[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tardive-dyskinesia-td\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tardive-dyskinesia-td":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100648085","a-computer-assisted-tool-for-objective-assessment-of-extrapyramidal-symptoms-100648085",false,"NCT07715994","A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms","Development of an Objective Quantitative Assessment and Computer-Assisted Diagnostic Tool for Extrapyramidal Symptoms","Inclusion Criteria\n\nA. Control Group\n\n1. Aged 18 to 80 years, with no restriction on sex.\n2. No current or past history of a psychiatric disorder meeting ICD-10 or DSM-5 criteria.\n3. No current or past history of central nervous system disease, such as primary Parkinson's disease or epilepsy, and no severe physical illness.\n4. No use within the 3 months before screening of medications that may cause extrapyramidal symptoms, such as antipsychotics or certain antiemetic medications.\n5. Sufficient visual, auditory, and cognitive ability to understand and cooperate with the standardized device-side assessment task sequence.\n6. Full understanding of the purpose and exploratory research nature of the study, voluntary participation, and provision of written informed consent.\n\nB. EPS Disease Group\n\n1. Aged 18 to 80 years, with no restriction on sex.\n2. Diagnosis of schizophrenia or a related psychotic disorder according to ICD-10 criteria.\n3. Regular treatment with one or more antipsychotic medications for at least 4 weeks.\n4. Clinically confirmed antipsychotic-induced extrapyramidal symptoms meeting at least one of the following criteria:\n\n   1. Drug-induced parkinsonism: a total score of 2 or higher on Items 1, 2, 3, 4, 5, and 9 of the Simpson-Angus Scale (SAS).\n   2. Akathisia: a score of 2 or higher on the Global Clinical Assessment item of the Barnes Akathisia Rating Scale (BARS).\n   3. Tardive dyskinesia: a score of 3 or higher on any one of Items 1 through 7 of the Abnormal Involuntary Movement Scale (AIMS), or a score of 2 or higher on any two of these items.\n5. Sufficient visual, auditory, and cognitive ability to understand and cooperate with the standardized device-side assessment task sequence.\n6. Full understanding of the purpose and exploratory research nature of the study, voluntary participation, and provision of written informed consent by the participant or, where applicable, the participant's legal guardian.\n\nExclusion Criteria\n\nThe following exclusion criteria apply to both groups:\n\n1. Primary neurological or organic movement disorders that may affect the assessment results, such as primary Parkinson's disease, Huntington's disease, Wilson's disease, or sequelae of stroke.\n2. Severe musculoskeletal disease, recent fracture, limb disability, or other physical conditions that prevent completion of the required assessment tasks.\n3. Acute exacerbation of psychiatric symptoms with severe agitation, impulsivity, stupor, or severe cognitive impairment that prevents safe and adequate cooperation with the assessment.\n4. Severe deformity of the face or tested limbs, large dark-colored tattoos, or severe non-removable occlusion that may substantially interfere with computer-vision-based assessment.\n5. Poorly fitting removable dentures or frequent compensatory oral movements that may interfere with objective assessment of orofacial movements.\n6. Any condition that, in the investigator's judgment, may affect participant safety, substantially compromise data quality, or make the individual unsuitable for participation.",true,"ALL","18 Years","80 Years",{"count":21,"type":22},180,"ESTIMATED","OBSERVATIONAL","This prospective, single-center observational study aims to develop and validate a computer-assisted tool for the objective quantitative assessment of extrapyramidal symptoms (EPS).\n\nThe study will enroll 180 participants, including 90 healthy controls and 90 participants with clinically confirmed antipsychotic-induced EPS. The healthy control group will provide reference data on normal movement, while the EPS disease group will provide data on abnormal movements associated with drug-induced parkinsonism, akathisia, or tardive dyskinesia.\n\nEach participant will complete one study visit lasting approximately 60 minutes. During the visit, a trained psychiatrist will assess EPS using the Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS). Participants will also complete standardized movement tasks while a non-contact computer vision system records and analyzes movement features. The device-based assessment will be repeated after a short rest to evaluate the stability of the measurements.\n\nData collected earlier in the study will be used to develop and optimize the assessment tool. After the algorithm is finalized and locked, data from subsequently enrolled participants will be used for independent validation. The study will evaluate how closely the tool's results agree with clinician assessments, as well as its ability to identify EPS, produce stable repeated measurements, and operate feasibly and safely in a clinical setting.