[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tardive-dyskinesia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tardive-dyskinesia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,71,109,133,156],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100621041","phase-2-efficacy-safety-and-tolerability-of-nbi-1065890-versus-placebo-in-adults-with-tardive-dyskinesia-100621041",false,"NCT07365462","Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1065890 in Adult Participants With Tardive Dyskinesia","Key Inclusion Criteria:\n\n* Medically confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for at least 3 months prior to screening.\n* Medically confirmed diagnosis of neuroleptic-induced TD as defined in the DSM-5 for at least 3 months prior to screening.\n* Moderate or severe TD (AIMS Item 8, severity of abnormal movement overall) as assessed by a blinded, external AIMS video reviewer using a video recording of the participant's AIMS assessment administered at the clinical site by a blinded, certified site AIMS rater. The AIMS dyskinesia total score (sum of Items 1 to 7) must be ≥6 as assessed by the blinded, external AIMS video reviewer.\n\nKey Exclusion Criteria:\n\n* Comorbid parkinsonism (drug-induced or otherwise) or more than a minimal level of extrapyramidal signs\u002Fsymptoms, as documented by a score on the Modified Simpson-Angus Scale (mSAS) (excluding Items 8 and 10) \\>6 at screening or Day -1 (baseline) or a score \\>3 in any one item (excluding Items 8 and 10).\n* Barnes Akathisia Rating Scale (BARS) global clinical assessment score ≥2 at screening or Day -1.\n* Brief Psychiatric Rating Scale (BPRS) total score ≥50 at screening or Day -1.\n* Hospitalized for schizophrenia, schizoaffective disorder, bipolar disorder, or MDD within 6 months of screening.\n* Participant has an unstable medical condition or unstable chronic disease.\n* Any known history of neuroleptic malignant syndrome (NMS).\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.","ALL","18 Years","75 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The primary objective of this study is to evaluate the efficacy of NBI-1065890 compared with placebo for the treatment of tardive dyskinesia (TD) in adult participants.",[27],"Tardive Dyskinesia",[27,29],"NBI-1065890","RECRUITING","2026-06-19",{"date":33,"type":34},"2026-06-23","ACTUAL",{"date":36,"type":34},"2026-02-06",{"date":38,"type":21},"2027-03",{"name":40,"class":41},"Neurocrine Biosciences","INDUSTRY",18,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100601024","phase-4-a-study-to-evaluate-the-effectiveness-of-valbenazine-in-adult-participants-with-tardive-dyskinesia-td-who-remain-symptomatic-while-receiving-or-after-stopping-a-vesicular-monoamine-transporter-2-vmat2-inhibitor-100601024","NCT07105111","A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor","A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor","Key Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder\n* Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening\n\nKey Exclusion Criteria:\n\n* Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD\n* Diagnosis of moderate or severe substance use disorder in the last 6 months\n* History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment",{"count":51,"type":21},50,[53],"PHASE4","This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.",[56,57,58,59,27],"Schizophrenia","Schizoaffective Disorder","Bipolar Disorder","Major Depressive Disorder",[61],"Valbenazine","2026-06-15",{"date":64,"type":34},"2026-06-16",{"date":66,"type":34},"2025-08-29",{"date":68,"type":21},"2027-01",{"name":40,"class":41},22,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100592728","phase-4-deutetrabenazine-treatment-for-tardive-dyskinesia-in-intellectualdevelopmental-disabilities-100592728","NCT06997198","Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual\u002FDevelopmental Disabilities","Identification, Assessment, and Treatment of Tardive Dyskinesia With Deutetrabenazine in Adults With Intellectual\u002FDevelopmental Disabilities and Co-occurring Psychiatric and\u002For Behavioral Disorders","TD-AIDD","Participant Inclusion Criteria:\n\n* Diagnosis of IDD (IQ \\\u003C 70; social\u002Fadaptive dysfunction, onset \\\u003C age 22) as per DSM-5\n* Clinical diagnosis of Tardive Dyskinesia (TD) per DSM-5 for at least 3 months before study inclusion (presence of movement disorder for at least 3 months, in absence of previous formal diagnosis of TD).\n* Eligible to receive deutetrabenazine, according to current product labeling Stable doses of all psychotropic medications for minimum of three months before study inclusion\n* Willing to remain on stable doses of all psychotropics for 24 weeks of study. If female of childbearing age, practicing acceptable form of birth control throughout study duration.\n* Subject able to comply with scheduled visits and assessments\n* Consent of subject, or legally authorized representative to study protocol.\n\nCaregiver Inclusion Criteria:\n\n* Able to understand and answer questionnaires\n* Able to comply with scheduled visits\n* Ability to be primary Caregiver for 24 weeks of study\n\nParticipant Exclusion Criteria:\n\n* Previous treatment with a VMAT2 inhibitor (tetrabenazine, valbenazine, or deutetrabenazine).\n* Treatment with any investigational drug in the 30 days prior to study entry.\n* Currently taking a strong CYP2D6 inhibitor such as fluoxetine, paroxetine, quinidine, bupropion. Current treatment with strong anticholinergic agents, monoamine oxidase inhibitors, metoclopramide, dopamine agonists, L-DOPA, or stimulants within past 30 days, or botulinum toxin within the past 3 months.