The correlation of Esketamine with specific adverse events: a deep dive into the FAERS database

European Archives of Psychiatry and Clinical Neuroscience, Journal Year: 2023, Volume and Issue: unknown

Published: Dec. 16, 2023

Language: Английский

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The Role of Ketamine in the Treatment of Bipolar Depression: A Scoping Review

Brain Sciences, Journal Year: 2023, Volume and Issue: 13(6), P. 909 - 909

Published: June 4, 2023

Bipolar depression remains a clinical challenge with quarter of patients failing to respond initial conventional treatments. Although ketamine has been extensively studied in unipolar depression, its role bipolar disorder inconclusive. The aim our scoping review was comprehensively synthesize the current literature around use depression. A total 10 studies (5 randomized controlled trials and 5 open label studies) were selected. preliminary evidence, albeit weak, suggests that is promising treatment calls for further interest from research community. Overall, appeared be tolerable minimal risk manic/hypomanic switching showed some effectiveness across parameters suicidality. Moreover, potential agent treatment-resistant data extracted extant real-world studies. Future are needed identify ketamine’s acute maintenance phases future researchers should study recurrence prevention anti-suicidal effects

Language: Английский

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Predicting outcome with Intranasal Esketamine treatment: A machine-learning, three-month study in Treatment-Resistant Depression (ESK-LEARNING)

Psychiatry Research, Journal Year: 2023, Volume and Issue: 327, P. 115378 - 115378

Published: July 29, 2023

Treatment-resistant depression (TRD) represents a severe clinical condition with high social and economic costs. Esketamine Nasal Spray (ESK-NS) has recently been approved for TRD by EMA FDA, but data about predictors of response are still lacking. Thus, tool that can predict the individual patients' probability to ESK-NS is needed. This study investigates sociodemographic features predicting responses in patients using machine learning techniques. In retrospective, multicentric, real-world involving 149 subjects, psychometric (Montgomery-Asberg-Depression-Rating-Scale/MADRS, Brief-Psychiatric-Rating-Scale/BPRS, Hamilton-Anxiety-Rating-Scale/HAM-A, Hamilton-Depression-Rating-Scale/HAMD-17) were collected at baseline one month/T1 three months/T2 post-treatment initiation. We trained different random forest classifiers, able accuracies 68.53% T1 66.26% T2 remission 68.60% accuracy. Features like anhedonia, anxious distress, mixed symptoms as well bipolarity found positively remission. At same time, benzodiazepine usage severity linked delayed responses. Despite some limitations (i.e., retrospective study, lack biomarkers, correct interrater-reliability across centers), these findings suggest potential personalized intervention TRD.

Language: Английский

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Investigating the Effectiveness and Tolerability of Intranasal Esketamine Among Older Adults With Treatment-Resistant Depression (TRD): A Post-hoc Analysis from the REAL-ESK Study Group

American Journal of Geriatric Psychiatry, Journal Year: 2023, Volume and Issue: 31(12), P. 1032 - 1041

Published: July 8, 2023

IntroductionTreatment-resistant depression (TRD) is a serious and debilitating psychiatric disorder that frequently affects older patients. Esketamine nasal spray (ESK-NS) has recently been approved as treatment for TRD, with multiple studies establishing its efficacy tolerability. However, the real-world effectiveness, tolerability, safety of this in adults still unclear.ObjectivesTo evaluate tolerability ESK-NS subjects TRD.MethodsThis post-hoc analysis REAL-ESK study, multicenter, retrospective, observational study. Participants here selected were 65 years or at baseline. The Montgomery-Åsberg Depression Rating Scale (MADRS) Hamilton Anxiety (HAM-A) used to assess depressive anxiety symptoms, respectively. Data collected three time points: baseline, one month after start (T1), months (T2).ResultsThe sample included TRD (n=30). MADRS HAM-A values decreased significantly T1 (T0vsT1: pholm<0.001, Cohen's d=0.840) T2 follow-ups (T0vsT2: d=1.419). At T2, 53.3% responders (MADRS score reduced ≥ 50%), while 33.33% remission (MADRS<10). ESK-NS-related adverse effects order frequency dizziness (50%), followed by dissociation (33.3%), sedation (30%), hypertension (13.33%). Six out 30 participants (20%) discontinued treatment.ConclusionsOur findings provide preliminary evidence effectiveness highly presentation. Furthermore, we observe high levels treatment-emergent events, which, majority instances, did not require suspension.

