[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia-diagnosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia-diagnosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100619463","early-phase-1-single-and-multiple-ascending-doses-of-ntx-253-in-healthy-participants-and-participants-with-stable-schizophrenia-100619463",false,"NCT07344948","Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia","A First in Human, Phase 1\u002F1b Study of Single and Multiple Ascending Dosing Administration of NTX110253 in Healthy Participants and Participants With Stable Schizophrenia","Primary Inclusion Criteria:\n\n* Male or non-pregnant, non-lactating female participants, ages 18-55 who are not of childbearing potential, with a truly abstinent lifestyle, or agrees to use medically acceptable forms of birth control\n* Part 1 a\u002Fb, Part 2 Cohort 7 only: Body mass index (BMI) within the range ≥18.0 to ≤30.0 kg\u002Fm2\n* Participants in the food effect cohort must be willing to eat a single high fat breakfast\n* (Part 2 only): Stable schizophrenia participants (schizophrenia cohorts only)\n* Body mass index (BMI) within the range ≥17.5 to ≤36.0 kg\u002Fm2\n* Positive and Negative Syndrome Scale (PANSS) total score \\\u003C80 at screening\n\nPrimary Exclusion Criteria:\n\n* (Part 1a\u002Fb, Part 2 Healthy): History of or current clinically significant medical or mental illness\n* Cancer diagnosis\u002Ftreatment in the past 7 years\n* Acute or chronic gastrointestinal conditions that would interfere with drug tolerance or absorption\n* Any clinically significant, abnormal 12 lead ECG\n* Part 2: Any primary DSM-5TR disorder other than schizophrenia\n* Participants with schizophrenia who are considered resistant\u002Frefractory to antipsychotic treatment by history; history of clozapine use.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},73,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","This study will assess the safety, tolerability, and pharmacokinetics of NTX-253 following oral administration in both healthy adult participants as well as adult participants with stable schizophrenia.",[28,29],"Healthy Participants","Schizophrenia Diagnosis",[31,32,33,34,35,36,37,38],"Phase 1","Healthy volunteer","Schizophrenia","Pharmacokinetics","Single ascending dose","Multiple ascending dose","Food effect","Safety","RECRUITING","2026-01-07",{"date":42,"type":43},"2026-01-15","ACTUAL",{"date":45,"type":43},"2025-10-03",{"date":47,"type":22},"2026-05",{"name":49,"class":50},"Neurosterix","INDUSTRY",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":51},"100613421","validation-of-a-voice-management-program-in-schizophrenia-vvoice-maps-100613421","NCT07266376","Validation of a VOICE MAnagement Program in Schizophrenia VVoice MAPS","Validation of a VOICE MAnagement Program in Schizophrenia","PROGEVs","Inclusion Criteria\n\nConsenting patients over 18 years of age will be enrolled in the study if they meet all of the following criteria:\n\n* Diagnosis: Fulfill DSM-5 criteria for schizophrenia or schizoaffective disorder.\n* Resistant AVHs: Present treatment-resistant auditory verbal hallucinations (AVHs), defined as the persistence of daily hallucinations without remission despite adequate antipsychotic medication for at least 3 months.\n* Motivation: Express a request for relief from voices.\n* Treatment Setting: Are outpatients being treated in psychiatric departments at the Public Mental Health Institution of Guadeloupe or the University Hospital Center of Nîmes.\n* Severity: Have a score of greater than 9 on the Psychotic Symptom Rating Scale - Auditory Hallucinations subscale (PSYRATS-AH).\n\nExclusion Criteria :\n\nPatients will be excluded from the study if they meet any of the following criteria:\n\n* Participation in another study: Currently taking part in another clinical trial or within the exclusion period of another study.\n* Consent refusal: Refuse to sign the written informed consent.\n* Inability to provide informed consent: Failure or impossibility to provide the patient with sufficient information to allow an informed decision.\n* Severe substance abuse: Presence of severe substance use disorder.\n* Acute somatic decompensation: Experiencing an acute medical condition that may compromise participation in the study.",{"count":61,"type":22},116,[63],"NA","Approximately 25-50% of patients with schizophrenia experience treatment-resistant Auditory Verbal Hallucinations (AVHs), which contribute to the development of associated psychopathological disorders (e.g., anxiety, depression, suicidal ideation). Various validated psychotherapeutic strategies and tools for managing treatment-resistant AVHs have been combined into an integrative therapeutic program. The main objective of this study is to evaluate the efficacy of this program in reducing the frequency and intensity of AVHs, as well as its impact on comorbid psychopathology (e.g., depression, anxiety, self-esteem, substance use) in patients with schizophrenia or schizoaffective disorder who experience treatment-resistant AVHs.",[66,29],"Mental Disorder",[33,68,69,70],"Auditory Verbal Hallucinations","Groupal Intervention","Integrative Approach","NOT_YET_RECRUITING","2025-12-03",{"date":74,"type":43},"2025-12-05",{"date":76,"type":22},"2026-01-05",{"date":78,"type":22},"2027-01-05",{"name":80,"class":81},"Centre Hospitalier Universitaire de la Guadeloupe","OTHER"]