\n* Any unstable medical condition in the 60 days prior to study entry.\n* Pregnant or breast-feeding\n* Current or recent hepatic impairment\n* History of neuroleptic malignant syndrome\n* History of long QTc on electrocardiogram, bundle branch block (BBB), atrioventricular block, serious cardiac arrhythmia, or heart failure.\n\nQTc on EKG \\> 450 msec (Fredericia formula) on EKG within 3 months prior to study entry.\n\n* History of substance abuse or dependence in the 3 months prior to study entry.\n* Significant risk of suicide or dangerous aggression to others at time of or 3 months prior to study entry.\n* Inability to take study medications\n\nCaregiver Exclusion Criteria:\n\n* Unable to complete questionnaires\n* Unable to comply with scheduled visits\n* Will not be a primary Caregiver for the 24 weeks of the study","89 Years",{"count":81,"type":21},25,[53],"The primary goal of this study is to investigate the efficacy of deutetrabenazine treatment of TD in this previously untreated patient population. Compare movement disorder deutetrabenazine treatment response in persons with IDD to response seen in patients without IDD treated with deutetrabenazine in other treatment settings (per literature review). Compare global deutetrabenazine treatment response with validated instruments.\n\nIn addition, we plan to:\n\n* Assess the safety of deutetrabenazine in the treatment of TD in persons with IDD.\n* Assess change in Activities of Daily Living (ADLs) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated ADL instrument.\n* Assess change in Quality of Life (QOL) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated QOL instrument.\n* Assess caregiver burden with a validated caregiver burden instrument.\n\nIn this study, 25 participants with IDD and TD will undergo Deutetrabenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks.\n\nThis study does not include a comparison group. Therefore, researchers will compare the response of the study participants to deutetrabenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication. This will be an open-label, Phase 4 study.",[27,85,86],"Intellectual Disability","Developmental Disabilities",[88,89,90,91,92,93,94,95,96],"movement disorders","antipsychotic medication adverse effects","Abnormal Involuntary Movement Scale","quality of life","adaptive behavior","caregiver burden","deutetrabenazine","selective vesicular monoamine transporter 2 inhibitor","VMAT2 inhibitor","NOT_YET_RECRUITING","2026-04-03",{"date":100,"type":34},"2026-04-09",{"date":102,"type":21},"2026-05-01",{"date":104,"type":21},"2027-10-01",{"name":106,"class":107},"University Hospitals Cleveland Medical Center","OTHER",1,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":108},"100606312","single-center-double-blind-randomized-placebo-controlled-study-on-efficacy-and-safety-of-rtms-with-precise-localization-in-relieving-motor-symptoms-of-td-100606312","NCT07173920","Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD","A Single-Center, Double-Blind, Randomized, Placebo-Controlled Clinical Study on the Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation (rTMS) Under Precise Localization for Relieving Motor Symptoms of Tardive Dyskinesia","Inclusion Criteria:\n\n* (1) Age between 18 and 65 years; (2) Patients whose diagnosis is consistent with the tardive dyskinesia (TD) diagnostic criteria defined by the Schooler-Kane criteria, with a disease duration of at least 3 months before screening, and a history of treatment with dopamine receptor antagonists for at least 3 months (a minimum of 1 month for patients aged ≥ 60 years); other diseases that may cause involuntary movements are excluded\n\nExclusion Criteria:(1) Diagnosed with movement disorders other than tardive dyskinesia (TD); (2) A history of focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or higher) identified on previous head MRI\u002FCT; (3) A personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant medications for seizure management; (4) Presence of metallic medical devices in the body (e.g., cardiac pacemakers, cochlear implants), other metallic foreign bodies, or any electronic devices implanted in the body; or having other contraindications to repetitive Transcranial Magnetic Stimulation (rTMS); (5) Presence of contraindications to MRI scanning, such as having metallic implants in the body or claustrophobia\n\n\\-","65 Years",{"count":118,"type":21},62,[120],"NA","\\# Brief Summary (English Version) Tardive Dyskinesia (TD) is a hyperkinetic movement disorder induced by long-term use of dopamine receptor blockers and related drugs. Characterized by involuntary spasms or choreiform movements involving the tongue, lower face, jaw, and limbs (persisting for at least several weeks), TD causes irreversible neurological damage that persists even after discontinuing the causative drugs, significantly impairing patients' functional outcomes.\n\nrTMS is a non-invasive neuromodulation technique: time-varying currents in a coil generate magnetic fields that penetrate the scalp and skull to act on brain neurons, inducing depolarization, neural network activation, neurotransmitter release, metabolic changes, and gene expression, thereby producing physiological effects \\[9\\]. In recent years, rTMS has gained attention for treating movement disorders (e.g., Parkinson's disease, motor neuron disease, dystonia, essential tremor, Huntington's disease) due to its non-invasiveness, high safety, and repeatability. Studies have reported that rTMS can significantly improve motor symptoms in TD patients \\[10, 11\\]; however, existing research is limited by small sample sizes, conventional treatment parameters, large inter-individual variability, and unclear long-term efficacy.