2024
Efficacy and Safety of Esmethadone (REL-1017) in Patients With Major Depressive Disorder and Inadequate Response to Standard Antidepressants: A Phase 3 Randomized Controlled Trial.
Fava M, Stahl S, Pani L, De Martin S, Cutler A, Maletic V, Gorodetzky C, Vocci F, Sapienza F, Kosten T, Kröger C, Champasa P, O'Gorman C, Guidetti C, Alimonti A, Comai S, Mattarei A, Folli F, Bushnell D, Traversa S, Inturrisi C, Manfredi P, Pappagallo M. Efficacy and Safety of Esmethadone (REL-1017) in Patients With Major Depressive Disorder and Inadequate Response to Standard Antidepressants: A Phase 3 Randomized Controlled Trial. The Journal Of Clinical Psychiatry 2024, 85 PMID: 38917366, DOI: 10.4088/jcp.24m15265.Peer-Reviewed Original ResearchConceptsMontgomery-Asberg Depression Rating ScaleIntent-to-treatIntent-to-treat analysisStandard antidepressantsDepressive disorderPost hoc analysisBaseline Montgomery-Asberg Depression Rating ScaleInadequate response to standard antidepressantsSevere depressionPost hoc analysis of patientsDepression Rating ScaleMajor depressive disorderAnalysis of patientsAdverse eventsMontgomery-AsbergConsistent with prior studiesPlacebo-controlled trialRating ScaleEfficacy measuresPer-protocolIntent-to-treat populationTreatment adherencePhase 3 randomized controlled trialsAdjunctive treatmentMDD
2023
A double-blind, randomized controlled study of the effects of celecoxib on clinical symptoms and cognitive impairment in patients with drug-naïve first episode schizophrenia: pharmacogenetic impact of cyclooxygenase-2 functional polymorphisms
Wang D, Chen D, Xiu M, Wang L, Kosten T, Zhang X. A double-blind, randomized controlled study of the effects of celecoxib on clinical symptoms and cognitive impairment in patients with drug-naïve first episode schizophrenia: pharmacogenetic impact of cyclooxygenase-2 functional polymorphisms. Neuropsychopharmacology 2023, 49: 893-902. PMID: 37903861, PMCID: PMC10948781, DOI: 10.1038/s41386-023-01760-8.Peer-Reviewed Original ResearchFirst-episode SCZ patientsClinical symptomsSCZ patientsCOX2 inhibitorsCyclooxygenase-2Drug-naïve first-episode schizophreniaCognitive impairmentCentral nervous system inflammationNervous system inflammationPlacebo-controlled trialSubscale scoresPANSS total scoreFirst-episode schizophreniaEffect of celecoxibCase-control studyPathogenesis of schizophreniaNegative Syndrome ScaleArachidonic acid pathwayCOX-2 geneCelecoxib 400Pharmacogenetic impactRs5275 polymorphismPlacebo groupSystem inflammationPANSS total