Spravato (esketamine intranasal) / J&J - LARVOL DELTA

Efficacy and Safety of Intranasal Esketamine in Treatment-Resistant Depression with Comorbid Autism Spectrum Disorder: Three Case Reports. (PubMed, Clin Pract) - "Intranasal esketamine showed a favorable efficacy and safety in these three cases of TRD in comorbidity with ASD (at six months: total remission = 66.66%, partial remission = 33.33%, inefficacy = 0%, drop-out = 0, severe adverse events = 0). Besides improvements in depressive symptoms, esketamine was associated with a constant decrease in suicidal thoughts. A case series is unfit to form statistical conclusions; preliminary data warrant further investigation in randomized controlled studies to validate the therapeutic potential of esketamine in this population."

Journal • Autism Spectrum Disorder • CNS Disorders • Depression • Genetic Disorders • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

Cognitive Effects of Esketamine in Treatment-Resistant Depression: A Systematic Review. (PubMed, J Clin Psychopharmacol) - "Current evidence, albeit limited, suggests that esketamine appears to be cognitively safe in adults with treatment-resistant depression and may confer selective improvements, particularly in attention and processing speed, with more variable benefits in memory and executive functioning over sustained treatment. These effects may support functional recovery and complement esketamine's antidepressant action. Further research using harmonized cognitive batteries, larger samples, and longer follow-up periods is needed to better characterize cognitive trajectories and their relevance for personalized treatment strategies."

Journal • Alzheimer's Disease • Anesthesia • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients (clinicaltrials.gov) - P4 | N=160 | Not yet recruiting | Sponsor: Peking University First Hospital

New P4 trial • Pain • Pediatrics

Commentary on "Long-term treatment with esketamine nasal spray in patients with treatment resistant depression: Results from the ESCAPE-LTE study". (PubMed, Eur Neuropsychopharmacol) - No abstract available

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Intranasal esketamine: real-world clinical practice in treatment-resistant depression and factors associated with treatment response. (PubMed, BMC Psychiatry) - No abstract available

Journal • Real-world evidence • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

KF2024#1-trial: Esketamine Interaction Study (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Helsinki University Central Hospital | Not yet recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Apr 2025 | Trial primary completion date: Dec 2025 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date

Evaluation of Current Evidence on the Efficacy of Esketamine in Treating Substance-Use Disorders in Patients With Treatment-Resistant Depression (TRD): A Narrative Review. (PubMed, Cureus) - "In rodent models, esketamine significantly inhibited cocaine-seeking after various abstinence conditions, and clinical data point to its potential role in treating alcohol misuse. In conclusion, esketamine holds potential as a dual-action therapeutic in patients with TRD and comorbid addiction; however, further large-scale studies are needed to explore its therapeutic magnitude, duration of benefit, safety, and effects on substance use-related outcomes."

Journal • Review • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Tobacco Addiction

Effectiveness and factors associated with esketamine response during the 4-week induction period for treatment-resistant depression: post-hoc analysis of the real-world ESKALE study. (PubMed, J Psychiatr Res) - "This post-hoc analysis provides further evidence of a rapid response after ESK initiation in patients with TRD and that early dissociation may play a role in treatment response. However, future research is needed to investigate prognostic factors associated with ESK response in patients with TRD."

Journal • Real-world evidence • Retrospective data • CNS Disorders • Depression • Mood Disorders • Psychiatry

Fast-acting approaches for treatment-resistant depression: real-world comparative effectiveness of Intranasal Esketamine versus accelerated rTMS. (PubMed, Int J Psychiatry Clin Pract) - "aTMS showed a stronger early antidepressant effect, but its advantage over esketamine progressively diminished and was no longer evident at six months. Prospective, well-powered comparative trials are required to validate these findings."

