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