[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"agitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:agitation":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,49,80,104,126,152,174,198,223,251,274,303,330],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100622004","phase-4-safety-and-efficacy-of-esketamine---dexmedetomidine-combination-versus-dexmedetomidine-monotherapy-for-hyperactive-delirium-in-icu-patients-on-non-invasive-respiratory-support-seed-nirs-trial-study-protocol-of-a-randomized-controlled-trial-100622004",false,"NCT07377981","Safety and Efficacy of Esketamine - Dexmedetomidine Combination Versus Dexmedetomidine Monotherapy for Hyperactive Delirium in ICU Patients on Non-Invasive Respiratory Support (SEED-NIRS Trial): Study Protocol of a Randomized Controlled Trial","SEED-NIRS","Inclusion Criteria:\n\n1. Age ≥18 years and ≤80 years at the time of randomization;\n2. Hospitalized in the ICU (with an expected ICU stay \\>24 hours);\n3. Patients with hyperactive delirium: meeting criteria for Confusion Assessment Method for the ICU (CAM-ICU)\\[19\\] positivity (i.e., acute onset or fluctuating course plus inattention, and at least one secondary criterion-disorganized thinking or altered level of consciousness) and having agitation which is diagnosed if the Richmond Agitation-Sedation Scale (RASS) score\\[20\\] is superior or equal to +1. (The RASS and CAM-ICU are used to assess sedation and delirium levels. Hyperactive delirium is defined as CAM-ICU positive with RASS \\> +1);\n4. Receiving non-invasive respiratory support (eg. high-flow nasal cannula, CPAP, or non-invasive ventilation) at least for \\>24 hours.\n\nExclusion Criteria:\n\n1. Known or suspected allergy or Contraindications to any of the study drugs;\n2. Severe arrhythmias (e.g., ventricular fibrillation, second- or third-degree atrioventricular block, sick sinus syndrome, ventricular tachycardia, QTc interval ≥470 ms, severe bradycardia (heart rate \\\u003C40 beats per minute), etc.), or left ventricular ejection fraction (LVEF) \\\u003C30%;\n3. Recent administration of esketamine, dexmedetomidine or haloperidol within previous 72 hours.\n4. Pregnancy or lactation;\n5. Conditions that may affect efficacy assessment or cognitive function testing, such as blindness, deafness, aphasic, or coma patients;\n6. History of epilepsy or seizures;\n7. Patients with an estimated survival period of less than 48 hours as judged by the investigator;\n8. Neuropsychiatric conditions per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) that may introduce bias (e.g., active substance use disorder, psychosis, etc.), including alcoholism, drug abuse, or use of psychotropic medications;\n9. Patients receiving non-invasive respiratory support via a tracheostomy;\n10. Patients with untreated or inadequately treated hyperthyroidism;\n11. Severe hepatic insufficiency (Child-Pugh grade C);\n12. Severe renal dysfunction, defined as: chronic renal insufficiency with a glomerular filtration rate (GFR) ≤ 29 mL\u002Fmin\u002F1.73 m²; or subjects on long-term maintenance hemodialysis or peritoneal dialysis;\n13. A history of sleep disorders requiring medical intervention within the past month;\n14. Patients or their legally authorized representatives (family members) who are unable to cooperate or unwilling to provide written informed consent;\n15. Other conditions deemed unsuitable for inclusion by the investigators.","ALL","18 Years","80 Years",{"count":20,"type":21},388,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This investigator-initiated, randomized, controlled, single-blind, superiority trial aims to assess the efficacy and safety of esketamine combined with dexmedetomidine for the management of agitation or delirium in intensive care unit (ICU) patients receiving non-invasive respiratory support. The primary endpoint is a clinically prioritized hierarchical composite endpoint within 28 days, including intubation or tracheostomy, delirium duration, and agitation duration.",[27,28,29,30,31,32,33],"Dexmedetomidine","Ketamine","Analgesia","Respiratory Therapy","Intensive Care Units (ICUs)","Agitation","Sedation and Analgesia",[35,29,32,27,28,31,30],"Sedation and analgesia","NOT_YET_RECRUITING","2026-06-30",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":21},"2026-08-01",{"date":44,"type":21},"2029-01-01",{"name":46,"class":47},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100588118","phase-3-a-study-to-evaluate-the-long-term-efficacy-and-safety-of-karxt--karx-ec-for-agitation-in-alzheimers-disease-adagio-3-100588118","NCT06937229","A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)","A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)","Inclusion Criteria:\n\n* Participants must have completed study CN012-0023 or CN012-0024 per protocol.\n* Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).