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 ratings
2019
POST HOC ANALYSES 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. POST HOC ANALYSES OF ESKETAMINE NASAL SPRAY PLUS AN ORAL ANTIDEPRESSANT IN ELDERLY PATIENTS WITH TREATMENT-RESISTANT DEPRESSION. American Journal Of Geriatric Psychiatry 2019, 27: s140-s141. DOI: 10.1016/j.jagp.2019.01.094.Peer-Reviewed Original ResearchTreatment-resistant depressionMADRS total scoreOpen-label safety studyEsketamine nasal sprayLabel Safety StudyLS mean differenceNew oral antidepressantDuration of treatmentOnset of depressionInterim analysisOral antidepressantsYears of ageNasal sprayPrimary analysisElderly patientsTotal scoreMean changeLarge phase 3 studiesDay 25Mean differenceStage 2Safety studiesPrimary efficacy endpointPhase 3 studyUnexpected safety concernsEFFICACY 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 ageEfficacy 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. European Neuropsychopharmacology 2019, 29: s355-s356. DOI: 10.1016/j.euroneuro.2018.11.548.Peer-Reviewed Original ResearchLong-term safety of esketamine nasal spray plus oral antidepressant in patients with treatment-resistant depression: SUSTAIN-2 phase 3 study
Wajs E, Leah A, Morrison R, Daly E, Lane R, Lim P, Holder R, Sanacora G, Young A, Kasper S, Sulaiman A, Li C, Paik J, Manji H, Hough D, Drevets W, Singh J. Long-term safety of esketamine nasal spray plus oral antidepressant in patients with treatment-resistant depression: SUSTAIN-2 phase 3 study. European Neuropsychopharmacology 2019, 29: s44-s45. DOI: 10.1016/j.euroneuro.2018.11.1016.Peer-Reviewed Original Research
2018
S114. Efficacy and Safety of Intranasal Esketamine 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. S114. Efficacy and Safety of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression. Biological Psychiatry 2018, 83: s391. DOI: 10.1016/j.biopsych.2018.02.1005.Peer-Reviewed Original Research