Epidemiology and Psychiatric Sciences
2020
Chiara Gastaldon, D. Papola, G. Ostuzzi et al.
Abstract Maju et al. provided clarifications on important and controversial issues related to esketamine clinical trial data, in response to a vivid debate triggered by the marketing authorisation recently granted by this new medicine. In this commentary, we reply to their comments attempting to critically discuss the evidence base needed to obtain regulatory approval.
Therapeutic advances in drug safety
2020
Mohammed S Salahudeen, Cameron M Wright, Gregory M Peterson
This narrative review aims to provide an overview of the current literature on the pharmacology, safety, efficacy and tolerability of intranasal esketamine, the S-enantiomer of ketamine, for the treatment of treatment-resistant depression (TRD). A literature search using Medline, Embase, PsycINFO and Cochrane Central was conducted (January 2000 to July 2019). Product information and...
Drug Design, Development and Therapy
December 1, 2019
Jing Wang, Jie Huang, Shuang Yang et al.
214 citations
Purpose: To assess the pharmacokinetics and safety of pure S-ketamine (esketamine) in Chinese patients undergoing painless gastroscopy and evaluate the potential advantage of esketamine in clinical treatment compared with racemate ketamine hydrochloride injection. Patients and methods: A randomized, open-label, parallel-controlled, Phase I study was performed with 32 patients undergoing...
BMC Psychiatry
November 29, 2019
Sanne Y Smith-Apeldoorn, Jolien K E Veraart, Jeanine Kamphuis et al.
There is an urgent need to develop additional treatment strategies for patients with treatment-resistant depression (TRD). The rapid but short-lived antidepressant effects of intravenous (IV) ketamine as a racemic mixture have been shown repeatedly in this population, but there is still a paucity of data on the efficacy and safety of (a) different routes of administration, and (b) ketamine's...
Journal of Affective Disorders
November 14, 2019
Fernanda S. Correia-Melo, Gustavo C. Leal, Flávia Vieira et al.
188 citations
BACKGROUND Ketamine and its enantiomers have recently been highlighted as one of the most effective therapeutic options in refractory depression. However, racemic ketamine and esketamine have not been directly compared. The aim of this study is to assess the efficacy and safety of esketamine compared to ketamine in patients with treatment-resistant depression (TRD). METHODS This is a...
The Brown University Child & Adolescent Psychopharmacology Update
November 1, 2019
The recent approval of esketamine (Spravato) by the Food and Drug Administration (FDA) has raised many questions for psychiatrists who treat major depression, and even bigger questions for child psychiatrists. It's not approved for pediatric use by the FDA, but that doesn't mean it can't be prescribed off‐label.
Alcoholism & Drug Abuse Weekly
October 7, 2019
Alison Knopf
Like its predecessor intravenous ketamine, an anesthetic that has been used off‐label to treat depression, esketamine has shown great promise in treating a disease that can destroy quality of life and lead to suicide. The Food and Drug Administration (FDA) approved esketamine (Spravato) last spring for treating depression that is resistant to traditional treatments.
Journal of Addictions Nursing
October 1, 2019
William J Lorman
Treatment resistant depression is a common and burdensome condition with poor outcomes and few treatment options. Approximately one third of patients with major depressive disorder are treatment resistant to the current antidepressants. In addition, depression in patients with bipolar disorder is typically poorly responsive to antidepressants. And so, there is an unmet need for rapidly acting...
The Brown University Psychopharmacology Update
September 1, 2019
Esketamine nasal spray in combination with a newly initiated antidepressant was more effective than a new antidepressant plus placebo in reducing depressive symptoms in patients with treatment‐resistant depression, a Phase 3 study has found. Esketamine, the S‐enantiomer of ketamine, recently received Food and Drug Administration (FDA) approval for treatment‐resistant depression in adults. Study...
The International Journal of Neuropsychopharmacology
July 9, 2019
Maggie Fedgchin, Madhukar H. Trivedi, Ella Daly et al.
593 citations
BACKGROUND: About one-third of patients with depression fail to achieve remission despite treatment with multiple antidepressants and are considered to have treatment-resistant depression. METHODS: This Phase 3, double-blind, multicenter study enrolled adults with moderate-to-severe depression and nonresponse to ≥2 antidepressants in the current depression episode. Eligible patients (N = 346)...