\n\nExclusion Criteria:\n\n* Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, 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* Other protocol-defined Inclusion\u002FExclusion criteria apply.","55 Years","90 Years",{"count":59,"type":21},650,[61],"PHASE3","The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate\u002Ftrospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.",[64,32],"Alzheimer Disease",[32,66,67,68],"Alzheimer disease","KarXT","KarX-EC","RECRUITING",{"date":71,"type":40},"2026-07-01",{"date":73,"type":40},"2025-12-02",{"date":75,"type":21},"2029-07-20",{"name":77,"class":78},"Bristol-Myers Squibb","INDUSTRY",256,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100520106","phase-2-dexmedetomidine-transdermal-systems-dmts-treatment-for-agitation-associated-with-dementia-of-the-alzheimers-type-100520106","NCT06052254","Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type","A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Agitation Associated With Dementia of the Alzheimer's Type","Inclusion Criteria:\n\n1. Voluntarily provide written informed consent (subject or legally authorized representative \\[LAR\\]).\n2. Male or female, residing in a care facility.\n3. Has a diagnosis of dementia of probable Alzheimer's Disease (AD) based on National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria (2018). The clinical diagnosis of \"probable Alzheimer's Disease (AD)\" will be based on the 2018 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria, which includes patient biomarker data as part of the research diagnosis (Jack et al., 2018). If patient biomarker data are unavailable, per the 2018 NIA-AA diagnostic criteria, the clinical diagnosis of probable AD will be based on the 2011 NIA-AA criteria (McKhann et al., 2011).\n4. Had two or more episodes (using a 7-day lookback period) of agitation that impairs social activities, requires staff or medical intervention, or impairs ability for functional activities of daily living at Screening.\n5. Had an ABS total score ≥ 22 at least once during Day -4 to Day -1 when assessing eligibility on Day 1 Pre-randomization.\n6. Has gone a minimum of 1 week with no change in medication prior to Screening.\n7. Has a score of ≤ 23 on the Mini-Mental State Examination (MMSE) at Screening.\n8. Female subjects who are:\n\n   1. Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter and\n   2. Surgically sterile; or postmenopausal (ie, amenorrhea for ≥2 years as reported by subject\u002Fcaregiver; postmenopausal status will be confirmed with FSH test); or have a monogamous partner who is surgically sterile; or have a same gender sex partner; or is using double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive for 3 months prior to the study, during the study, and for 1 month following the study.\n9. Male subjects who have female sex partners of childbearing potential must be surgically sterile or commit to use a reliable method of birth control during the study and for 1 month following the study. Reliable contraception is defined as: A tubal ligation, condom with spermicidal gel, an approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings, or hormone releasing or copper intrauterine device (IUD).\n10. Has a body weight \\> 50 kg, and body mass index of 20 to 38 kg\u002Fm2, inclusive.\n11. Subject or LAR able to understand the study procedures, comply with all study procedures, and agree to participate in the study program for its full duration.\n12. Has lived in facility for at least 7 days prior to screening and will remain in facility through the completion of Follow-Up assessments.\n\nExclusion Criteria:\n\n1. Has a known sensitivity to dexmedetomidine or any excipient in the DMTS\u002Fplacebo.\n2. Has a skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS\u002Fmatching placebo application site, according to examination by the investigator at screening.\n3. Has a clinically significant abnormal clinical laboratory test value as determined by the investigator.\n4. Has agitation caused by acute intoxication.\n5. Has significant risk of suicide or homicide per investigator's assessment, or any patient with an answer of \"yes\" to Items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS).\n6. Has a history of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.\n7. Has a clinically significant history or clinically significant manifestation of any of the following, as determined by the investigator: a renal (including an estimated glomerular filtration rate \\[eGFR\\] below the appropriate age- and gender-specific range \\[see Section 8.1.3.2\\]), hepatic (including any evidence of ascites and\u002For a Child-Pugh hepatic impairment score \\> 6 \\[Appendix G\\]), cardiovascular, metabolic, neurologic, or psychiatric condition; congestive heart failure, peptic ulcer, gastrointestinal bleeding, or other condition that may preclude participation in the study.\n8. Has a history of physician-diagnosed migraine, frequent non-vascular headaches (\\> 5 per month), seizures, or are currently taking anticonvulsants.