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- || Spravato (esketamine intranasal) / J&J
PK/PD data, Journal: Prediction of Drug-Drug Interactions After Esketamine Intranasal Administration Using a Physiologically Based Pharmacokinetic Model. (Pubmed Central) - Aug 7, 2022
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.
- || esketamine IV (JNJ-54135419 IV) / J&J
Retrospective data, Review, Journal: Perioperative intravenous S-ketamine for acute postoperative pain in adults: A systematic review and meta-analysis. (Pubmed Central) - Jun 22, 2021
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.
- || Spravato (esketamine intranasal) / J&J
Clinical, Retrospective data, Review, Journal: Antisuicidal and antidepressant effects of ketamine and esketamine in patients with baseline suicidality: A systematic review. (Pubmed Central) - May 21, 2021
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.
- ketamine / Generic mfg.
[VIRTUAL] Ketamine and Esketamine in the Real-world: Practical Experiences from the Yale Psychiatric Hospital () - Mar 22, 2021 - Abstract #ADAA2021ADAA_440;
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).
- ketamine / Generic mfg.
[VIRTUAL] Esketamine and Racemic Ketamine’s Effects on Anhedonia in Treatment-Resistant Depression: A Randomized, DoubleBlinded, Clinical Trial () - Mar 7, 2021 - Abstract #CINP2021CINP_142;
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.
- || ketamine / Generic mfg.
Clinical, Journal, Head-to-Head: Efficacy and safety of adjunctive therapy using esketamine or racemic ketamine for adult treatment-resistant depression: A randomized, double-blind, non-inferiority study. (Pubmed Central) - Feb 16, 2021
Esketamine was non-inferior to ketamine for TRD 24 h following infusion. Both treatments were effective, safe, and well tolerated.
- || Spravato (esketamine intranasal) / J&J
Retrospective data, Review, Journal: The effect of intravenous, intranasal, and oral ketamine in mood disorders: A meta-analysis. (Pubmed Central) - Feb 16, 2021
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.
- || esketamine IV (JNJ-54135419 IV) / J&J
Clinical, Journal: Analgesic Effect of Intraoperative Intravenous S-Ketamine in Opioid-Naïve Patients After Major Lumbar Fusion Surgery Is Temporary and Not Dose-Dependent: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. (Pubmed Central) - Jan 21, 2021
Neither a 0.12 nor a 0.6 mg/kg/h infusion of intraoperative IV S-ketamine was superior to the placebo in reducing oxycodone consumption at 48 hours after lumbar fusion surgery in an opioid-naïve adult study population. Future studies should assess ketamine's feasibility in specific study populations who most benefit from reduced opioid consumption.
- || esketamine IV (JNJ-54135419 IV) / J&J
PK/PD data, Journal: Pharmacokinetics of S-ketamine and R-ketamine and their active metabolites after racemic ketamine or S-ketamine intravenous administration in dogs sedated with medetomidine. (Pubmed Central) - Jan 7, 2021
Future studies should assess ketamine's feasibility in specific study populations who most benefit from reduced opioid consumption. This study performed in dogs showed that RS-ketamine and S-ketamine combined with medetomidine showed enantioselective pharmacokinetics as S- and R-norketamine AUCs were different, but S-ketamine levels were identical.
- | ketamine / Generic mfg.
Journal: Association between dynamic resting-state functional connectivity and ketamine plasma levels in visual processing networks. (Pubmed Central) - Oct 31, 2020
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.
- |||| Spravato (esketamine intranasal) / J&J, esketamine IV (JNJ-54135419 IV) / J&J
Clinical: The BC College has mandated the same policy for oral ketamine and intranasal esketamine as for IV ketamine. Only anesthesiologists can give it in an accredited facility (like a hospital) that has resuscitation equipment. /6 (Twitter) - Oct 20, 2020
- | ketamine / Generic mfg.
