[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cognitive-impairment-associated-with-schizophrenia-cias\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cognitive-impairment-associated-with-schizophrenia-cias":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100607663","phase-2-a-study-to-evaluate-kyn-5356-in-adults-with-cognitive-impairment-associated-with-schizophrenia-100607663",false,"NCT07191483","A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of KYN-5356 as Adjunctive Treatment in Adults With Cognitive Impairment Associated With Schizophrenia","Inclusion Criteria:\n\n* Has an established primary psychiatric diagnosis of schizophrenia\n* Clinically stable and in the residual (nonacute) phase of their illness for at least 8 weeks before screening in the judgement of the investigator\n* Diagnosis of schizophrenia for at least 1 year before screening\n* Must be in ongoing maintenance antipsychotic monotherapy on a stable medication treatment regimen for ≥ 2 months before screening, including concomitant psychotropic medications.\n* Male or female, aged ≥18 and ≤55 years\n* Has a body mass index (BMI) between 18 and 40 kg\u002Fm2 Inclusive\n* Must exhibit capability to comply with all protocol procedures in the judgement of the investigator\n* Signed and dated written informed consent before screening in accordance with Good Clinical Practice.\n\nExclusion Criteria:\n\n* Currently being treated with more than 1 antipsychotic at the time of screening,\n* A score of 2 or higher on any of the individual items of the Modified Simpson-Angus Scale (mSAS) at screening\n* Moderate to severe substance use disorder (other than nicotine or caffeine, but including alcohol)\n* Evidence of unstable medical condition","ALL","18 Years","55 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of 3 different dose regiments of KYN-5356 and placebo for 28 days.\n\nParticipants will be randomized to one of 4 treatment groups: placebo, KYN-5356 low dose, KYN-5356 medium dose, KYN-5356 high dose.\n\nParticipants will be admitted to the clinic on Day -3 and will remain in residence at the clinic for 32 days, from baseline through the treatment period.\n\nParticipants will be administered investigational medicinal product on Days 1 through 28. Efficacy, safety, PK and exploratory PD assessments will be performed throughout the dosing period. Participants will be discharged on Day 29 after safety assessments are completed and return for a follow-up visit on Day 42.\n\nA subset of participants from selected sites will undergo electrophysiological assessments to evaluate the effect of KYN-5356 on neurophysiological measures of brain function.",[27],"Cognitive Impairment Associated With Schizophrenia (CIAS)",[29,30],"Schizophrenia","Cognitive Dysfunction","RECRUITING","2026-06-22",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":35},"2025-08-27",{"date":39,"type":21},"2026-12",{"name":41,"class":42},"Kynexis B.V.","INDUSTRY",15,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100627272","tis-for-improving-cognitive-impairment-associated-with-schizophrenia-100627272","NCT07446478","TIS for Improving Cognitive Impairment Associated With Schizophrenia","Efficacy and Safety of Time Interference Stimulation on Cognitive Impairment Associated With Schizophrenia","Inclusion Criteria:\n\n* Age 18-50 years old;\n* meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnostic criteria;\n* the diagnosis of schizophrenia is confirmed by the Structured Clinical Interview for DSM-5 (SCID-5);\n* the disease duration does not exceed 8 years;\n* 1-2 antipsychotic drugs are taken, and the treatment dose of antipsychotic drugs was stable for at least 1 week before enrollment. Mood stabilizers, antidepressants, and excessive benzodiazepines (lorazepam when 2 doses exceeded 2 mg\u002Fd) are not allowed;\n* The type of antipsychotic drugs remains unchanged during treatment, and the dose is adjusted by no more than 25%;\n* Impaired functioning in daily activities;\n* The Global Deficit Score (GDS) for the MATRICS Consensus Cognitive Battery (MCCB) reaches 0.5 or above;\n* Agree to participate in this study and provide written informed consent\n\nExclusion Criteria:\n\n* Presence of other psychiatric comorbidities, intellectual disability, obvious mood symptoms, or substance use disorders (other than caffeine and\u002For tobacco);\n* with clear drug-induced extrapyramidal reaction;\n* A history of seizures, meningitis, or encephalitis;\n* with contraindications to transcranial electrical stimulation;\n* History of intracranial tumors or surgery;\n* history of severe head trauma;\n* have received other regimens of electrical or magnetic therapy in 1 month before enrollment.","50 Years",{"count":53,"type":21},10,[55],"NA","This study aims to evaluate the efficacy and safety of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, and MRI data, will be collected at baseline and at the end of the 2-week intervention.",[27],[59,60,61],"schizophrenia","cognitive impairments","temporal interference stimulation","NOT_YET_RECRUITING","2026-03-12",{"date":65,"type":35},"2026-03-17",{"date":67,"type":21},"2026-03-15",{"date":69,"type":21},"2026-05-15",{"name":71,"class":72},"Central South University","OTHER",1]