[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Karuna Therapeutics, Inc., a Bristol Myers Squibb company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":213},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,65,94,112,132,158,187],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100478545","phase-3-a-study-to-assess-efficacy-and-safety-of-karxt-for-the-treatment-of-psychosis-associated-with-alzheimers-disease-adept-1-100478545",false,"NCT05511363","A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease","Inclusion Criteria:\n\n* Is aged 55 to 90 years, inclusive, at Screening\n* Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met.\n\n  i) The subject's legally acceptable representative must provide informed consent; ii) The subject must provide assent or similar where permitted per local law\u002Fregulation and as approved by the IRB\u002FIEC.\n* Meets clinical criteria for possible or probable Alzheimer's Disease\n* Has a Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome. If not available, a non-contrast brain MRI or non-contrast head CT must be done during screening.\n* Living at the same location for a minimum of 4 weeks before Screening, with the intention of living at the same location throughout the study.\n* Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified caregiver or study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant (ie, ≥ approximately 7 hours per week) on a regular basis to reliably provide accurate information regarding the participant's cognitive, behavioral, and functional status, and is willing to:\n\n  i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures; iii) Participate in the study assessments and provide informed consent to participate in the study.\n* History of psychotic symptoms (meeting International Psychogeriatric Association \\[IPA\\] criteria) for at least 2 months prior to Screening.\n* Clinical Global Impressions-Severity (CGI-S) scale with a score ≥4 (moderate) at Screening and Baseline. CGI-S requires the assessor to consider aspects of the psychosis prior to providing a global assessment of severity. These aspects include hallucinations and delusions.\n* Subjects are required to meet at least one of the following criteria at Screening and Baseline:\n\n  i) Moderate to severe delusions, defined as Neuropsychiatric Inventory-Clinician (NPI-C): Delusions domain score of ≥2 on two of the eight items OR; ii) Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on two of the seven items.\n* Mini-Mental State Examination (MMSE) score of 6 to 24, inclusive, at Screening\n* If the subject is taking a cholinesterase inhibitor and\u002For memantine, they must have been on a stable dose for 6 weeks prior to Screening and be willing to maintain a stable dose for the duration of the study.\n* Participant is willing and able to attend the study visit for the study duration, follow instructions, and comply with the protocol requirements\n* BMI must be within 16 to 40 kg\u002Fm2 and participants with a BMI of 16 to \\\u003C18 kg\u002Fm2 must have a body weight ≥40 kg.\n* A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding. Individual of childbearing potential (IOCBP) must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of IMP.\n\nExclusion Criteria:\n\n* Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia\n* History of major depressive episode with psychotic features during the 12 months prior to Screening\n* History of a diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder\n* Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular or oncologic disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results\n* Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of \\\u003C50 mL\u002Fmin\n* History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke\n* History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope\n* Any of the following:\n\n  i) New York Heart Association Class 2 congestive heart failure; ii) Grade 2 or greater angina pectoris; iii) Sustained ventricular tachycardia; iv) Ventricular fibrillation; v) Torsade de pointes; vi) Implantable cardiac defibrillator.\n* Myocardial infarction within the 6 months prior to Screening\n* Personal or family history of symptoms of long QT syndrome as evaluated by the investigator\n* Human immunodeficiency virus, cirrhosis, biliary duct abnormalities, active biliary disease, hepatobiliary carcinoma, and\u002For active hepatic viral infections as indicated by medical history or liver function tests results\n* History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the investigator\n* Participants with any of the following:\n\n  i) History of bladder stones; ii) History of recurrent urinary tract infections; iii) For male participants:\n  1. Serum prostate specific antigen (PSA) \\> 10 ng\u002FmL at Screening\n  2. An IPSS of 5 (almost always) on items 1, 3, 5, or 6\n  3. A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9\n* History of obstructive gastrointestinal disorder, gastric retention, irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months\n* Risk of suicidal behavior during the study as determined by clinical assessment and\u002F or C-SSRS\n* Clinically significant abnormal finding on the physical examination, electrocardiogram, or clinical laboratory results at Screening\n* Urine toxicology screen is positive substances other than cannabis or benzodiazepines (both cannabis and short-or medium-acting benzodiazepines are allowed in limited quantities during the study) unless approval has been given by the Medical Monitor\n* Currently receiving monoamine oxidase inhibitors, anticonvulsants (e.g., lamotrigine, divalproex), mood stabilizers (eg, lithium) tricyclic antidepressants (e.g., imipramine, desipramine), or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam) and unable to complete the washout:\n\n  i) Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening may be permitted; ii) Mirtazapine or trazodone may be used if started at least 8 weeks prior to Screening. If needed, an extension (up to two weeks) of the Screening Period may be allowed with approval of the Sponsor\u002FMedical Monitor.