[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Intra-Cellular Therapies, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":293},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,42,65,86,107,123,152,173,194,211,235,257,271],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100539097","phase-1-pet-study-to-evaluate-brain-receptor-occupancy-safety-and-pharmacokinetics-of-iti-1284-in-healthy-subjects-100539097",false,"NCT06299410","PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects","An Open-label, Positron Emission Tomography Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After a Single Sublingual Administration of ITI-1284 in Healthy Subjects","Inclusion Criteria:\n\n* Healthy male and female subjects between 18 and 55 years old (inclusive);\n* BMI inclusive of 18-32 kg\u002Fm2 at screening and a minimum weight of 50 kg;\n* Willingness to remain in the hospital research unit for the duration of the inpatient period.\n\nExclusion Criteria:\n\n* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;\n* Clinically significant abnormal findings in vital sign assessments, supine SBP \\> 140 mmHg or \\\u003C 90 mmHg, or supine DBP \\>90 mmHg or \\\u003C 50 mmHg or supine pulse rate \\> 100 bpm or \\\u003C 45 bpm at Screening;\n* History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;\n* Any condition which would preclude MRI or PET\u002FCT examination (eg, implanted metal, claustrophobia, unable to fit in PET\u002FCT or MRI scanners);\n* Contraindications based on any previous MRI or the study MRI performed prior to the baseline PET\u002FCT scan.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},42,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.",[28],"Healthy Volunteers","RECRUITING","2026-05-21",{"date":32,"type":33},"2026-05-26","ACTUAL",{"date":35,"type":33},"2024-04-11",{"date":37,"type":22},"2026-07",{"name":39,"class":40},"Intra-Cellular Therapies, Inc.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100557647","phase-2-a-study-to-assess-the-efficacy-and-safety-of-iti-1284-in-the-treatment-of-psychosis-associated-with-alzheimers-disease-100557647","NCT06540833","A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Psychosis Associated With Alzheimer's Disease","Inclusion Criteria:\n\n1. Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \\[LAR\\]) before the initiation of any study-specific procedures in accordance with local regulations;\n2. Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:\n\n   1. Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; or\n   2. Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;\n3. Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline;\n4. Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and\u002For Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline;\n5. CGI-S score ≥ 4 at Screening and Baseline;\n6. Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures;\n7. Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver);\n\nExclusion Criteria:\n\n1. Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (eg, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions:\n\n   1. Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;\n   2. Bipolar disorder;\n2. Risk for suicidal behavior during the course of their participation in the study or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and\u002For as assessed by C-SSRS; or the patient has had 1 or more suicide attempts within 2 years prior to Screening;\n3. The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee,\n4. The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia\n5. The patient is bedridden or has any significant medical condition that is unstable and would either:\n\n   1. Place the patient at undue risk from study drug or undergoing study procedures; or\n   2. Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study;\n6. The patient is in hospice or end-of-life care;",{"count":50,"type":22},370,[52],"PHASE2","This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.",[55],"Psychosis Associated With Alzheimer's Disease","2026-01-12",{"date":58,"type":33},"2026-01-13",{"date":60,"type":33},"2024-08-15",{"date":62,"type":22},"2027-10",{"name":39,"class":40},65,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100566160","phase-2-a-study-to-assess-the-efficacy-and-safety-of-iti-1284-in-the-treatment-of-agitation-associated-with-alzheimers-dementia-100566160","NCT06651567","A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia","A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study of the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Agitation Associated With Alzheimer's Dementia","Inclusion Criteria:\n\n* Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \\[LAR\\]) before the initiation of any study-specific procedures in accordance with local regulations;\n* Meets clinical criteria for Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:\n\n  * Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening; or\n  * Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;\n* Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition\n* Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation\u002FAggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;\n* CGI-S score ≥ 4 at Screening and Baseline;\n* Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;\n\nExclusion Criteria:\n\n* Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;\n* Has been diagnosed with one or more of the following psychiatric conditions:\n\n  * Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;\n  * Bipolar disorder;\n  * Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;\n* Has a significant risk for suicidal behavior during the course of their participation in the study, or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and\u002For as assessed by Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening;\n* The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.",{"count":73,"type":22},320,[52],"This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia",[77],"Agitation Associated With Alzheimer's Dementia","2026-01-09",{"date":56,"type":33},{"date":81,"type":33},"2024-10-22",{"date":83,"type":22},"2027-11",{"name":39,"class":40},69,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100570027","phase-2-study-of-iti-1284-as-monotherapy-treatment-in-patients-with-generalized-anxiety-disorder-100570027","NCT06701903","Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder","A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment","Inclusion Criteria:\n\n* Provide written informed consent before the initiation of any study specific procedures;\n* At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:\n\n  * HAM-A Total score of ≥ 22;\n  * HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;\n  * CGI-S score of ≥ 4;\n* History of inadequate response (\\\u003C 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire \\[ATRQ\\] for GAD) to at least 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least the minimum GAD-approved dose per package insert) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms.\n\nExclusion Criteria:\n\n* Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:\n\n  * Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;\n  * Bipolar Disorder;\n* MADRS total score \\> 18 at Screening or Baseline;\n* In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his\u002Fher participation in the study or\n\n  * At Screening, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 since the Screening Visit;\n  * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;\n  * At Screening or Baseline MADRS Item 10 score ≥ 5; or\n  * The patient is considered to be an imminent danger to him\u002Fherself or others based on the assessment of the Investigator;\n* Lifetime history of failure to respond to \\> 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (ie, at least the minimum dose approved for GAD per package insert) and for an adequate duration (ie, at least 6 weeks).",{"count":94,"type":22},570,[52],"This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.",[98],"Generalized Anxiety Disorder","2026-01-07",{"date":78,"type":33},{"date":102,"type":33},"2024-11-21",{"date":104,"type":22},"2027-06",{"name":39,"class":40},60,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":91,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":122,"locationsCount":85},"100552999","phase-2-study-of-iti-1284-as-an-adjunctive-treatment-in-patients-with-generalized-anxiety-disorder-100552999","NCT06480383","Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder","Inclusion Criteria:\n\n1. Provide written informed consent before the initiation of any study specific procedures;\n2. Male or female patients ≥ 18 years of age;\n3. At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:\n\n   1. HAM-A Total score of ≥ 22;\n   2. HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;\n   3. CGI-S score of ≥ 4;\n4. History of inadequate response (\\\u003C 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire \\[ATRQ\\] for GAD) to at least 1 GAD-approved treatment (ie, one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) taken at an adequate dose (at least the minimum GAD-approved dose per package insert) and duration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;\n5. Currently having an inadequate response to one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least the minimum GAD-approved dose per package insert) and duration (ie, for at least 6 weeks prior to Screening) and agrees to continue the same dosing regimen for the duration of the study.\n\nNOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure.\n\nExclusion Criteria:\n\n1. Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:\n\n   1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;\n   2. Bipolar Disorder;\n2. MADRS total score \\> 18 at Screening or Baseline;\n3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his\u002Fher participation in the study or\n\n   1. At Screening, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 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;\n   3. At Screening or Baseline MADRS Item 10 score ≥ 5; or\n   4. The patient is considered to be an imminent danger to him\u002Fherself or others based on the assessment of the Investigator.\n4. Lifetime history of failure to respond to \\> 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (ie, at least the minimum dose approved for GAD per package insert) and for an adequate duration (ie, at least 6 weeks).",{"count":114,"type":22},705,[52],"This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.",[98],{"date":78,"type":33},{"date":120,"type":33},"2024-08-05",{"date":104,"type":22},{"name":39,"class":40},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},"100533699","phase-3-safety-and-tolerability-trial-of-lumateperone-in-pediatric-patients-with-schizophrenia-bipolar-disorder-or-autism-spectrum-disorder-100533699","NCT06229210","Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder","An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder","Inclusion Criteria:\n\n* Able to provide consent as follows:\n\n  * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent;\n  * The patient must provide written assent to study enrollment;\n* Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder;\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).