2023
Long-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 ratingsPredictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray
Turkoz I, Nelson J, Wilkinson S, Borentain S, Macaluso M, Trivedi M, Williamson D, Sheehan J, Salvadore G, Singh J, Daly E. Predictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray. Psychiatry Research 2023, 323: 115165. PMID: 37019044, DOI: 10.1016/j.psychres.2023.115165.Peer-Reviewed Original ResearchConceptsTreatment-resistant depressionEsketamine nasal sprayNasal sprayDay 28Day 8Clinical Global Impression-Severity scoreCGI-S scoresCurrent depressive episodePredictors of responsePlacebo nasal sprayIdentification of predictorsOral antidepressantsBaseline patientAcute trialPooled analysisDepressive episodeRemissionPsychiatric characteristicsPatientsSignificant anxietyYounger ageTreatment assignmentPotential predictorsPhase 3Predictors
2018
Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD)
Fava M, Freeman MP, Flynn M, Judge H, Hoeppner BB, Cusin C, Ionescu DF, Mathew SJ, Chang LC, Iosifescu DV, Murrough J, Debattista C, Schatzberg AF, Trivedi MH, Jha MK, Sanacora G, Wilkinson ST, Papakostas GI. Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD). Molecular Psychiatry 2018, 25: 1592-1603. PMID: 30283029, PMCID: PMC6447473, DOI: 10.1038/s41380-018-0256-5.Peer-Reviewed Original ResearchConceptsTreatment-resistant depressionSingle doseActive placeboSubanesthetic dosesIntravenous ketamineAdult treatment-resistant depressionTransient blood pressure elevationTransient antidepressant effectsBlood pressure elevationPlacebo-controlled studyDose-ranging trialInfusion of ketaminePrimary outcome measureAbility of ketamineCurrent depressive episodeSingle intravenous doseNMDA receptor antagonistTime interaction effectsMeaningful efficacyAntidepressant doseGreater dissociative symptomsAdjunctive therapyAntidepressant effectsEligible subjectsSecondary outcomes