\n* If, in the opinion of the Investigator and\u002For Sponsor\u002FMedical Monitor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator and\u002For Sponsor\u002F Medical Monitor, may compromise the safety of the subject or affect his\u002Fher ability to adhere to the protocol visit schedule or fulfill visit requirements\n* Positive test for coronavirus (COVID-19) within 2 weeks before or at Screening; antigen or PCR local testing can be done at the discretion of the Investigator\n* Unable to taper and discontinue a concomitant medication that would preclude participation in the study\n* Prior exposure to KarXT\n* Experienced any significant adverse events due to trospium, including a known hypersensitivity to trospium\n* Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the past year\n* Other protocol-defined Inclusion\u002FExclusion criteria apply","ALL","55 Years","90 Years",{"count":20,"type":21},410,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease.\n\nThe primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.",[27],"Psychosis Associated With Alzheimer's Disease","RECRUITING","2026-08-13",{"date":31,"type":32},"2026-08-17","ACTUAL",{"date":34,"type":32},"2022-08-23",{"date":36,"type":21},"2026-10-05",{"name":38,"class":39},"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","INDUSTRY",129,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100625574","phase-3-a-study-to-evaluate-the-long-term-safety-and-tolerability-of-karxt-and-karx-ec-for-the-treatment-of-schizophrenia-and-autism-related-irritability-in-adolescents-respectively-100625574","NCT07424404","A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively","A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and 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 completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.\n\nExclusion Criteria\n\n* Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of \"Yes\" on Questions 4 or 5 on the suicidal ideation section of the \"Since Last Visit\" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.\n* Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.\n* Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","5 Years","17 Years",{"count":51,"type":21},400,[24],"The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively",[55,56],"Schizophrenia","Autism-Related Irritability","2026-08-12",{"date":29,"type":32},{"date":60,"type":32},"2026-04-07",{"date":62,"type":21},"2030-03-08",{"name":38,"class":39},95,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100561102","phase-3-a-study-to-evaluate-karxt-as-a-treatment-for-psychosis-associated-with-alzheimers-disease-adept-4-100561102","NCT06585787","A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease","Inclusion Criteria\n\n* Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).\n* Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.\n* Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.\n* Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).\n\nExclusion Criteria\n\n\\- Patients will not be able to participate if they have:\n\ni) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.\n\nii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.\n\niii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.\n\n\\* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":73,"type":21},406,[24],"The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.",[77],"Alzheimer Disease",[79,80,81,82,83,84],"Alzheimer's Disease","AD","ADEPT4","ADEPT-4","KarXT","Psychosis","2026-07-29",{"date":87,"type":32},"2026-07-30",{"date":89,"type":32},"2024-09-26",{"date":91,"type":21},"2026-12-22",{"name":38,"class":39},292,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":70,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100525783","phase-3-a-study-to-assess-efficacy-and-safety-of-karxt-for-the-treatment-of-psychosis-associated-with-alzheimers-disease-adept-2-100525783","NCT06126224","A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)","Key Inclusion Criteria:\n\n1. Is a male or female aged 55 to 90 years, inclusive, at Screening.\n2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.\n3. Meets clinical criteria for Possible AD or Probable AD.\n4. Must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening.\n5. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.\n6. Have an identified study partner who should have daily contact (approximately 10 hours a week or more).\n7. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.\n8. CGI-S scale with a score ≥ 4 at Screening and Baseline.\n9. AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline:\n\n   1. Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR\n   2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items\n10. MMSE score of 8 to 22, inclusive, at Screening.\n\nKey Exclusion Criteria:\n\n1. Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.\n2. History of major depressive episode with psychotic features during the 12 months prior to Screening.\n3. History of bipolar disorder, schizophrenia, or schizoaffective disorder.\n4. Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.\n5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.\n6. Prior exposure to KarXT.\n7. History of hypersensitivity to KarXT excipients or trospium chloride.\n8. Experienced any significant adverse events (AEs) due to trospium.\n9. Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the 12 months prior to Screening.\n10. Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":101,"type":21},500,[24],"This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.\n\nThe primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.",[27],{"date":87,"type":32},{"date":107,"type":32},"2023-08-28",{"date":109,"type":21},"2026-12-09",{"name":38,"class":39},154,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100514626","phase-3-open-label-extension-study-to-assess-the-long-term-safety-and-tolerability-of-karxt-in-subjects-with-psychosis-associated-with-alzheimers-disease-adept-3-100514626","NCT05980949","Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)","Inclusion Criteria:\n\n* Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-0056. This Inclusion criterion is not applicable for Protocol Amendment 07 or later versions.\n* Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are performed. If the subject is deemed not competent to provide IC, both the following requirements for consent must be met:\n\n  1. The subject's legally acceptable representative (LAR) must provide IC\n  2. The subject must provide informed assent\n* Must have stable living environment. At entry into this study, or any time during the study, if a subject needs to relocate from home, a residential assisted-living facility, or other stable location to a nursing home facility, the Sponsor\u002FMedical Monitor must approve the subject's participation in the study.