\n\nrTMS efficacy in TD is strongly influenced by parameters including stimulation targets, localization methods, sequences, and cycles. Optical navigation (using personalized MRI) is the most accurate and yields the best therapeutic effects, compared to manual localization or positioning caps . Regarding stimulation sequences, 1Hz and 20Hz rTMS have shown efficacy but with short-lived effects. Continuous theta-Burst Stimulation (cTBS)-a specialized rTMS mode that delivers rapid pulse trains mimicking endogenous theta-wave bursts-provides higher therapeutic doses in less time, enabling more durable efficacy and effectively reducing motor cortex excitability .\n\nTherefore, this study aims to investigate the effect of cTBS (under precise localization) on improving motor symptoms in patients with TD.",[27,123],"Repetitive Transcranial Magnetic Stimulation","2025-11-27",{"date":126,"type":34},"2025-12-05",{"date":128,"type":34},"2025-09-08",{"date":130,"type":21},"2028-12-30",{"name":132,"class":107},"Peking University Sixth Hospital",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":108},"100532892","studying-patterns-in-patient-engagement-among-tardive-dyskinesia-patients-100532892","NCT06218719","Studying Patterns in Patient Engagement Among Tardive Dyskinesia Patients","Examining Engagement Patterns: An Observational Exploration About Tardive Dyskinesia Clinical Trials","Inclusion Criteria:\n\n* Diagnosis of tardive dyskinesia\n* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed\n* No prior treatment for tardive dyskinesia\n\nExclusion Criteria:\n\n* Enrolled in another research study\n* Inability to provide written informed consent\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial",{"count":141,"type":21},500,"OBSERVATIONAL","The statistical analysis of the collected data aims to reveal the many factors that influence patient involvement in clinical trials. Findings will be disseminated through conferences and scholarly papers to benefit all parties participating in clinical trials.\n\nThese findings will help to shape the design of future clinical trials for people with tardive dyskinesia, as well as enhance recruiting techniques and retention rates.",[27],[146],"tardive dyskinesia","2024-01-12",{"date":149,"type":34},"2024-01-23",{"date":151,"type":21},"2025-02",{"date":153,"type":21},"2027-02",{"name":155,"class":41},"Power Life Sciences Inc.",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":108},"100323751","phase-4-smoking-cessation-with-varenicline-in-schizophrenia-antipsychotic-induced-neurological-symptoms-as-correlates-100323751","NCT03495024","Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates","Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response","Inclusion Criteria:\n\n* DSM 5 criteria for schizophrenia or schizoaffective disorder and stable disease\n* Glazer-Morgenstern-Doucette criteria for TD\n* Smoking at least 5 cigarettes on average daily for at least 30 days prior to screening\n* An exhaled carbon monoxide concentration greater than 5 parts per million (ppm) at screening\n* Agree to stop smoking by the target date (four weeks after baseline\n* Concurrence for varenicline treatment from the patient's mental health provider if the patient is under mental health care; OR, if the patient is not under mental health care, the prescribing clinician should consult with a mental health provider to evaluate the patient for appropriateness to receive varenicline\n\nExclusion Criteria:\n\n* Have untreated or unstable acute medical or psychiatric illnesses\n* Have a history of seizures\n* History of somnambulism\n* Have chronic degenerative neurological illnesses (e.g., Parkinson's disease)\n* Have a history of active substance abuse (including marijuana abuse) in the 3 months prior to screening or a positive toxicology screen\n* Are receiving clozapine or cholinesterase inhibitors\n* Had a change in dosing or medication type of antipsychotic or anti-muscarinic for one month prior to enrollment (two months for long-acting antipsychotics)\n* Are unable to remain on a stable dose of antipsychotic or anti-muscarinic during the study period\n* Have acute suicidal ideation, intent or behavior within 12 months or risk based assessed on the C-SSRS or depression\u002Fanxiety score ≥ 8 on the HADS.\n* Female subjects of childbearing age will have a negative pregnancy serum test at screening and are required to use approved methods of birth control\n* Use of an investigational drug within 30 days of screening\n* Use of other smoking cessation aids (bupropion, nicotine replacement products)\n* Use of other tobacco products\n* History of allergic reactions to varenicline\n* Lack capacity to provide informed consent",{"count":164,"type":21},10,[53],"To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.",[56,57,168,27,169],"Tobacco Smoking","Parkinsonism",[56,171,172,173,174,169],"Schizoaffective disorder","Antipsychotics","Tobacco smoking","Tardive dyskinesia","2019-03-20",{"date":177,"type":34},"2019-03-22",{"date":179,"type":34},"2019-01-01",{"date":181,"type":21},"2020-06-30",{"name":183,"class":184},"Corporal Michael J. Crescenz VA Medical Center","FED"]