\n9. Has a history of syncope or other syncopal attacks.\n10. Has present and\u002For significant history of postural hypotension (determined through examination by the investigator or designee) or history of severe dizziness or fainting on standing in the opinion of the investigator.\n11. Has evidence of a clinically significant 12-lead ECG abnormality.\n12. Has an average heart rate \\\u003C 60 or \\> 100 bpm, systolic blood pressure (BP) \\\u003C 90 or \\> 140 mmHg, or diastolic BP \\\u003C 60 or \\> 90 mmHg, measured in 3 sequential positions (supine after 5 minutes; sitting after 1 minute; and standing after 2 minutes) and after the sequence has been completed 3 times.\n13. Has a history of alcohol abuse or prescription\u002Fillicit drug abuse within the previous 5 years.\n14. Has positive results on the urine drug screen or alcohol breath test indicative of drugs of abuse or alcohol use at screening.\n15. Is receiving concurrent therapy that can interfere with the evaluation of efficacy or safety, such as any drug that in the investigator's opinion may exert significant synergistic interactions with dexmedetomidine.\n\n    Medications with potential cardiac effects (eg, hypotension, bradycardia) and medications that may cause sedation (such as quetiapine \\[Seroquel®\\]), are permissible if the subject has been on a stable dose for a minimum of 30 days prior to Screening and the investigator deems it appropriate.\n\n    Medications given for the treatment of chronic agitation are permissible if the subject has been on a stable dose for a minimum of 30 days prior to Screening.\n16. Uses any natural health products (including chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian, and excluding vitamins or mineral supplements) within 7 days prior to study drug administration and throughout the study, unless in the opinion of the investigator or designee the product will not interfere with the study procedures or data integrity or compromise the safety of the subject.\n17. Had symptoms of an upper respiratory tract infection within 7 days prior to dosing of the study drug.\n18. Utilized oral or injectable corticosteroids within 7 days prior to dosing of the study drug (intranasal and topical corticosteroid use during this time period is allowed).\n19. Received any investigational product within 30 days prior to dosing of the study drug.\n20. Received DMTS in a previous clinical trial.\n21. Has a Johns Hopkins Fall Risk Assessment Score of \\> 13.\n22. In the opinion of the investigator or designee, is considered unsuitable for study entry and\u002For is unlikely to comply with the study protocol for any reason.",{"count":88,"type":21},150,[90],"PHASE2","The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.",[32],[32,94,95],"Dementia","DMTS",{"date":39,"type":40},{"date":98,"type":40},"2025-09-16",{"date":100,"type":21},"2027-05",{"name":102,"class":78},"Teikoku Pharma USA, Inc.",6,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100578260","phase-2-study-to-evaluate-the-efficacy-safety-and-tolerability-of-bms-986368-for-the-treatment-of-agitation-in-participants-with-alzheimers-disease-100578260","NCT06808984","Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease","A Phase 2, Randomized, Double-blind, Three-Arm, Placebo-controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH\u002FMAGL Inhibitor, for the Treatment of Agitation in Participants With Alzheimer's Disease (BALANCE-AAD-1)","Inclusion Criteria\n\n* Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.\n* The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation.\n* History of agitation with onset at least four weeks prior to Screening.\n* MMSE-1 score ≤24.\n* NPI-NH agitation\u002Faggression sub-score ≥ 4.\n* Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver).\n* Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable.\n\nExclusion Criteria\n\n* Clinically significant delusions\u002Fhallucinations requiring hospitalization.\n* History of bipolar disorder, schizophrenia, or schizoaffective disorder.\n* History of major depressive episode with psychotic features during the 12 months prior to Screening.\n* History of delirium within 30 days of Screening.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":112,"type":21},120,[90],"This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH\u002FMAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.",[32,64],"2026-06-01",{"date":118,"type":40},"2026-06-02",{"date":120,"type":40},"2025-06-09",{"date":122,"type":21},"2028-01-07",{"name":124,"class":78},"Celgene",53,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":150,"locationsCount":48},"100636623","paro-agitation-study-100636623","NCT07568093","PARO-agitation-study","Postoperative Agitation, Anxiety and Pain With the Use of the Robotic Tool PARO - A Prospective Randomised Study","Patient inclusion criteria:\n\n* ≥18 years of age\n* Elective visceral surgery\n* german-speaking\n* Patient is