HEOR • Journal • Real-world evidence • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

High-flow versus standard nasal cannula oxygenation for post-procedural quality of recovery in older adults undergoing sedated ERCP: protocol for a randomized controlled trial. (PubMed, Ann Med) - P=N/A | "Following esketamine 0.25 mg/kg and propofol target-controlled infusion (plasma concentration 2.5 µg/mL), patients will be randomly allocated (1:1) to receive either HFNC oxygenation (40 L/min, 100% O2, 37 °C) or standard nasal cannula oxygenation (5 L/min)...The findings will inform evidence-based respiratory support strategies during ERCP in older adults. Chinese Clinical Trial Registry (Identifier: ChiCTR2500105743)."

Clinical protocol • Journal • Anesthesia • Immunology • Inflammation • Systemic Inflammatory Response Syndrome

Ketamine pharmacotherapy for major depressive disorder: A narrative review. (PubMed, Prog Neuropsychopharmacol Biol Psychiatry) - "It then reviews the pharmacokinetic properties of both intravenous (IV) ketamine and intranasal (IN) esketamine, including their dosing, bioavailability, onset of action, elimination, and other clinical considerations...Next, it summarizes the efficacy and effectiveness of IV and IN ketamine, which have demonstrated mixed-to-positive antidepressant effects in a limited-to-moderate number of outcome studies in both randomized, controlled trials and real-world, open-label studies; also, comparative outcome studies have demonstrated non-inferiority to other established treatments and combination studies have shown mixed-to-positive gains when combined with those established treatments, including electroconvulsive therapy, pharmacotherapy, transcranial magnetic therapy, and psychotherapy. Finally, this review provides predictions and recommendations for future research, including the development and enhancement of novel therapeutics, identification of predictive markers to..."

Journal • Review • Anesthesia • Cardiovascular • CNS Disorders • Depression • Hypertension • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

COMPARATIVE MEASUREMENT OF ESKETAMINE RESPONSE IN TREATMENT-RESISTANT DEPRESSION USING PHQ-9 AND DSM-5 CRITERIA (ISPOR 2026) - "These findings support integrating the DSM-XC alongside the PHQ-9 to evaluate Spravato treatment outcomes. Comorbid conditions were common which underscored the importance of multidimensional assessment in care. Future research with larger samples and longer follow-up is required to validate these findings and refine measurement-based care models for esketamine treatment."

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • General Anxiety Disorder • Major Depressive Disorder • Mood Disorders • Psychiatry

Non-inferiority, comparative effectiveness study of intravenous ketamine v. intranasal esketamine for treatment-resistant depression: The EQUIVALENCE trial protocol. (PubMed, Contemp Clin Trials) - "We will also examine whether TRD with anxious distress responds differentially to one treatment or the other and the role that patient preference plays in outcomes. Results of the EQUIVALENCE study will have important implications for patient choice, health insurance coverage policies, and clinical care for TRD."

Head-to-Head • HEOR • Journal • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry

Efficacy and Safety of Dexmedetomidine-Esketamine Versus Dexmedetomidine Alone as Premedication for Pediatric Anesthesia Induction: A Systematic Review, Meta-Analysis, and Trial Sequential Analysis. (PubMed, Paediatr Anaesth) - "The intranasal DEX-ESK combination was associated with improved outcomes compared with DEX monotherapy for pediatric premedication including reductions in ED incidence, a modest acceleration in sedation onset, improved mask acceptance, and slightly shorter PACU length of stay, without an increased risk of adverse events. This combination may represent a feasible and safe premedication option for pediatric patients."

Journal • Retrospective data • Review • Anesthesia • Cardiovascular • CNS Disorders • Hypotension • Pain • Pediatrics

CESAR: Comparison of esketamine with an antidepressant versus aripiprazole with an antidepressant, in the refractory major depression disorder in elderly patients (clinicaltrialsregister.eu) - P2/3 | N=220 | Recruiting | Sponsor: Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Geriatric Disorders • Major Depressive Disorder • Mood Disorders • Psychiatry

Safety of Intranasal Esketamine Administration in Brugada Syndrome: Two Clinical Case Reports. (PubMed, J Clin Psychopharmacol) - No abstract available

