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 ratingsArketamine as adjunctive therapy for treatment-resistant depression: A placebo-controlled pilot study
Leal G, Souza-Marques B, Mello R, Bandeira I, Caliman-Fontes A, Carneiro B, Faria-Guimarães D, Guerreiro-Costa L, Jesus-Nunes A, Silva S, Lins-Silva D, Fontes M, Alves-Pereira R, Cordeiro V, Rugieri-Pacheco S, Santos-Lima C, Correia-Melo F, Vieira F, Sanacora G, Lacerda A, Quarantini L. Arketamine as adjunctive therapy for treatment-resistant depression: A placebo-controlled pilot study. Journal Of Affective Disorders 2023, 330: 7-15. PMID: 36871913, DOI: 10.1016/j.jad.2023.02.151.Peer-Reviewed Original ResearchConceptsTreatment-resistant depressionAntidepressant effectsPlacebo-controlled pilot studyPilot studyMain efficacy analysisAdjunctive therapyAdverse eventsOne-week intervalEfficacy analysisPreclinical dataFlexible dosesClinical trialsPilot trialHuman trialsSide effectsRacemic ketaminePlaceboFirst weekKetamineTrialsTreatment effectsSignificant differencesDepressionEffects modelParallel design
2022
Efficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial
Dwyer J, Landeros-Weisenberger A, Johnson J, Londono Tobon A, Flores J, Nasir M, Couloures K, Sanacora G, Bloch M. Efficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial. FOCUS The Journal Of Lifelong Learning In Psychiatry 2022, 20: 241-251. PMID: 37153136, PMCID: PMC10153503, DOI: 10.1176/appi.focus.22020004.Peer-Reviewed Original ResearchTreatment-resistant depressionDepression Rating ScaleIntravenous ketamineClinical trialsAdolescent treatment-resistant depressionAdult treatment-resistant depressionPlacebo-controlled clinical trialSignificant short-term efficacySerious adverse eventsPrimary outcome measureSingle intravenous infusionChildren's Depression Rating ScaleCrossover clinical trialShort-term efficacyMajor depressive disorderSingle ketamine infusionSymptoms 24 hoursLater time pointsKetamine’s safetyAdverse eventsAntidepressant medicationKetamine infusionPediatric populationSignificant morbidityIntravenous infusion