capable of giving informed consent\n\nPatient exclusion criteria:\n\n* Known dementia\n* Known immunodeficiency\n* Anacusia\n* Acute damage to the central nervous system\n* A preoperative systemic infection\n* Pre-existing severe immunosuppression or colonization with multidrug-resistant organisms (methicillin resistant Staphylococcus aureus (MRSA), quadruple multidrug-resistant Gram-negative pathogens (MRGN), Candida auris, vancomycin-resistant enterococci (VRE), and linezolid-resistant enterococci (LRE))\n* Postoperative systemic infection\n* Drug dependence\n* Known chronic pain syndrome",{"count":134,"type":21},300,[136],"NA","Postoperative agitation is a common and serious complication in visceral and transplant surgery, associated with prolonged hospital stays and an increased risk of self-harm. Therefore, it is important to find an approach to improve the management of postoperative agitation and to reduce its duration and severity. The medical device \"PARO\" is a robotic seal that enables patient-robot-interaction. Patients respond to the device through verbal communication and motor responses, as well as facial expressions and gestures. The seal detects human interaction through audiovisual recognition, tactile sensors, and the integration of artificial intelligence. The aim of the study is to observe the use of \"PARO\" in patients undergoing elective visceral surgery and to analyze the occurence of agitation.\n\nA decrease in the incidence of postoperative agitation is to be expected in a cohort of patients undergoing visceral surgery who use PARO compared to a group of patients undergoing visceral surgery who do not use PARO.\n\nTo monitor the occurrence of postoperative agitation, a standardized screening will be conducted twice daily for three days using the Richmond Agitation-Sedation Scale (RASS). To assess postoperative pain, anxiety and delirium, the Numerical Pain Scale (NRS), the State-Trait-Anxiety-Inventory (STAI) and a delirium screening tool (3D-CAM\u002FCAM-ICU) are used by a trained study team. The occurrence of other neuropsychiatric symptoms and postoperative surgical complications will also be assessed.\n\nAdditionally, the interaction between PARO and the patients is analyzed regarding movements, reactions to haptic and auditory stimuli, and the frequency of interaction. Our approach involves quantitatively monitoring these metrics to collect sensor data from the robot and video recordings of the patients to identify facial expression and posture patterns. The use and acceptance of the robot on clinical wards by various professional groups are evaluated. The focus is particularly on nursing staff, who have the most interactions with patients. The project is complemented by a hygiene study examining how successfully the hygiene protocol is integrated into clinical routines and what challenges the use of PARO poses in an intensive care unit. The aim is also to examine the workflow and time-related aspects of its usage. The study will be submitted as a clinical trial of the medical device within its intended use, without any additional invasive or burdensome procedures, in accordance with the provisions of Section 15 of the Medical Practitioners Act (MBO).",[32,139,140,141],"POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE","Anxiety After Surgery","Postoperative Pain",[143],"Agitation, postoperative Delirium, Anxiety","2026-04-28",{"date":146,"type":40},"2026-05-05",{"date":148,"type":40},"2025-12-15",{"date":100,"type":21},{"name":151,"class":47},"Hannover Medical School",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":48},"100571323","neurosteer-bedside-monitoring-system-100571323","NCT06718764","Neurosteer Bedside Monitoring System","Evaluating the Feasibility of Utilizing a Novel Brain Activity Monitor in the Neurosciences Intensive Care Unit","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form from patient and\u002For LAR, including stated willingness to comply with all study procedures and availability for the duration of the study\n* Any assigned sex at birth, including individuals who are transgender or intersex\n* Age 18 years or older\n* Mechanically ventilated patients with an anticipated LOS \\>\u002F=48 hours on any sedative drips including propofol, midazolam, dexmedetomidine, fentanyl, dialudid, ketamine\n\nExclusion Criteria:\n\n* Has known hearing problems and usage of hearing aids\n* Has a rash on forehead\n* History of polysubstance abuse\n* Severe dementia\n* Anticipated Withdrawing Life-Sustaining Therapy (WLST) within the next 24-48 hours",{"count":160,"type":21},100,[136],"The purpose of this study is to evaluate the clinical utility of Neurosteer's brain monitoring platform for monitoring delirium, sedation, and agitation in intubated and sedated ICU patients. The research team will be conducting a single-site study. The research team will enroll 100 patients admitted to the NSICU. 