2023
Single-Dose Psilocybin Treatment for Major Depressive Disorder
Raison C, Sanacora G, Woolley J, Heinzerling K, Dunlop B, Brown R, Kakar R, Hassman M, Trivedi R, Robison R, Gukasyan N, Nayak S, Hu X, O’Donnell K, Kelmendi B, Sloshower J, Penn A, Bradley E, Kelly D, Mletzko T, Nicholas C, Hutson P, Tarpley G, Utzinger M, Lenoch K, Warchol K, Gapasin T, Davis M, Nelson-Douthit C, Wilson S, Brown C, Linton W, Johnson M, Ross S, Griffiths R. Single-Dose Psilocybin Treatment for Major Depressive Disorder. JAMA 2023, 330: 843-853. PMID: 37651119, PMCID: PMC10472268, DOI: 10.1001/jama.2023.14530.Peer-Reviewed Original ResearchConceptsMajor depressive disorderSheehan Disability Scale scoresAdverse eventsDisability scale scorePsilocybin treatmentDay 43Scale scoreSecondary outcomesSingle doseDepressive disorderExclusion criteriaPsychological supportMontgomery-Asberg Depression Rating Scale scoreSerious treatment-emergent adverse eventsDay 8Key secondary outcome measuresTreatment-emergent adverse eventsDepression Rating Scale scoresActive substance use disorderFifth Edition diagnosisIdentical-appearing capsulesOverall adverse eventsPhase 2 trialSerious adverse eventsSevere adverse eventsLong-term safety and maintenance of response with esketamine nasal spray in participants with treatment-resistant depression: interim results of the SUSTAIN-3 study
Zaki N, Chen L, Lane R, Doherty T, Drevets W, Morrison R, Sanacora G, Wilkinson S, Popova V, Fu D. Long-term safety and maintenance of response with esketamine nasal spray in participants with treatment-resistant depression: interim results of the SUSTAIN-3 study. Neuropsychopharmacology 2023, 48: 1225-1233. PMID: 37173512, PMCID: PMC10267177, DOI: 10.1038/s41386-023-01577-5.Peer-Reviewed Original ResearchConceptsTreatment-resistant depressionEsketamine treatmentMontgomery-Åsberg Depression Rating Scale (MADRS) total scoreCommon treatment-emergent adverse eventsLong-term extension studyTreatment-emergent adverse eventsEsketamine nasal sprayMean cumulative durationLong-term tolerabilityNew safety signalsHealth-related qualityMaintenance of responseLong-term treatmentMajor depressive disorderLong-term safetyPhase 3Scale total scoreMaintenance phaseOral antidepressantsData cutoffAdverse eventsMaintenance treatmentSustained efficacyEligible participantsDepression ratings
2019
EFFICACY AND SAFETY OF ESKETAMINE NASAL SPRAY PLUS AN ORAL ANTIDEPRESSANT IN ELDERLY PATIENTS WITH TREATMENT-RESISTANT DEPRESSION
Ochs-Ross R, Daly E, Zhang Y, Lane R, Lim P, Foster K, Hough D, Manji H, Drevets W, Sanacora G, Adler C, McShane R, Gaillard R, Singh J. EFFICACY AND SAFETY OF ESKETAMINE NASAL SPRAY PLUS AN ORAL ANTIDEPRESSANT IN ELDERLY PATIENTS WITH TREATMENT-RESISTANT DEPRESSION. American Journal Of Geriatric Psychiatry 2019, 27: s139-s140. DOI: 10.1016/j.jagp.2019.01.093.Peer-Reviewed Original ResearchEsketamine nasal sprayTreatment-emergent adverse eventsTreatment-resistant depressionPlacebo nasal sprayCommon treatment-emergent adverse eventsTreatment of TRDMADRS total scoreElderly patientsNasal sprayOral antidepressantsTotal scoreDay 28Montgomery-Åsberg Depression Rating Scale (MADRS) total scoreBaseline MADRS total scoreDouble-blind treatment phasePre-specified subgroup analysisFirst large clinical trialJanssen ResearchMean patient ageSafety of esketamineLarge clinical trialsNew safety concernsActive-controlled studyScale total scoreYears of age