esketamine IV (JNJ-54135419 IV) / J&J - LARVOL DELTA

Prediction of Drug-Drug Interactions After Esketamine Intranasal Administration Using a Physiologically Based Pharmacokinetic Model. (PubMed, Clin Pharmacokinet) - "This PBPK model of the intranasal route adequately described the pharmacokinetics and DDI of intranasal esketamine/noresketamine with potential perpetrator and victim drugs. This work was used to support regulatory submissions of SPRAVATO."

Journal • PK/PD data • CYP3A4

The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy. (clinicaltrials.gov) - P2/3 | N=246 | Recruiting | Sponsor: Beijing Tiantan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Pain

Analgesic Effects of Low-dose S-ketamine in Major Spine Fusion Surgery (clinicaltrials.gov) - P4 | N=164 | Recruiting | Sponsor: Peking University First Hospital | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2021 ➔ Feb 2022

Enrollment open • Trial initiation date • Pain

Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression (clinicaltrials.gov) - P=N/A | N=364 | Recruiting | Sponsor: Peking University First Hospital | Trial completion date: Dec 2021 ➔ Aug 2022 | Trial primary completion date: Nov 2021 ➔ Jul 2022

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

Esketamine vs. Ketorolac for Prevention of Postoperative Pain and Cognitive Dysfunction After Total Knee Arthroplasty (clinicaltrials.gov) - P=N/A | N=160 | Recruiting | Sponsor: Tianjin Medical University General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Cognitive Disorders • Orthopedics • Pain • CXCL1 • ENO2 • IL17A • IL18 • IL23A • S100B • TNFA

EEPD: Effects of Esketamine on Postpartum Depression (clinicaltrials.gov) - P4 | N=500 | Not yet recruiting | Sponsor: Qinghai University

New P4 trial • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

American Journal of Psychiatry Publishes International Ketamine and Esketamine Treatment Guidance Led by Braxia Scientific CEO Dr. Roger Mcintyre (PRNewswire) - "Braxia Scientific...is pleased to announce the American Journal of Psychiatry, the most widely read psychiatric journal in the world, has published the International Expert Opinion and Implementation Guidance (the 'Guidelines') for the clinical use of rapid-acting Ketamine and Esketamine for treatment-resistant depression (TRD)."

Clinical guideline • CNS Disorders • Depression

Intranasal Esketamine to Maintain the Antidepressant Response to IV Racemic Ketamine (clinicaltrials.gov) - P; N=10; Completed; Sponsor: Psych Atlanta

Clinical • New trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer (clinicaltrials.gov) - P=N/A; N=180; Recruiting; Sponsor: Yangzhou University

New trial • Breast Cancer • CNS Disorders • Depression • Mood Disorders • Oncology • Psychiatry • Solid Tumor • LEP

Immunoinflammatory Regulation of Esketamine in Septic Patients (clinicaltrials.gov) - P4; N=100; Not yet recruiting; Sponsor: Wuhan Union Hospital, China

New P4 trial • Anesthesia • Immunology • Infectious Disease • Inflammation • Septic Shock • CD19 • CD4 • IL10 • IL17A • IL2 • IL4 • IL6 • NCAM1 • TNFA

Antisuicidal and antidepressant effects of ketamine and esketamine in patients with baseline suicidality: A systematic review. (PubMed, J Psychiatr Res) - "Previous research has shown that intranasal esketamine and intravenous ketamine can rapidly decrease the severity of depressive symptoms and suicidal ideation. Based on the overall pooled samples, studies were assessed to be relatively safe, and the continual inclusion of this study population in future clinical trials is encouraged. Future research should aim to assess the longitudinal efficacy of ketamine in patients with baseline suicidality."

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

[VIRTUAL] Ketamine and Esketamine in the Real-world: Practical Experiences from the Yale Psychiatric Hospital (ADAA 2021) - "The Yale Psychiatric Hospital has several years’ worth of experience providing both racemic ketamine (intravenously) and esketamine. The advantages and disadvantages of each treatment based on this experience will be discussed, along with real-world implications. This presentation will also include the results and clinical implications of a pilot randomized trial of cognitive behavioral therapy aimed to sustain the antidepressant effects of intravenous ketamine in patients with treatment-resistant depression (N=28)."

Clinical • Real-world evidence • CNS Disorders • Depression • Psychiatry

[VIRTUAL] Esketamine and Racemic Ketamine’s Effects on Anhedonia in Treatment-Resistant Depression: A Randomized, DoubleBlinded, Clinical Trial (CINP 2021) - "34 subjects received intravenous esketamine (0.25mg/ kg) while another 29 subjects received intravenous racemic ketamine (0.5mg/kg), both groups undergoing infusion for 40 minutes. The results suggest antianhedonic effects can be attributed to esketamine and racemic ketamine infusions. Furthermore, there was no difference in the way the rapid improvement in anhedonia severity was affected by the interventions. In conclusion, in MDD patients that have experienced therapeutic failure, both esketamine and racemic ketamine can induce similar antianhedonic effects."

Clinical • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Champignon Brands opens third ketamine clinic in Ottawa (Proactiveinvestors) - "Champignon Brands Inc...is opening a third ketamine clinic in Ottawa, it announced Monday. The new clinic is the first community-based centre in the city that provides ketamine treatment for adults with depression, the Vancouver-based company said in a statement....The CRTCE multidisciplinary outpatient clinical research facility...in Canada – specializes in providing breakthrough rapid onset treatments for depression, such as intravenous ketamine and intranasal esketamine, which help patients suffering from several treatment-resistant conditions such as major depressive disorder or bipolar disorder."