50 of these patients will have Acute Neurological Injuries (ANI) and the other 50 will not have an ANI. All enrolled patients will receive the intervention, the Neurosteer brain monitoring device.\n\nThe study intervention consists of the use of Neurosteer's innovative single-channel EEG monitoring device to determine if there is a good correlation and agreement between their signals\u002Fparameters to RASS, CAM-ICU, and continuous EEG monitoring readings. The Neurosteer device will be attached to their forehead and readings will be collected for the duration of their NSICU stay. The research team will adapt the current physical methods of detecting the depth of anesthesia i.e. through the Richmond Agitation-Sedation Scale (RASS) \\& CAM-ICU, to auditory stimulation, which will be delivered through earphones with no physical contact, with the aim of achieving a high correlation between the methods. RASS and CAM-ICU will be collected hourly as standard of care and Neurosteer auditory stimulation will be done 3-4 times a day to coincide with RASS and 1-2 times a day to coincide with CAM-ICU. The research team will correlate collected hourly RASS and CAM-ICU assessments with Neurosteer derived signals and parameters.",[164,165,32],"Delirium","Sedation",{"date":167,"type":40},"2026-05-04",{"date":169,"type":40},"2024-07-08",{"date":171,"type":21},"2026-07",{"name":173,"class":47},"Icahn School of Medicine at Mount Sinai",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":48},"100635454","effect-of-daily-screen-time-on-postoperative-emergence-delirium-in-children-aged-2-11-years-100635454","NCT07552896","Effect of Daily Screen Time on Postoperative Emergence Delirium in Children Aged 2-11 Years","The Effect of Daily Screen Exposure Duration on Postoperative Emergence Delirium in Children Undergoing Elective Lower Abdominal Surgery: A Prospective Observational Study","Inclusion Criteria:\n\n* Children aged 2 to 11 years\n* Scheduled for elective lower abdominal surgery\n* Planned procedures include inguinal hernia repair, orchiopexy for undescended testis, or circumcision\n* American Society of Anesthesiologists (ASA) physical status I-II\n* Parent or legal guardian able to provide written informed consent\n* Parent or legal guardian able to complete the study questionnaire\n\nExclusion Criteria:\n\n* Planned or administered premedication before surgery\n* Emergency surgery\n* Reoperation\n* Developmental delay, neurodevelopmental disorder, or known psychiatric disease\n* Visual or hearing impairment that may interfere with behavioral assessment\n* Current use of sedative, antipsychotic, or antiepileptic medication\n* Anticipated postoperative intensive care unit requirement\n* Incomplete or unreliable parent-reported questionnaire data","2 Years","11 Years",{"count":184,"type":21},288,"OBSERVATIONAL","This prospective observational study aims to evaluate the association between daily screen exposure duration and postoperative emergence delirium in children aged 2 to 11 years undergoing elective lower abdominal surgery. Daily screen time will be assessed using a parent-reported questionnaire administered preoperatively. Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale at 5, 10, 15, and 30 minutes after surgery.\n\nThe primary outcome is the association between daily screen time and PAED score within the first 30 minutes postoperatively. Secondary outcomes include the associations between PAED score and age at first screen exposure, type of viewed content, parental screen use, passive screen exposure, and the presence of a screen in the child's bedroom. The study is designed to improve understanding of whether screen-related environmental factors are associated with postoperative behavioral recovery in pediatric surgical patients.",[32,188],"Postoperative Agitation","2026-04-20",{"date":191,"type":40},"2026-04-27",{"date":193,"type":21},"2026-05-01",{"date":195,"type":21},"2027-05-02",{"name":197,"class":47},"Kanuni Sultan Suleyman Training and Research Hospital",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":103},"100402115","phase-3-nabilone-for-agitation-blinded-intervention-trial-100402115","NCT04516057","Nabilone for Agitation Blinded Intervention Trial","NAB-IT","Inclusion Criteria:\n\n1. Males or females ≥55 years of age; females must be post-menopausal\n2. Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria for Major Neurocognitive Disorder due to AD. Patients with Major Neurocognitive Disorder due to multiple etiologies (AD and vascular) will be included\n3. sMMSE ≤24\n4. Presence of clinically significant agitation based on the IPA definition\n5. If treated with cognitive-enhancing medications (cholinesterase inhibitors and\u002For memantine), dosage must be stable for at least 3 months prior to study randomization\n6. Availability of a primary caregiver to accompany the participant to study visits and to participate in the study. The primary caregiver must be sufficiently proficient in English to complete the required study assessments, as per investigator judgement.