[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"irritability-associated-with-autism-spectrum-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:irritability-associated-with-autism-spectrum-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,62,85],{"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},"100614834","phase-3-a-study-of-karxt--karx-ec-for-treatment-of-irritability-in-children-and-adolescents-with-autism-100614834",false,"NCT07284745","A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder","Inclusion Criteria\n\n* Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.\n* Participants must have ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).\n\nExclusion Criteria\n\n* Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).\n* Exception Include: Participants with comorbid ADHD, provided that attention deficit\u002Fhyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.\n* Participants must not have history\u002Fpresence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.\n* Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.\n* Other protocol-defined Inclusion\u002FExclusion criteria may apply.","ALL","5 Years","17 Years",{"count":20,"type":21},176,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.",[27],"Irritability Associated With Autism Spectrum Disorder",[29,30],"Cobenfy","Autism Spectrum Disorder","NOT_YET_RECRUITING","2026-06-29",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":21},"2026-09-11",{"date":39,"type":21},"2029-07-05",{"name":41,"class":42},"Bristol-Myers Squibb","INDUSTRY",40,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":25,"conditions":53,"keywords":54,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100614915","phase-3-a-study-of-karxt--karx-ec-for-treatment-of-irritability-in-children-and-adolescents-with-autism-spectrum-disorder-100614915","NCT07285798","A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder","Inclusion Criteria\n\n* Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.\n* Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).\n\nExclusion Criteria\n\n* Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).\n* Exception Include: Participants with comorbid ADHD, provided that attention deficit\u002Fhyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.\n* Participants must not have history\u002Fpresence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.\n* Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.\n* Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":20,"type":21},[24],[27],[30],"2026-06-26",{"date":34,"type":35},{"date":37,"type":21},{"date":59,"type":21},"2029-08-04",{"name":41,"class":42},54,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100570394","phase-3-multicenter-study-of-lumateperone-for-the-treatment-of-irritability-associated-with-autism-spectrum-disorder-asd-in-pediatric-patients-100570394","NCT06706674","Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients","A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age","Inclusion Criteria:\n\n1. All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.\n2. Able to provide consent as follows:\n\n   1. The patient's LAR must provide written, informed consent.\n   2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent.\n3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.\n4. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);\n5. ABC-I subscale score of \\>18 at Screening and Baseline;\n6. CGI-S score \\> 4 with respect to irritability associated with ASD at Screening and Baseline.\n\nExclusion Criteria:\n\n1. Has a primary psychiatric diagnosis other than ASD. Exceptions include:\n\n   1. Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.\n   2. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).\n2. History or current diagnosis of Rett syndrome or Fragile X syndrome;\n3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or\n\n   1. At Screening, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;\n   2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or\n   3. The patient is considered to be an imminent danger to themselves or others.",{"count":70,"type":21},174,[24],"This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).",[27],"RECRUITING","2025-07-03",{"date":77,"type":35},"2025-07-08",{"date":79,"type":35},"2024-12-06",{"date":81,"type":21},"2027-04",{"name":83,"class":42},"Intra-Cellular Therapies, Inc.",39,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":67,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":72,"conditions":93,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":100,"locationsCount":101},"100569142","phase-3-multicenter-study-of-lumateperone-for-the-treatment-of-irritability-associated-with-autism-spectrum-disorder-in-pediatric-patients-100569142","NCT06690398","Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients","Inclusion Criteria:\n\n1. All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.\n2. Able to provide consent as follows:\n\n   1. The patient's LAR must provide written, informed consent.\n   2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent.\n3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.\n4. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);\n5. ABC-I subscale score of \\>18 at Screening and Baseline;\n6. CGI-S score \\> 4 with respect to irritability associated with ASD at Screening and Baseline.\n\nExclusion Criteria:\n\n1. Has a primary psychiatric diagnosis other than ASD. Exceptions include:\n\n   1. Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.\n   2. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).\n2. History or current diagnosis of Rett syndrome or Fragile X syndrome;\n3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or\n\n   1. At Screening, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;\n   2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or\n   3. The patient is considered to be an imminent danger to themselves or others.",{"count":70,"type":21},[24],[27],"2025-07-02",{"date":96,"type":35},"2025-07-04",{"date":98,"type":35},"2024-11-22",{"date":81,"type":21},{"name":83,"class":42},37]