Commercial • CNS Disorders • Depression

Effect of Low-dose Esketamine Combined With Target-controlled Infusion of Propofol for Painless Gastrointestinal Endoscopy (clinicaltrials.gov) - P=N/A; N=1000; Recruiting; Sponsor: Tianjin Union Medical Center

Clinical • New trial • Anesthesia • Gastrointestinal Disorder • Pain

Combination of Electroconvulsive Therapy Alternating With Intravenous Esketamine Can Lead to Rapid Remission of Treatment Resistant Depression. (PubMed, J ECT) - No abstract available

Clinical • Journal • CNS Disorders • Depression • Epilepsy • Mood Disorders • Psychiatry

ES-CS: The Efficacy and Safety of S-ketamine in Elective Cesarean Section (clinicaltrials.gov) - P=N/A; N=402; Not yet recruiting; Sponsor: Beijing Obstetrics and Gynecology Hospital

Clinical • New trial • Anesthesia • CNS Disorders • Depression • Mood Disorders • Psychiatry

S-ketamine Prevents Postoperative Pain and Cognitive Dysfunction After Tibial Fracture (clinicaltrials.gov) - P=N/A; N=120; Not yet recruiting; Sponsor: Tianjin Medical University General Hospital

Clinical • New trial • Cognitive Disorders • Musculoskeletal Diseases • Orthopedics • Pain

Association between dynamic resting-state functional connectivity and ketamine plasma levels in visual processing networks. (PubMed, Sci Rep) - "We assessed data from 27 healthy subjects who underwent two 3 T resting-state fMRI scans, once under subanesthetic, intravenous esketamine and once under placebo, in a randomized, cross-over manner. Dynamic rsFC in sensory processing networks might be a promising target for future investigations of ketamine's antidepressant properties. Mechanistically, sensitivity of visual networks for esketamine's effects may result from their high expression of NMDA-receptors."

Journal • CNS Disorders • Depression • Psychiatry

Perioperative intravenous S-ketamine for acute postoperative pain in adults: A systematic review and meta-analysis. (PubMed, J Clin Anesth) - "Intravenous S-ketamine as an adjunct to general anesthesia is effective for assisting analgesia and decreases the intensity of pain and opioid requirements in a short period of time after surgery, but it may increase the psychotomimetic adverse event rate. Overall, the level of certainty is moderate to low."

Journal • Retrospective data • Review • Anesthesia • Cardiovascular • Gastroenterology • Gynecology • Orthopedics • Pain

NMDA receptor ion channel activation detected in vivo with [F]GE-179 PET after electrical stimulation of rat hippocampus. (PubMed, J Cereb Blood Flow Metab) - "Seven rats had no stimulation, five received pulsed 400 µA supra-threshold 60 Hz stimulation alone, and three received intravenous S-ketamine injection prior to stimulation. Rats injected with S-ketamine prior to stimulation maintained non-stimulated levels of [F]GE-179 uptake during stimulation. In conclusion, PET visualisation of focal [F]GE-179 uptake during electrically activated NMDAR-ICs and the demonstration of specificity for PCP sites by blockade with S-ketamine support the in vivo utility of [F]GE-179 PET as a use-dependent marker of NMDAR-IC activation."

Journal • Preclinical • CNS Disorders • Epilepsy

The effect of intravenous, intranasal, and oral ketamine in mood disorders: A meta-analysis. (PubMed, J Affect Disord) - "The short-term efficacy of intravenous and intranasal ketamine/esketamine for adults with TRD was established. Interpreting the efficacy of oral ketamine was limited by the need for studies with larger samples across independent sites. No conclusions regarding comparative efficacy of the disparate formulations and routes of delivery can be derived from this analysis. Direct comparative studies are needed to further inform treatment options for TRD."

Journal • Retrospective data • Review • Bipolar Disorder • CNS Disorders • Depression • Hepatology • Mood Disorders • Psychiatry

OS-PCC: Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery (clinicaltrials.gov) - P=N/A; N=220; Recruiting; Sponsor: Göteborg University; Trial completion date: Dec 2023 ➔ Dec 2024; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity • Pain

Is a hip flip the right trick? (PubMed, Emerg Med J) - "The patient received sedation and analgesia with 75 mg propofol and 9 mg esketamine intravenously, and a closed reduction procedure was attempted using manual flexion, adduction, traction and internal rotation...The closed reduction procedure should be performed by using extension, abduction, traction and internal rotation.The femoral head is not reduced centrally in the acetabulum and the closed reduction procedure should be repeated more forcefully.A dual-mobility cup is used and the liner is not in place anymore. Revision surgery is required.For answer see page 2."

Journal • Pain

Assessment of Ketamine’s Effects on Dynamic Resting State Functional Connectivity (SOBP 2020) - " Study 1: we utilized eight complementary, whole-brain, dynamic rsFC analysis pipelines to assess the impact of sub-anesthetic, intravenous esketamine in 27 healthy individuals assessed twice with 3T resting-state fMRI in a randomized, placebo-controlled, double-blind, cross-over study. Our multi-methodological approach suggests that ketamine’s impact on dynamic rsFC may be most robust in and between visual processing networks. Conceptually, this may be in accordance with ketamine’s role as a psychosis model as these networks are implicated in pathophysiology. Considering the increasing focus placed on ketamine’s metabolites, assessment of their neurobiological effects is pressing."

CNS Disorders • Psychiatry