\n\nExclusion Criteria:\n\n1. Change in psychotropic medications less than 1 week prior to study randomization (e.g., concomitant antidepressants)\n2. Contraindications to cannabinoids, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions\n3. Current uncontrolled cardiovascular disease (e.g. uncontrolled hypertension, ischemic heart disease, arrhythmia and severe heart failure), as per investigator assessment\n4. Current significant liver disease, as per investigator assessment\n5. Presence or history of other psychiatric disorders or neurological conditions (e.g. psychotic disorders, schizophrenia, stroke, epilepsy)\n6. Participants currently meeting DSM 5 criteria for Major Depressive Episode (MDE)\n7. Previous or current abuse of\u002Fdependence on marijuana\n8. Clinically significant delusions and\u002For hallucinations (NPI-NH delusion\u002Fhallucinations subscore ≥4)\n9. Reported recreational use of marijuana or other cannabis products within 3 months prior to study randomization",{"count":206,"type":21},112,[61],"This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms. Agitation is associated with faster progression to institutionalization, increased caregiver burden, poorer quality of life, and increased risk of death. In addition, current pharmacological options show only modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more effective treatments for agitation in AD is a clinical and research priority.\n\nNabilone is a synthetic cannabinoid that is Health Canada-approved to treat chemotherapy-induced nausea and vomiting.\n\nThe PI's research group completed a 6-week double-blind placebo-controlled randomized cross-over pilot trial in 38 patients with moderate-to-severe AD, providing the first preliminary evidence regarding the safety and efficacy of nabilone in this population. They found that nabilone significantly improved agitation, overall neuropsychiatric symptoms, and caregiver distress. That study was limited by its sample size and questions remain regarding the efficacy of nabilone for nutrition and pain and predictors of response. However, the promising preliminary findings encourage a pivotal, practice-changing phase III trial to inform clinical practice.\n\nParticipants in this study will be randomized to receive either nabilone or a placebo for 8 weeks. In addition to looking at the effectiveness of nabilone in treating agitation, the researchers will also look at whether it is beneficial for other relevant outcomes for patients with AD including overall neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, and pain. Participants will also be followed for 8 weeks following completion of the study treatment.",[64,32],[211,212,213],"Cannabis","Cannabinoid","THC","2026-01-27",{"date":216,"type":40},"2026-01-28",{"date":218,"type":40},"2021-02-01",{"date":220,"type":21},"2027-04",{"name":222,"class":47},"Sunnybrook Health Sciences Centre",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":230,"maxAge":57,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100469809","phase-3-masupirdine-for-the-treatment-of-agitation-in-dementia-of-the-alzheimers-type-100469809","NCT05397639","Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type","A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type","Inclusion Criteria:\n\n* Has a diagnosis of dementia of the Alzheimer's type according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.\n* Has confirmed agitation using the IPA Consensus Provisional Definition of Agitation in Cognitive Disorders.\n* Has a score between 8 and 24 (both inclusive) on Mini-Mental State Examination (MMSE).\n\nExclusion Criteria:\n\n* Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, parkinson's disease, lewy body disease, frontotemporal dementia)\n* Has symptoms of agitation that are not secondary to Alzheimer's disease (eg, pain, other psychiatric disorder, or delirium due to a metabolic disorder, systemic infection, or substance-induced).\n* Participant (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator's judgement.","50 Years",{"count":232,"type":21},375,[61],"This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.",[32,236],"Alzheimer's Type Dementia",[238,239,240,32],"Masupirdine","SUVN-502","Phase 3","2026-01-08",{"date":243,"type":40},"2026-01-12",{"date":245,"type":40},"2022-11-01",{"date":247,"type":21},"2026-12",{"name":249,"class":78},"Suven Life Sciences Limited",44,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":48},"100479412","detection-of-risk-behaviors-pilot-observational-study-with-bedridden-and-agitated-patients-100479412","NCT05522647","Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.","DECORIPAA","Inclusion Criteria:\n\n* Hospitalized in the Neurosurgery Department of the Clermont-Ferrand University Hospital\n* Suffering from neurological and\u002For cognitive disorders leading to agitation and\u002For confusion\n* Affiliation to a social security system\n* Hospitalization in the department for at least 9 days\n* Acceptance by the patient and\u002For trusted person capable of giving informed consent to participate in the research\n\nExclusion Criteria:\n\n* Acute or transient agitation phase of somatic origin (bladder globe, pain, ionic disorder...)