Journal • Cardiovascular • Genetic Disorders

54135419SUI3003: A study for adolescents who are depressed and thinking of suicide (clinicaltrialsregister.eu) - P2/3 | N=96 | Not yet recruiting | Sponsor: Janssen Cilag International

New P2/3 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

Effective doses of esketamine oral or esketamine intranasal for the prevention of preoperative anxiety in pediatric patients: A randomized double-blind dose-finding trial. (PubMed, Medicine (Baltimore)) - "This study demonstrates the efficacy of single-dose esketamine regimens, administered orally (ED95: 8.2125 mg/kg; 95% CI: 7.4250-8.4597 mg/kg) and intranasally (ED95: 2.1770 mg/kg; 95% CI: 2.0952-2.1958 mg/kg), in mitigating preoperative anxiety within a pediatric population. These findings highlight the safety and efficacy of esketamine for this patient group."

Journal • Anesthesia • CNS Disorders • Pediatrics • Psychiatry

Progress, potential and pitfalls of ketamine as a treatment for Depression and related disorders. (PubMed, Expert Opin Pharmacother) - "Evidence supporting the use of intravenous ketamine and intranasal esketamine for depression has dramatically increased with a large number of clinical trials and real-world effectiveness studies supporting antidepressant effects...Further research is needed to optimize protocols, such as combining ketamine with other interventions. Functional unblinding, expectancy related bias and treatment costs remain challenges for the field."

Journal • Review • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Obsessive-Compulsive Disorder • Personality Disorder • Post-traumatic Stress Disorder • Psychiatry

Long-term treatment with esketamine nasal spray in patients with treatment resistant depression: Results from the ESCAPE-LTE study. (PubMed, Eur Neuropsychopharmacol) - P3, P4 | "In the subgroup with remission in ESCAPE-TRD, 79.2% did not relapse or discontinue treatment throughout ESCAPE-LTE; the overall relapse rate for patients achieving remission across both studies was 6.9%. The vast majority of patients with TRD who achieved remission with esketamine NS did not relapse over 136 weeks of treatment; no new safety concerns were identified, and the safety profile was consistent with short-term studies."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Hospital Universitari Vall d'Hebron Research Institute | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Integrating Psychiatric, Psychotherapeutic, and Nursing Care in Intranasal Esketamine for Treatment-Resistant Depression. (PubMed, J Clin Med) - " Intranasal esketamine represents not only a pharmacological innovation but also a treatment that necessitates an integrated multidisciplinary approach. A structured phase-based multidisciplinary approach may support safer, more acceptable delivery of intranasal esketamine and potentially improve retention and patient experience; however, prospective implementation and comparative studies are needed to evaluate clinical effectiveness, feasibility, and cost-effectiveness."

Journal • Review • CNS Disorders • Depression • Mood Disorders • Psychiatry

Narrative Experiences of Esketamine-Induced Dissociation in Patients with Treatment-Resistant Depression: A Qualitative Exploratory Study. (PubMed, Brain Sci) - "Rather, they suggest that dissociation functions as a transitional subjective state, the clinical relevance of which depends on anticipation, framing, monitoring, and integration. These results support the use of structured psychoeducation, in-session support, and post-session integration within real-world esketamine programs."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Hospital Universitari Vall d'Hebron Research Institute

New trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Ketamine as a Mental Health Treatment. (PubMed, Am J Nurs) - "Additionally, the S-ketamine enantiomer of ketamine, esketamine (marketed as Spravato), received approval for treatment-resistant depression in 2019...The current ketamine landscape has created a perfect storm in which the regulation of ketamine's use in mental health treatment remains fragmented, the evidence is constantly evolving, and a vulnerable population of individuals who are struggling with treatment-resistant mental health symptoms are desperate for relief. This article addresses these considerations by providing a foundation of clinical information that nurses should understand as they advise patients who are receiving, or curious about ketamine, as well as by discussing the regulatory, ethical, and nursing implications of using ketamine in the treatment of mental health disorders."

Journal • Anesthesia • CNS Disorders • Depression • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry