2023
Efficacy and Safety of Iclepertin (BI 425809) in Patients With Schizophrenia: CONNEX, A Phase III Randomized Controlled Trial Program
Wunderlich G, Blahova Z, Hake S, Ikezawa S, Marder S, Falkai P, Krystal J. Efficacy and Safety of Iclepertin (BI 425809) in Patients With Schizophrenia: CONNEX, A Phase III Randomized Controlled Trial Program. CNS Spectrums 2023, 28: 229-229. DOI: 10.1017/s1092852923001530.Peer-Reviewed Original ResearchCognitive impairmentEfficacy endpointVirtual Reality Functional Capacity Assessment ToolCognitive symptomsPlacebo-controlled parallel-group trialKey secondary efficacy endpointsN-methyl-D-aspartate receptorsSafety extension studyPrimary efficacy endpointSecondary efficacy endpointsParallel-group trialPhase II trialPoor functional outcomeComposite T-scoreMulti-center studyPhase III programRole of glutamateLong-term safetyScale total scoreDemonstration of efficacyGlycine transporter 1Industry-sponsored studiesCapacity assessment toolII trialTolerability dataEfficacy and safety of iclepertin (BI 425809) in patients with schizophrenia: CONNEX, a Phase III randomised controlled trial programme
Falkai P, Reuteman-Fowler C, Blahova Z, Ikezawa S, Marder S, Krystal J. Efficacy and safety of iclepertin (BI 425809) in patients with schizophrenia: CONNEX, a Phase III randomised controlled trial programme. European Psychiatry 2023, 66: s637-s637. PMCID: PMC10661489, DOI: 10.1192/j.eurpsy.2023.1325.Peer-Reviewed Original ResearchCognitive impairmentEfficacy endpointVirtual Reality Functional Capacity Assessment ToolCognitive symptomsJazz PharmaceuticalsPlacebo-controlled parallel-group trialBoehringer IngelheimKey secondary efficacy endpointsN-methyl-D-aspartate receptorsSafety extension studyPrimary efficacy endpointSecondary efficacy endpointsParallel-group trialPhase II trialPoor functional outcomeComposite T-scorePhase III programRole of glutamateLong-term safetyScale total scoreGrant/research supportDemonstration of efficacyGlycine transporter 1Industry-sponsored studiesCapacity assessment tool
2022
Long-term safety of ketamine and esketamine in treatment of depression
Nikayin S, Murphy E, Krystal JH, Wilkinson ST. Long-term safety of ketamine and esketamine in treatment of depression. Expert Opinion On Drug Safety 2022, 21: 777-787. PMID: 35416105, DOI: 10.1080/14740338.2022.2066651.Peer-Reviewed Original ResearchConceptsLong-term safetyClinical trialsRacemic ketamineLong-term safety effectsRapid-acting antidepressant effectsLower urinary tract symptomsKetamine/esketamineTreatment-resistant depressionUrinary tract symptomsCommon side effectsTreatment of depressionLong-term impairmentElevated heart ratePhase three clinical trialsTract symptomsAntidepressant effectsBlood pressureIncreased riskBladder pathologyEsketamineHeart ratePsychiatric disordersSide effectsCognitive impairmentHigh doses