Journal, HEOR: Comparative effectiveness of esketamine in the treatment of anhedonia in bipolar and unipolar depression. (Pubmed Central) - Oct 6, 2020
Although preliminary, present findings suggest that repeated subcutaneous esketamine infusions are effective for the treatment of anhedonia in both unipolar and bipolar depressed patients. These results need to be confirmed through replication in larger double-blinded controlled trials.
- | esketamine IV (JNJ-54135419 IV) / J&J
Journal: Is a hip flip the right trick? (Pubmed Central) - Jul 25, 2020
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.
- ketamine / Generic mfg.
Assessment of Ketamine’s Effects on Dynamic Resting State Functional Connectivity () - Apr 17, 2020 - Abstract #SOBP2020SOBP_1236;
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.
- || ketamine / Generic mfg., esketamine IV (JNJ-54135419 IV) / J&J
IV Esketamine, Ketamine Equally Effective for Resistant Depression https://t.co/FtjtN1G8Ml via @medscape (Twitter) - Apr 4, 2020
- | ketamine / generics
Clinical, Journal: S-Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain: A Placebo- Controlled Study in Healthy Male Individuals. (Pubmed Central) - Oct 17, 2019
P2/3
Behaviorally, S-ketamine seems to have produced an emotional and discrimination blunting effect for pain-related words. www.ClinicalTrials.gov, identifier NCT03915938.
- Spravato (esketamine intranasal) / J&J
Safety and Efficacy of Esketamine Nasal Spray in a Depressed Patient who was Being Treated With Tranylcypromine: A Case Report (Floridian Ballroom) - Oct 17, 2019 - Abstract #ACNP2019ACNP_693;
There were no elevations of blood pressure outside the normal range and there was no indication of a serotonin syndrome. Our patient is likely the first to be treated with this combination, although there are reports in the literature of patients treated with MAOIs and IV ketamine or IV S-ketamine.
- | ketamine / generics
Journal: Rapid antidepressant effect of S-ketamine in schizophrenia. (Pubmed Central) - May 1, 2019
Importantly, no relevant psychotic or dissociative symptoms occurred during the whole augmentation treatment period leading to a sustained remission of depressive symptoms and suicidality. Our safe and effective experience with intravenous S-ketamine might encourage researchers and clinicians to widen its administration range beyond the diagnosis of depression to enrich the current knowledge of ketamine effects in psychotic disorders.
- ||| Spravato (esketamine intranasal) / J&J
Trial completion: A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants (clinicaltrials.gov) - Mar 28, 2017
P1, N=65, Completed, Sponsor: Janssen Research & Development, LLC
Our safe and effective experience with intravenous S-ketamine might encourage researchers and clinicians to widen its administration range beyond the diagnosis of depression to enrich the current knowledge of ketamine effects in psychotic disorders. Recruiting --> Completed
- || Spravato (esketamine intranasal) / J&J
Trial primary completion date: A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants (clinicaltrials.gov) - Nov 1, 2016
P1, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed Trial primary completion date: Sep 2016 --> Jan 2017
- ||| Spravato (esketamine intranasal) / J&J
Enrollment open: A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants (clinicaltrials.gov) - Aug 22, 2016
P1, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Sep 2016 --> Jan 2017 Not yet recruiting --> Recruiting
- || Spravato (esketamine intranasal) / J&J
Trial initiation date: A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants (clinicaltrials.gov) - Jun 23, 2016
P1, N=60, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Initiation date: Apr 2016 --> Jul 2016
- ||| Spravato (esketamine intranasal) / J&J
New P1 trial: A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants (clinicaltrials.gov) - Apr 14, 2016
P1, N=60, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- | esketamine IV (JNJ-54135419 IV) / J&J
Trial completion: A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression (clinicaltrials.gov) - Jun 17, 2013
P2, N=30, Completed, Sponsor: Janssen Research & Development, LLC
Initiation date: Apr 2016 --> Jul 2016 Active, not recruiting --> Completed
- | esketamine IV (JNJ-54135419 IV) / J&J
New P2 trial: A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression (clinicaltrials.gov) - Jul 11, 2012
P2, N=30, Completed, Sponsor: Janssen Research & Development, LLC