\n\nThis is an observational study. The study does not assign treatment, change participants' medications, or use the investigational tool to make treatment decisions.",[26,27,28,29],"Extrapyramidal Symptoms","Drug-induced Parkinsonism","Akathisia, Drug-Induced","Tardive Dyskinesia (TD)",[31,32,33,34],"Antipsychotic-Induced Extrapyramidal Symptoms","Objective Quantitative Assessment","Computer-Assisted Diagnosis","Computer Vision","NOT_YET_RECRUITING","2026-07-20",{"date":38,"type":39},"2026-07-21","ACTUAL",{"date":41,"type":22},"2026-07",{"date":43,"type":22},"2027-04",{"name":45,"class":46},"Shanghai Mental Health Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100572330","phase-1-safety-and-efficacy-of-lpm3770164-sustained-release-tablets-in-patients-with-tardive-dyskinesia-100572330","NCT06731868","Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia","A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Characteristics of Multiple Doses of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia","Inclusion Criteria:\n\n1. Subject who voluntarily participate in and sign the informed consent form;\n2. Male or female subjects aged ≥ 18 years and \\\u003C 65 years;\n3. Body mass index (BMI) 18.5 \\~ 38.0 kg\u002Fm2 (including boundary value);\n4. Subjects with a past diagnosis of schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders based on medical history, and stable for at least 1 month;\n5. Subjects who have been diagnosed with medication-induced TD, and whose symptoms have lasted for at least 3 months according to the DSM-5; and TD is assessed as moderate or severe (AIMS Item 8 score ≥3);\n6. Medications for schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders and extrapyramidal reactions should be kept dose stable for at least 1 month (benzodiazepines should stable at least 14 days, Long-acting injection should stable for at least 3 months);\n7. Females of childbearing potential have a negative pregnancy test. Male and female patients of childbearing potential and their spouses\u002Fpartners agree to not plan to become pregnant (including the plan for sperm and egg donation) and to use effective contraceptive measures throughout the study and for at least 1 month after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Has comorbid abnormal involuntary movement(s) that is more prominent than TD as judged by the investigator;\n2. Has Simpson-Angus Scale (SAS) score≥ 3 on two or more items other than items 8 and 10;\n3. Currently in the acute phase of mental disorder or severe psychiatric symptoms, unable to cooperate with the treatment and assessment, as judged by the investigator;\n4. Has a history of suicide attempt or Question 4 or Question 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) as \"Yes\" within the past 6 months;\n5. Has a history of neuroleptic-related malignant syndrome;\n6. Has diagnosed with malignant tumor within 3 years before randomization;\n7. Has a history of long QT syndrome or tachyarrhythmia within 3 years before randomization;\n8. Electrocardiogram QTcF \\> 450 ms, or other clinically significant ECG findings in the opinion of the investigator;\n9. Patients with significant abnormal liver and kidney function indicators, meeting any of the following criteria: serum creatinine \\> 1.5 × upper limit of normal (ULN); serum alanine transaminase (ALT) or aspartate transaminase (AST) \\> 2.5 × ULN; total bilirubin \\> 1.5 × ULN;\n10. Has active, severe and unstable cerebrovascular, liver, kidney, endocrine, cardiovascular, gastrointestinal, respiratory, or metabolic disorders within 30 days prior to screening, in the judgment of the investigator, would interfere with the patient's ability to participate in the trial;\n11. Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as but not limited to history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding;\n12. Has a known history of allergy to any component of the investigational product or similar drugs, or allergic constitution;\n13. Has a positive human immunodeficiency virus antibody (HIV-Ab) and syphilis;\n14. Has a positive urine drug screen;\n15. Patients diagnosed with substance-related and addictive disorders (except tobacco- or caffeine-related disorders) within 6 months prior to the screening visit;\n16. Has participated in any clinical trials of drugs (excluding vitamins and minerals) within 3 months prior to the screening visit;\n17. Patients who previously received deep brain stimulation (DBS), or received electroconvulsive therapy (ECT) or other physical therapy within 1 month prior to the screening visit;\n18. Patients who use of strong inducers or inhibitors of CYP3A4 within 14 days or 5 half-lives, whichever is longer, prior to randomization;\n19. Known history of a nonresponder to tetrabenazine, deutetrabenazinen, or valbenazine for the treatment of TD;\n20. Patients who have been injected with botulinum toxin in the past 3 months;\n21. Patients who have used the prohibited drugs in the past 1 month;\n22. Nursing mothers;\n23. For patients with schizophrenia and schizoaffective disorder, has a total PANSS score \\> 80, and\u002For a total CDSS score \\> 10;\n24. For patients with bipolar and related disorders or depressive disorders, has a history of rapid cycling, or a total MADRS score \\> 22, or a total YMRS score \\> 12;\n25. Other conditions judged by the investigator as unsuitable for participating in the trial.","64 Years",{"count":57,"type":22},120,"INTERVENTIONAL",[60,61],"PHASE1","PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled parallel-group trial to evaluate the safety, tolerability, preliminary efficacy and PK characteristics of multiple doses of LPM3770164 sustained-release tablets in TD patients.",[29],"RECRUITING","2025-01-20",{"date":67,"type":39},"2025-01-22",{"date":69,"type":39},"2025-01-14",{"date":71,"type":22},"2025-10-31",{"name":73,"class":74},"Luye Pharma Group Ltd.","INDUSTRY"]