\n* Patient under guardianship, curatorship or safeguard of justice\n* Pregnant and breastfeeding women\n* Refusal to participate",{"count":259,"type":21},20,"There is a risk of falls and injuries in bedridden hospitalized patients, increased in agitated or confused patients. In neurosurgery departments, brain damaged patients can present a loss of consciousness of risky behaviors and be in a state of agitation which frequently leads to their endangerment. The repercussions of this endangerment are multiple. For the patients, there may be a feeling of insecurity, with physical or chemical restraint solutions which deprive them of their freedom without a total guarantee of safety. For the caregivers, there is an emotional distress in front of this endangerment, and a professional guilt. Finally, there are economic repercussions due to the costs of complementary examinations and the lengthening of hospitalization.\n\nThe objective of the present study is to determine the nature and frequency of occurrence of risk behaviours, through the observation of bedridden and agitated hospitalized patients. These risk behaviours are defined as potentially dangerous and are warning signs for the caregiver. A better understanding of these behaviours could help to better anticipate falls and injuries and to implement preventive measures more quickly.",[262,32,263,264],"Risk Behavior","Hospitalization","Bedridden Patients","2025-07-10",{"date":267,"type":40},"2025-07-14",{"date":269,"type":40},"2025-07-09",{"date":271,"type":21},"2026-07-31",{"name":273,"class":47},"University Hospital, Clermont-Ferrand",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":290,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":48},"100596870","responsive-nature-driven-imagery-to-reduce-delirium-after-cardiac-surgery-100596870","NCT07051096","Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery","Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery: A Pilot Randomized Controlled Trial","RESPITE","Inclusion Criteria:\n\n* Planned open-heart cardiac surgery (e.g. coronary artery bypass grafting, valve replacement surgery);\n* Able to understand study procedures and provide informed consent in English;\n* At least one delirium risk factor: 1) Age less than 65yrs; 2) History of delirium; 3) History of stroke\u002FTIA; 4) Known cognitive impairment; 5) Depression requiring medication.\n\nExclusion Criteria:\n\n* Severe pre-existing cognitive impairment (Montreal Cognitive Assessment \\[MOCA6\\]\\\u003C10)\n* Uncorrected visual impairment;\n* Significant impairment from psychiatric disease;\n* Enrolment in another clinical trial which may interfere with the study outcome measures.",{"count":283,"type":21},60,[136],"The goal of this clinical trial is to learn if a novel device (MindfulGarden) is beneficial in a population of patients undergoing cardiac surgery. The main questions it aims to answer are:\n\nIs a novel device (MindfulGarden) that uses responsive nature-driven imagery feasible in patients undergoing cardiac surgery? Will use of this device reduce the use of psychotropic medications, improve recovery experience, and improve delirium?\n\nParticipants will receive routine post-operative management and standard delirium reduction measures. They will be randomized into two groups where one receives the novel device (MindfulGarden) and the other does not.",[287,32,288,289],"Delirium - Postoperative","Anxiety","Cardiac Surgery Recovery",[291,164,292,293],"Randomized trial","Cardiac surgery","MindfulGarden","2025-06-26",{"date":296,"type":40},"2025-07-03",{"date":298,"type":21},"2025-09",{"date":300,"type":21},"2027-01",{"name":302,"class":47},"University of British Columbia",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":4},"100592420","comparison-of-haloperidol-and-dexmedetomidine-for-delirium-and-agitation-in-icu-patients-with-traumatic-brain-injury-100592420","NCT06993194","Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury","Comparison Between the Effects of Haloperidol and Dexmedetomidine on Delirium and Agitation in Patients With a Traumatic Brain Injury Admitted to the Intensive Care Unit","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Confirmed diagnosis of traumatic brain injury\n* Admission to the intensive care unit\n* Currently receiving mechanical ventilation\n* Richmond Agitation-Sedation Scale score between -5 and +4\n* At least 48 hours have passed since ICU admission\n\nExclusion Criteria:\n\n* Pre-existing neurological or psychiatric disorders (e.g., schizophrenia, bipolar disorder)\n* Known allergy or contraindication to haloperidol or dexmedetomidine\n* Significant hepatic or renal dysfunction\n* Pregnant or breastfeeding women\n* History of prolonged QT interval or other cardiac arrhythmias\n* Use of long-term antipsychotic or sedative medications before ICU admission",{"count":311,"type":21},40,[136],"Traumatic brain injury is a serious and common medical condition that often requires admission to the intensive care unit and the use of mechanical ventilation. One of the most frequent and challenging complications in these patients is the development of delirium and agitation. These symptoms can prolong hospitalization, increase the risk of further brain injury, and complicate the medical and nursing care of the patient.