\n* Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.\n\nRollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:\n\n  * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.\n  * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary.\n* In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or\n\n  * 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  * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or\n  * At Screening or Baseline, scores \\> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or\n  * The patient is considered to be an imminent danger to him\u002Fherself or others.","5 Years","17 Years",{"count":133,"type":22},500,[135],"PHASE3","This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.",[138,139,140],"Schizophrenia","Bipolar Disorder","Autism Spectrum Disorder",[142],"Pediatric","2025-07-07",{"date":145,"type":33},"2025-07-08",{"date":147,"type":33},"2024-01-25",{"date":149,"type":22},"2027-12",{"name":39,"class":40},50,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":130,"maxAge":131,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},"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":160,"type":22},174,[135],"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).",[164],"Irritability Associated With Autism Spectrum Disorder","2025-07-03",{"date":145,"type":33},{"date":168,"type":33},"2024-12-06",{"date":170,"type":22},"2027-04",{"name":39,"class":40},39,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":180,"maxAge":131,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100544751","phase-3-multicenter-study-of-lumateperone-for-the-treatment-of-bipolar-depression-in-pediatric-patients-100544751","NCT06372964","Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients","A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years","Inclusion Criteria:\n\n1. Able to provide consent as follows:\n\n   * The Legally Authorized Representative (LAR) must provide written, informed consent.\n   * The patient must provide written assent;\n2. Male or female patients 10 to 17 years of age, inclusive;\n3. Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);\n4. Subject has a lifetime history of at least one manic or hypomanic episode.\n5. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;\n6. CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;\n7. Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \\[elevated mood\\] score ≤ 2) at Screening and Baseline.\n\nExclusion Criteria:\n\n1. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:\n\n   * Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been 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.\n2. Intellectual disability based on Investigator opinion and DSM-5 criteria\n3. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;\n4. Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;\n5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his\u002Fher 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. At Screening or Baseline, scores \\> 3 on Item 13 (suicidal ideation) on the CDRS-R; or\n   4. The patient is considered to be an imminent danger to him\u002Fherself or others.","10 Years",{"count":182,"type":22},384,[135],"This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).",[186],"Bipolar Depression",{"date":145,"type":33},{"date":189,"type":33},"2024-05-13",{"date":191,"type":22},"2027-05",{"name":39,"class":40},59,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":157,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":130,"maxAge":131,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":162,"conditions":202,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":209,"locationsCount":210},"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":160,"type":22},[135],[164],"2025-07-02",{"date":205,"type":33},"2025-07-04",{"date":207,"type":33},"2024-11-22",{"date":170,"type":22},{"name":39,"class":40},37,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":106},"100504619","phase-3-study-of-lumateperone-as-adjunctive-therapy-in-the-treatment-of-patients-with-major-depressive-disorder-100504619","NCT05850689","Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder","A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder","Inclusion Criteria:\n\n1. Male or female patients between the ages of 18 and 65 years, inclusive;\n2. Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and meets all of the following criteria:\n\n   1. The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening;\n   2. Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;\n   3. Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline;\n   4. Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;\n   5. Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.\n3. Currently having an inadequate response (less than 50% improvement) to 2 or more ADTs in the current MDE as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration:\n\n   1. citalopram\u002Fescitalopram\n   2. fluoxetine\n   3. paroxetine\n   4. sertraline\n   5. duloxetine\n   6. levomilnacipran\u002Fmilnacipran (if locally approved for MDD)\n   7. venlafaxine\u002Fdesvenlafaxine\n   8. bupropion\n   9. vilazodone\n   10. vortioxetine\n\nExclusion Criteria:\n\n1. Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:\n\n   1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;\n   2. Bipolar Disorder;\n2. Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:\n\n   1. Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;\n   2. Eating disorder;\n   3. Substance use disorders (excluding nicotine);\n   4. Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;\n   5. Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;\n3. The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;\n4. The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;\n5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:\n\n   1. At Screening, the patient scores \"yes\" on Suicidal Ideation Items 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 4 or 5 since the Screening Visit;\n   2. At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;\n   3. At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or\n   4. The patient is considered to be in imminent danger to him\u002Fherself or others.\n6. The patient has a first MDE at age 60 years or older.","65 Years",{"count":220,"type":22},470,[135],"This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.",[224],"Major Depressive Disorder",[226],"Adjunctive MDD Therapy","2025-06-30",{"date":229,"type":33},"2025-07-01",{"date":231,"type":33},"2023-05-02",{"date":233,"type":22},"2026-10",{"name":39,"class":40},{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},"100551632","phase-3-study-of-lumateperone-in-the-treatment-of-patients-with-bipolar-mania-100551632","NCT06462612","Study of Lumateperone in the Treatment of Patients With Bipolar Mania","A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)","Inclusion Criteria:\n\n1. Able to provide written informed consent before the initiation of any study specific procedures;\n2. Male or female inpatient, between the ages of 18 and 75 years, inclusive;\n3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);\n4. YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive\u002Faggressive behavior at Screening and Baseline;\n5. Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not \\> 14 days before Screening. Hospital admission must be a result of the current manic episode.\n\nExclusion Criteria:\n\n1. Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:\n\n   1. Schizophrenia, schizoaffective disorder, or other psychotic disorders;\n   2. Dementia or other cognitive disorders;\n   3. Intellectual disability;\n   4. Moderate or severe substance use disorder (excluding for nicotine);\n2. Experiencing first manic episode;\n3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his\u002Fher participation in the study or\n\n   1. At Screening, the patient scores \"yes\" on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or\n   2. At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or\n   3. At Baseline, the patient scores \"yes\" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or\n   4. At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or\n   5. Considered to be an imminent danger to himself\u002Fherself or others.","75 Years",{"count":244,"type":22},350,[135],"This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).",[248],"Bipolar Disorder, Manic","2025-06-27",{"date":229,"type":33},{"date":252,"type":33},"2024-07-17",{"date":254,"type":22},"2026-06",{"name":39,"class":40},35,{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":242,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":246,"conditions":264,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":21},"100551630","phase-3-study-of-lumateperone-in-the-acute-treatment-of-patients-with-bipolar-mania-100551630","NCT06462586","Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania",{"count":244,"type":22},[135],[248],{"date":229,"type":33},{"date":267,"type":33},"2024-06-19",{"date":269,"type":22},"2026-04",{"name":39,"class":40},{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":130,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},"100558959","phase-1-safety-tolerability-and-pharmacokinetics-of-lumateperone-in-pediatric-patients-with-autism-spectrum-disorder-100558959","NCT06557902","Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder","An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Male or female patients between 5 to less than 13 years of age\n* Primary clinical diagnosis of ASD with symptoms of irritability\n* ABC-I subscale score of ≥12 at Screening\n* CGI-S score of ≥3 at Screening\n* Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening\n* Ability to swallow capsules\n\nExclusion Criteria:\n\n* Has a primary psychiatric diagnosis other than ASD\n* Reports suicidal ideation (Type 3, 4 or 5 on the Baseline\u002FScreening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and\u002For the Investigator assesses the patient to be a safety risk to him\u002Fherself or others\n* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables\n* History of a clinically significant cardiac disorder and\u002For abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) \\> 460 msec at Screening\n* Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening\n* Has a history of uncontrolled\u002Fdisruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures","12 Years",{"count":280,"type":22},26,[25],"Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.",[140],"2024-08-14",{"date":286,"type":33},"2024-08-16",{"date":288,"type":33},"2024-05-10",{"date":290,"type":22},"2026-07-31",{"name":39,"class":40},8,""]