Language: Английский

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The rapid antidepressant effectiveness of repeated dose of intravenous ketamine and intranasal esketamine: A post-hoc analysis of pooled real-world data

Journal of Affective Disorders, Journal Year: 2023, Volume and Issue: 348, P. 314 - 322

Published: Dec. 23, 2023

Language: Английский

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Efficacy and safety of perioperative application of esketamine on postpartum depression: A meta-analysis of randomized controlled studies

Psychiatry Research, Journal Year: 2024, Volume and Issue: 333, P. 115765 - 115765

Published: Feb. 2, 2024

Language: Английский

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A comparison between psilocybin and esketamine in treatment-resistant depression using number needed to treat (NNT): A systematic review

Journal of Affective Disorders, Journal Year: 2024, Volume and Issue: 350, P. 698 - 705

Published: Jan. 21, 2024

Language: Английский

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Anhedonia in bipolar depression treated with ketamine

Bipolar Disorders, Journal Year: 2024, Volume and Issue: 26(4), P. 356 - 363

Published: Feb. 4, 2024

Abstract Background Bipolar depression is the major cause of morbidity in patients with bipolar disorder. It affects psychosocial functioning and markedly impairs occupational productivity. Anhedonia one most debilitating symptoms contributing to treatment resistance. correlates suicidality, low quality life, social withdrawal, poor response. Currently, there no approved specifically targeting anhedonia. Emerging evidence suggests that ketamine possesses anti‐anhedonic properties individuals depression. Objectives The aim this naturalistic open‐label study was investigate effect add‐on on anhedonia resistant Methods Our main interest change patient‐reported (Snaith‐Hamilton Pleasure Scale) rater‐based measure (Montgomery–Åsberg Depression Rating Scale‐anhedonia subscale). secondary analyze score three Inventory Depressive Symptomatology‐Self Report (IDS‐SR) domains: mood/cognition, anxiety/somatic, sleep. Patients underwent assessments at several time points, including baseline, after third, fifth, seventh infusions. Additionally, a follow‐up assessment conducted 1 week following final administration. Results We found improvement according both measures. IDS‐SR domains prominent anxiety/somatic factor mood/cognition factor, sleep not observed. No serious adverse events occurred. Conclusion Add‐on seems be good choice for also showed reducing anxiety group patients. Considering unmet needs detrimental anxiety, more studies are needed

Language: Английский

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Comparing fast-acting interventions for treatment-resistant depression: An explorative study of accelerated HF-rTMS versus intranasal esketamine

