Are we repeating mistakes of the past? A review of the evidence for esketamine

Horowitz, Mark

doi:10.1192/bjp.2020.89

Cited by 39 publications

(26 citation statements)

References 21 publications

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“…A placebo-controlled relapse prevention trial has also demonstrated prevention of depressive relapse after acute treatment (Daly et al, 2019). However, the clinical validity and significance of these short, and longer term data together with ongoing uncertainty around the issues of abuse potential is still a matter of pointed debate (Horowitz and Moncrieff, 2020; Kryst et al, 2020; Mahase, 2020; Schatzberg, 2014; Sial et al, 2020). The trials of esketamine showed a similar pattern of side effects to those of ketamine including transient post dose hypertension and dissociation in a proportion of subjects.…”

Section: Treatmentsmentioning

confidence: 99%

The 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders

Malhi

Bell

Bassett³

et al. 2020

Aust N Z J Psychiatry

346

365

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Objectives: To provide advice and guidance regarding the management of mood disorders, derived from scientific evidence and supplemented by expert clinical consensus to formulate s that maximise clinical utility. Methods: Articles and information sourced from search engines including PubMed, EMBASE, MEDLINE, PsycINFO and Google Scholar were supplemented by literature known to the mood disorders committee (e.g. books, book chapters and government reports) and from published depression and bipolar disorder guidelines. Relevant information was appraised and discussed in detail by members of the mood disorders committee, with a view to formulating and developing consensus-based recommendations and clinical guidance. The guidelines were subjected to rigorous consultation and external review involving: expert and clinical advisors, key stakeholders, professional bodies and specialist groups with interest in mood disorders. Results: The Royal Australian and New Zealand College of Psychiatrists mood disorders clinical practice guidelines 2020 (MDcpg2020) provide up-to-date guidance regarding the management of mood disorders that is informed by evidence and clinical experience. The guideline is intended for clinical use by psychiatrists, psychologists, primary care physicians and others with an interest in mental health care. Conclusion: The MDcpg2020 builds on the previous 2015 guidelines and maintains its joint focus on both depressive and bipolar disorders. It provides up-to-date recommendations and guidance within an evidence-based framework, supplemented by expert clinical consensus. Mood disorders committee: Gin S Malhi (Chair), Erica Bell, Darryl Bassett, Philip Boyce, Richard Bryant, Philip Hazell, Malcolm Hopwood, Bill Lyndon, Roger Mulder, Richard Porter, Ajeet B Singh and Greg Murray.

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Section: Treatmentsmentioning

confidence: 99%

The 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders

Malhi

Bell

Bassett³

et al. 2020

Aust N Z J Psychiatry

346

365

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“…Esketamine marketing authorization triggered a vivid debate and many concerns, mainly because of the lack of convincing evidence on its efficacy and safety, including the risk of misuse and suicide [3][4][5][6][7]. Currently, evidence on safety is almost entirely based on the development programs and approval trials [8][9][10][11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System

Gastaldon

Raschi

Kane

et al. 2020

Psychother Psychosom

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Introduction: Esketamine nasal spray received approval for treatment-resistant depression in March 2019. Objective: Using the FDA Adverse Event Reporting System (FAERS) database (March 2019–March 2020), we analysed esketamine-related adverse events (AEs) to detect and characterize relevant safety signals. Methods: We used the consolidated case/non-case approach to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for esketamine-related AEs with ≥4 counts. Comparisons between serious and non-serious AEs were performed using non-parametric tests. Results: The FAERS database contained 962 cases of esketamine-related AEs, with signals detected for several AEs, such as dissociation (ROR = 1,612.64, 95% CI = 1,354.63, 1,919.79; IC = 8.19, 95% CI = 7.96, 8.35), sedation (ROR = 238.46, 95% CI = 202.98, 280.15; IC = 7, 95% CI = 6.75, 7.18), feeling drunk (ROR = 96.17, 95% CI = 61.42, 150.57; IC = 4.84, 95% CI = 4.09, 5.36), suicidal ideation (ROR = 24.03, 95% CI = 18.72, 30.84; IC = 4.31, 95% CI = 3.9, 4.61), and completed suicide (ROR = 5.75, 95% CI = 3.18, 10.41; IC = 2.25, 95% CI = 1.23, 2.94). Signals for suicidal and self-injurious ideation, but not suicide attempt and completed suicide, remained when comparing esketamine to venlafaxine. Females and patients receiving antidepressant polypharmacy, co-medication with mood stabilizers, antipsychotics, benzodiazepines, or somatic medications were more likely to suffer from serious versus non-serious AEs (χ² = 125.29, p < 0.001, χ² = 9.08, p = 0.003, χ² = 8.14, p = 0.004, χ² = 19.48, p < 0.001, χ² = 25.62, p < 0.001, and χ² = 16.79, p < 0.001, respectively). Conclusions: Esketamine may carry a clear potential for serious AEs, which deserves urgent clarification by means of further prospective studies.

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“…In 2019, ( S )‐ketamine nasal spray of Johnson & Johnson was approved for treatment‐resistant patients with MDD although several concerns were addressed 28,29 . In contrast, ( R )‐ketamine did not cause psychotomimetic and dissociative side effects in healthy control subjects, whereas the same dose of ( S )‐ketamine produced these side effects in the healthy subjects 18 .…”

Section: Discussionmentioning

confidence: 99%

Decreased bone mineral density in ovariectomized mice is ameliorated after subsequent repeated intermittent administration of (R)‐ketamine, but not (S)‐ketamine

Fujita

Hashimoto

2020

Neuropsychopharm Rep

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Osteoporosis is the common chronic disease characterized by low bone mass and structural deterioration of bone tissue, leading to fragility of the bone. Depression is common in people with osteoporosis. A meta-analysis demonstrated that bone mineral density (BMD) in patients with depression is reduced compared to subjects without depression, 1 indicating depression as a risk factor for low BMD. 2-4 Furthermore, the use of antidepressants is associated with osteoporotic fracture in elderly peoples. 5,6 Importantly, the use of selective serotonin reuptake inhibitors (SSRIs) is associated with decreased BMD and increased fracture risk in humans. 7 Therefore, the development of the novel antidepressants which also have beneficial effects for osteoporosis is an unmet medical need.

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Are we repeating mistakes of the past? A review of the evidence for esketamine

Cited by 39 publications

References 21 publications

The 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders

The 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders

Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System

Decreased bone mineral density in ovariectomized mice is ameliorated after subsequent repeated intermittent administration of (R)‐ketamine, but not (S)‐ketamine

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