\n\nExclusion Criteria:\n\n* Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.\n* Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study KAR-031 (Visit 19), Study KAR-032 (Visit 12), Study CN012-0056 (Visit 12) that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.\n* Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":119,"type":21},1000,[24],"This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.",[27],"2026-07-02",{"date":125,"type":32},"2026-07-06",{"date":127,"type":32},"2023-07-11",{"date":129,"type":21},"2027-09-07",{"name":38,"class":39},429,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100646690","phase-3-relapse-prevention-trial-evaluating-karxt-treatment-in-schizophrenia-100646690","NCT07686263","Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia","A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia","Inclusion Criteria\n\n* Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.\n* Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.\n* Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.\n* Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:\n\n  1. Item 1 (P1; delusions)\n  2. Item 2 (P2; conceptual disorganization)\n  3. Item 3 (P3; hallucinatory behavior)\n  4. Item 6 (P6; suspiciousness\u002Fpersecution)\n* Participant must have a CGI-S score of ≥ 4 at screening and Day -1\n* Participant must have a BMI ≥ 18 and ≤ 40 kg\u002Fm2.\n\nExclusion Criteria\n\n* Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening\n* Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.\n* Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and\u002For Columbia-suicide Severity Rating Scale (C-SSRS).\n* Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.\n* Participant must not have a history of treatment resistance to schizophrenia medications\n* Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","18 Years","65 Years",{"count":142,"type":21},472,[24],"The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia",[55],[83,147],"Cobenfy","NOT_YET_RECRUITING","2026-06-30",{"date":151,"type":32},"2026-07-07",{"date":153,"type":21},"2026-09-03",{"date":155,"type":21},"2029-03-03",{"name":38,"class":39},61,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":165,"sex":16,"minAge":139,"maxAge":140,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100645311","phase-4-study-to-assess-safety-and-tolerability-of-karxt-with-administration-of-antiemetics-in-healthy-volunteers-100645311","NCT07681076","Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers","A Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline\u002FTrospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers","Inclusion Criteria:\n\n* Participants must be healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.\n* Participants must be willing and able to be confined to an inpatient setting for a 3-week duration, follow instructions, and comply with the protocol requirements.\n* Participants must have BMI ≥ 18 and ≤ 40 kg\u002Fm2.\n* Individuals of childbearing potential (IOCBP) must be willing and able to adhere to the contraception guidelines.\n\nExclusion Criteria:\n\n* Participants must not have history or presence of clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gastrointestinal (\\[GI\\] eg, obstructive disorders \\[including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis\\], active biliary disease \\[including symptomatic gallstones\\]), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* Participants must not have history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 12 months or a positive urine drug screen (UDS) for a substance other than cannabis at screening or baseline.\n* Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.\n* Participants must not have active biliary disease (eg, symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the medical monitor.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",true,{"count":167,"type":21},225,[169],"PHASE4","This study looks at how to reduce nausea and vomiting in people taking KarXT which is used to treat mental health conditions like schizophrenia. KarXT can cause stomach-related side effects, especially in the first couple of weeks. In this study, healthy volunteers will take KarXT along with anti-nausea medication, either regularly (to prevent symptoms) or as needed.\n\nThe goal is to see how well these strategies help reduce nausea and vomiting and how safe the combination is. The results will help doctors better manage side effects and make treatment more comfortable for patients starting KarXT.",[172],"Healthy Volunteers",[174,83,175,176,177,178,179],"BMS-986510","Xanomeline\u002FTrospium","Antiemetics","Nausea","Vomiting","Gastrointestinal side effects","2026-06-26",{"date":123,"type":32},{"date":183,"type":21},"2026-08-03",{"date":185,"type":21},"2026-11-30",{"name":38,"class":39},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":165,"sex":16,"minAge":139,"maxAge":140,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100608658","phase-1-a-study-to-evaluate-the-effects-of-cyp2d6-phenotypes-on-the-pharmacokinetics-of-xanomeline-following-karxt-administration-in-healthy-adult-participants-100608658","NCT07204418","A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants","A Phase 1, 4-part, Open-label Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants","Inclusion Criteria:\n\n* Participant must be healthy male and female (INOCBP) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs (VS), and clinical laboratory determinations.\n* Participant must be a normal\u002Fextensive, intermediate, poor, or ultrarapid CYP2D6 metabolizer.\n* Participant must have body mass index (BMI) of 18.0 to 32.0 kg\u002Fm2, inclusive.\n\nExclusion Criteria:\n\n* Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":195,"type":21},56,[197],"PHASE1","The purpose of this study is to evaluate the pharmacokinetics (PK) of xanomeline following administration of KarXT in CYP2D6 normal\u002Fextensive, intermediate, poor, and ultrarapid metabolizers.",[172],[201,202,174,83,147,203],"Healthy volunteer","Pharmacokinetics","CYP2D6","2026-02-17",{"date":206,"type":32},"2026-02-19",{"date":208,"type":32},"2025-10-13",{"date":210,"type":21},"2026-12-03",{"name":38,"class":39},3,""]