Étiquette : Esketamine

Development of Ketamine Administration as a Treatment for Chronic PTSD, Abigail B. Collins et al., 2020

Development of Ketamine Administration as a Treatment for Chronic PTSD Abigail B. Collins, BS; Sarah B. Rutter, MA; and Adriana Feder, MD Psychiatric Annals, 2020, 50, (2), 68-76. doi : 10.3928/00485713-20200109-01   ABSTRACT Posttraumatic stress disorder (PTSD) is a highly prevalent, chronic, and dis-abling condition for which currently available pharmacotherapies are insuf-ficiently effective. Ketamine, which is a glutamate N-methyl-D-aspartate (NMDA) receptor antagonist, has emerged as a promising and rapid-act-ing novel treatment intervention for this disorder. Findings from a proof-of-concept, randomized, controlled cross-over study of single-dose intravenous ketamine administration (compared to single-dose midazolam) in patients with chronic PTSD suggest that ketamine is associated with rapid improvement in [...]

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FDA Okays New Indication for Esketamine Nasal Spray, Megan Brooks, Medscape – Aug 03, 2020.

FDA Okays New Indication for Esketamine Nasal Spray Megan Brooks Medscape - Aug 03, 2020. The US Food and Drug Administration (FDA) has approved the supplemental new drug application for esketamine nasal spray (Spravato, Janssen Pharmaceuticals) to treat depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior. The FDA approved esketamine nasal spray for treatment-resistant depression in March 2019, as reported by Medscape Medical News. The new indication is based on data from two identical phase 3 trials — ASPIRE I and ASPIRE II — which evaluated the efficacy and safety of the nasal spray in addition to a comprehensive standard of care [...]

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FDA’s Rapid Approval of Esketamine for Severe Depression Questioned, Pauline Anderson, Medscape, 2019

FDA's Rapid Approval of Esketamine for Severe Depression Questioned Pauline Anderson Medscape, November 13, 2019 https://www.medscape.com/viewarticle/921248 While some experts have hailed intranasal esketamine (Spravato, Janssen) as a "game changer" for treatment-resistant depression (TRD), others are concerned over the US Food and Drug Administration's (FDA) rapid approval of the drug. Dr Erick Turner In an editorial published online October 31 in Lancet Psychiatry, Erick H. Turner, MD, who sits on one of the FDA advisory committees that recommended approval of Spravato, said the drug did not meet standard criteria for FDA approval and that there was little evidence to support its safety and efficacy based on data from [...]

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EMA Panel Backs Esketamine Nasal Spray for Resistant Depression, Megan Brooks, Medscape Medical News, October 18, 2019

EMA Panel Backs Esketamine Nasal Spray for Resistant Depression Megan Brooks Medscape Medical News, October 18, 2019 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of esketamine nasal spray (Spravato, Janssen-Cilag) in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) for adults with treatment-resistant major depressive disorder (TRD). Patients are considered to have TRD if they have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode. Spravato will be available as a 28 mg nasal spray solution. The safety and [...]

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Psychiatric Practice Patterns and Barriers to the Adoption of Esketamine, Samuel T. Wilkinson et al., 2019

Psychiatric Practice Patterns and Barriers to the Adoption of Esketamine Samuel T. Wilkinson, David H. Howard,  Susan H. Busch JAMA Published online August 2, 2019 doi:10.1001/jama.2019.10728   Major depressive disorder (MDD) affects approximately 17.3 million adults in the United States,1 with a 12-month and lifetime prevalence of 10.4% and 20.6%, respectively.2 Conducting clinical trials and developing new treatments for depression can be difficult because of spontaneous recovery rates and placebo effects.3 In addition, many patients with chronic and refractory MDD do not experience clinical improvement even after several treatment courses. There is growing interest in the use of exercise and improved nutrition to treat depression,4 [...]

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Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study, Carla M. Canuso et al., 2018,

Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study Carla M. Canuso, M.D., Jaskaran B. Singh, M.D., Maggie Fedgchin, Pharm.D., Larry Alphs, M.D., Ph.D., Rosanne Lane, M.A.S., Pilar Lim, Ph.D., Christine Pinter, M.S., David Hough, M.D., Gerard Sanacora, M.D., Ph.D., Husseini Manji, M.D., Wayne C. Drevets, M.D. American Journal of Psychiatry, 2018, 175, 620–630 doi: 10.1176/appi.ajp.2018.17060720   Objective : The authors compared the efficacy of standardof- care treatment plus intranasal esketamine or placebo for rapid reduction of symptoms of major depression, including suicidality, among [...]

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Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression. A Randomized Clinical Trial, Ella J. Daly et al., 2019

Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression. A Randomized Clinical Trial Ella J. Daly, MD; Madhukar H. Trivedi, MD; Adam Janik, MD; Honglan Li, MD, PhD; Yun Zhang, PhD; Xiang Li, PhD; Rosanne Lane, MAS; Pilar Lim, PhD; Anna R. Duca, BSN; David Hough, MD; Michael E. Thase, MD; John Zajecka, MD; Andrew Winokur,MD, PhD; Ilona Divacka, MBA, MD; Andrea Fagiolini, MD; Wiesław J. Cubała, MD, PhD; István Bitter,MD, PhD; Pierre Blier,MD, PhD; Richard C. Shelton, MD; Patricio Molero,MD, PhD; Husseini Manji, MD;Wayne C. Drevets, MD; Jaskaran B. Singh, MD JAMA Psychiatry, [...]

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Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study, Vanina Popova et al., 2019

Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study Vanina Popova, M.D., Ella J. Daly, M.D., Madhukar Trivedi, M.D., Kimberly Cooper, M.S., Rosanne Lane, M.A.S., Pilar Lim, Ph.D., Christine Mazzucco, M.Sc., David Hough, M.D., Michael E. Thase, M.D., Richard C. Shelton, M.D., Patricio Molero, M.D., Ph.D., Eduard Vieta, M.D., Ph.D., Malek Bajbouj, M.D., Husseini Manji, M.D., Wayne C. Drevets, M.D., Jaskaran B. Singh, M.D. American Journal of Psychiatry in Advance, 2019 ajp.psychiatryonline.org doi: 10.1176/appi.ajp.2019.19020172   Objective : About one-third of patients with depression fail to achieve remission despite treatment with multiple [...]

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