\n\nThis interventional clinical trial is designed to compare the effects of two medications-haloperidol and dexmedetomidine-on the management of delirium and agitation in patients with traumatic brain injury admitted to the intensive care unit. Haloperidol is a traditional antipsychotic medication that is commonly used to manage agitation, but it may cause undesirable side effects such as movement disorders and disturbances in heart rhythm. Dexmedetomidine is a medication that acts on specific receptors in the nervous system to produce sedation and reduce agitation, and it is believed to cause fewer side effects related to breathing and movement.\n\nThe study will include forty adult patients with confirmed traumatic brain injury. These patients will be randomly assigned to receive either haloperidol or dexmedetomidine according to standard dosing guidelines. The study will evaluate and compare the following outcomes in both treatment groups: the presence and severity of delirium, the level of agitation, the total number of days the patient requires mechanical ventilation, the length of stay in the intensive care unit, the need for additional sedative medications, and the occurrence of any harmful effects from the study drugs.\n\nTo measure these outcomes, patients will be monitored using standardized tools that assess consciousness, agitation levels, and the presence of confusion. Additional medical examinations and laboratory tests will be conducted to ensure patient safety and collect relevant clinical data.\n\nThis study will be carried out in accordance with the ethical guidelines outlined in the Declaration of Helsinki and will follow internationally accepted standards for research involving human participants. Approval has been granted by the appropriate medical ethics committee at the Faculty of Medicine, Benha University. Informed consent will be obtained from all patients or their legal representatives before participation. The purpose of this research is to provide scientific evidence that can help doctors choose the most appropriate and safe medication for managing delirium and agitation in patients with traumatic brain injury who are being treated in the intensive care unit.",[315,164,32],"Traumatic Brain Injury",[315,317,318,319,27,320],"Delirium Management","Agitation in Intensive Care","Haloperidol","Sedation in Brain Injury","2025-05-19",{"date":323,"type":40},"2025-05-28",{"date":325,"type":21},"2025-06-15",{"date":327,"type":21},"2026-06-15",{"name":329,"class":47},"Benha University",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":349,"leadSponsor":351,"locationsCount":48},"100573925","phase-2-acute-agitation-in-emergency-psychiatry-100573925","NCT06752616","Acute Agitation in Emergency Psychiatry","Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry","Inclusion Criteria:\n\n* 18-64 years\n* Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms\n* Total score of ≥14 on the PANSS Excited Component (PEC)\n* A score ≥4 on at least 1 of the 5 items of the PEC\n* Informed consent obtained prior to the occurrence of the emergency\n\nExclusion Criteria:\n\n* Involuntary psychiatric admission according to the Danish Mental Health Act\n* Female patients who are breastfeeding\n* Female patients aged \\\u003C50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives\n* Body weight \\\u003C50 kg\n* Extreme obesity defined as estimated BMI≥ 40 kg\u002Fm2\n* Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator)\n* The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator)\n* Insufficient language skills that interfere with reading, writing, and providing written informed consent in Danish or other available languages (in the opinion of the investigator)\n* Clinical suspicion of contraindications for one of the treatment arms\n* Use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usual treatment (i.e., additional PN sedative prescriptions) in the 4 hours before study treatment\n* Known allergy to any of the study medications","64 Years",{"count":339,"type":21},132,[90,61],"The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.",[32],[344],"Emergency psychiatry","2024-12-30",{"date":347,"type":40},"2025-01-01",{"date":345,"type":40},{"date":350,"type":21},"2027-12",{"name":352,"class":47},"Lone Baandrup"]