Brain stimulation, Journal Year: 2023, Volume and Issue: 16(4), P. 1041 - 1043

Published: June 17, 2023

Treatment-resistant depression (TRD), the non-response to two different antidepressant classes during a major depressive episode, is severe clinical condition in almost 30% of depressed patients, carrying substantial direct and indirect financial burdens on healthcare system [[1]Zhdanava M. et al.The prevalence national burden treatment-resistant disorder United States.J Clin Psychiatry. Mar. 2021; 82https://doi.org/10.4088/JCP.20m13699Crossref PubMed Google Scholar]. Accelerated ArTMS (arTMS) protocols are novel approaches that exert comparable efficacy without significantly compromising safety tolerability associated with standard rTMS regimen [[2]Sonmez A.I. al.Accelerated TMS for Depression: systematic review meta-analysis.Psychiatr Res. 2019; 273: 770-781https://doi.org/10.1016/j.psychres.2018.12.041Crossref Scopus (90) Scholar,[3]Fitzgerald P.B. Hoy K.E. Elliot D. Susan McQueen R.N. Wambeek L.E. Daskalakis Z.J. repetitive transcranial magnetic stimulation treatment depression.Neuropsychopharmacology. Jun. 2018; 43: 1565-1572https://doi.org/10.1038/s41386-018-0009-9Crossref (73) arTMS also ensures potential rapid action, observable within initial post-treatment weeks [[4]Cole E.J. al.Stanford accelerated intelligent neuromodulation therapy depression.Am J Psychiatr. Aug. 2020; 177: 716-726https://doi.org/10.1176/appi.ajp.2019.19070720Crossref (184) This qualifies as therapeutic intervention TRD, glutamatergic modulators like intranasal esketamine (ESK-NS), an N-methyl-d-aspartate (NMDA) receptor antagonist [[5]d'Andrea G. Pettorruso Di Lorenzo Mancusi McIntyre R.S. Martinotti Rethinking ketamine action: they antidepressants mood-stabilizing properties?.Eur Neuropsychopharmacol. 2023; 70: 49-55https://doi.org/10.1016/j.euroneuro.2023.02.010Crossref (1) Scholar], approved first agent TRD by FDA EMA [[6]Martinotti al.Real-world experience use manage depression: multicentric study effectiveness (REAL-ESK study).J Affect Disord. Sep. 2022; 319: 646-654https://doi.org/10.1016/j.jad.2022.09.043Crossref (7) A comparison between these currently missing. Hence, this aimed compare (a) speed action (b) ESK-NS treating TRD. In multicentric, observational, retrospective study, we studied 59 patients (women/men, n = 32/n 27; age, 54.61 ± 11.32) who consecutively underwent either one-week, high-frequency protocol (ReModula: four daily sessions HF-rTMS over left DLPFC five consecutive days) or three-month (biweekly administrations month; weekly second month: bimonthly third month). Study design administration procedures fully detailed supplementary materials. Treatment assignment (arTMS: 30; ESK-NS: 29) was determined based clinician's judgment. The severity assessed total score Montgomery–Åsberg Depression Rating Scale (MADRS) at baseline (T0), one month (T1), three months (T2) after initiation treatment. Sociodemographic characteristics did not differ groups T0 (see materials), except longer duration current episode among those treated (months, 19.57 13.42 vs. 12.03 9.47; t57 2.484, p 0.016). rm-ANCOVA (within-factor: "time"; between-factors: "gender", "protocol"; covariate: number failed trials episode) showed significant "time" × "protocol" interaction effect (F2.104 3.814, 0.025, ηp2 0.068) MADRS score, Mauchly's test sphericity (W 0.893, χ22 5.794, 0.055). As shown Fig. 1A, scores groups:a)did (p 0.307);b)decreased separately T1 (arTMS, T1: < 0.001, d 1.709; ESK-NS, 1.361) T2 T2: 1.822; arTMS, 0.989, 0.218; 2.338; 1.042);c)significantly differed 0.048), higher decrease (d 0.864) group, but 1.000). upper panels 1B, response rates (RRs) (≥50% score) were than (respectively, 15/50% 5/17.24%: χ12 7.062, 0.008), (n 18/60% 20/68.97%: 0.517, 0.472). remission (MADRS <10) (T1, 5/16.67% 1/3.45%: 2.820, 0.093; T2, 12/40% 10/34.48%: 0.192, 0.661), depicted lower 1B. Regarding tolerability, eight (26.66%) from group 24 (82.75%) reported treatment-related side effects (trSEs). most frequent trSEs transient post-stimulation headache (13.33%) scalp discomfort site (10%). Additionally, participant encountered mid-episode agitation throughout session, which didn't require any specific intervention. prevalent were: temporary sedation (55.17%), dissociative symptoms (34.5%), short-lived hypertension (10%), brief (6.89%). Our findings revealed had more effect, yielding RRs one-month follow-up ESK-NS. aligns previous research, suggesting faster can shorten duration, maintaining Simultaneously, potentially lead swifter Besides, consistent existing literature, reports 60% 62.06% Scholar,[7]Miron J.-P. Jodoin V.D. Lespérance P. Blumberger D.M. Repetitive disorder: basic principles future directions.Ther. Adv. Psychopharmacol. 1120451253211042696https://doi.org/10.1177/20451253211042696Crossref terms both treatments found be safe, minor trSEs. Notably, demonstrate incidence, offering tolerable option. However, incidence real-world settings Interestingly, neither induced manic switches, confirming their Scholar,[8]Miuli A. al.Hypomanic/manic switch mood disorders: meta-analysis.World 11: 477-490https://doi.org/10.5498/wjp.v11.i8.477Crossref Scholar,[9]Martinotti al.Treating bipolar esketamine: data naturalistic versus unipolar depression.Bipolar n/ahttps://doi.org/10.1111/bdi.13296Crossref (3) Several limitations should considered. Firstly, nature allow randomization blinded assessors. study's strength since it representative conditions, unlike RCTs often involve only pre-screened subjects. Secondly, limited sample size highlights need extensive cohort studies validation. explorative research replicated, especially through randomized prospective studies. work supported Italian Ministry Health (Ricerca Finalizzata, Young Researchers grant, GR-2019-12370173). "Departments Excellence 2018–2022" initiative Education, University Research Department Neuroscience, Imaging Clinical Sciences (DNISC) Chieti-Pescara.

Language: Английский

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Ketamine and the Disinhibition Hypothesis: Neurotrophic Factor-Mediated Treatment of Depression

Pharmaceuticals, Journal Year: 2023, Volume and Issue: 16(5), P. 742 - 742

Published: May 12, 2023

Ketamine is a promising alternative to traditional pharmacotherapies for major depressive disorder, treatment-resistant depression, and other psychiatric conditions that heavily contribute the global disease burden. In contrast current standard of care medications these disorders, ketamine offers rapid onset, enduring clinical efficacy, unique therapeutic potential use in acute, emergencies. This narrative presents an framework understanding as mounting evidence supports neuronal atrophy synaptic disconnection theory, rather than prevailing monoamine depletion hypothesis. this context, we describe ketamine, its enantiomers, various metabolites range mechanistic actions through multiple converging pathways, including N-methyl-D-aspartate receptor (NMDAR) inhibition enhancement glutamatergic signaling. We disinhibition hypothesis, which posits ketamine’s pharmacological action ultimately results excitatory cortical disinhibition, causing release neurotrophic factors, most important brain-derived factor (BDNF). BDNF-mediated signaling along with vascular endothelial growth (VEGF) insulin-like 1 (IGF-1) subsequently give rise repair neuro-structural abnormalities patients disorders. Ketamine’s efficacious amelioration depression revolutionizing treatment opening up fresh vistas underlying causes mental illness.

Language: Английский

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