international studies have underscored the human and societal costs associated with major depressive disorder. Despite the proven efficacy of monoamine-based antidepressants in major depression, the majority of treated individuals fail to achieve full syndromal and functional recovery with the index and subsequent pharmacological treatments. Ketamine and esketamine represent...
Major depressive disorder affects an estimate of 5% of the population with nearly 1‑third of patients failing to achieve remission with conventional pharmacological treatment. Esketamine, a novel rapid‑acting antidepressant, with a noncompetitive antagonism on N‑methyl‑D‑Aspartate receptor, have been recently approved by Food and Drug Administration (FDA) and European Medicines Agency (EMA) for...
This column reviews the development of intranasal esketamine with particular emphasis on the consistency of the clinical trial results. In the process, it illustrates methodological issues important in the approval process by an agency such as the United States Food and Drug Administration. Topics covered include the importance of study design, the nature of the comparator, and the prespecified...
Patients with treatment-resistant depression (TRD) treated with esketamine nasal spray commonly experience transient symptoms of dissociation. Manifestations of dissociation, such as feelings of detachment from the environment, can cause considerable anxiety for patients. Nonpharmacologic interventions may help clinicians to manage associated anxiety and confusion due to dissociation following...
The efficacy of ketamine in reducing suicidal ideation (SI) has been previously reported. We aimed to evaluate acute anti-SI effects of single-dose ketamine in different formulations/routes of administration by pooling results from randomized controlled trials (RCTs). A systematic search was conducted on Cochrane, Embase, Medline, and PubMed from inception to July 1st, 2020. Studies were...
Generic name: Esketamine hydrochloride Brand name: Spravato Formulation: 28mg in 0.2ml nasal spray solution Market Authorisation holder: Janssen-Cilag International NV Indication: Treatment resistant major depressive disorder in adults who have failed to respond to at least two different antidepressants during the current moderate to severe episode. To be used in combination with a selective...
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...