55 completed, 13 unknown, 8 recruiting, 6 terminated. 28 Not applicable, 23 Phase 4, 17 Phase 3, 15 Phase 2, 1 Phase 1.
Follow Agitation: new trials by email Literature Review of Agitation trials Research Report on Agitation
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Virtual Reality to Advance Dementia Care and Quality of Life Supervised Virtual Reality Sessions - Dementia, Agitation | Not applicable | Not yet recruiting | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | 10 | 2026-12-01 | 2026-10-26 |
| 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 Esketamine combined with dexmedetomidine, Dexmedetomidine - Dexmedetomidine, Ketamine | Phase 4 | Not yet recruiting | The First Affiliated Hospital with Nanjing Medical University | 356 | 2026-09-28 | 2026-09-03 |
| Effect of Daily Screen Time on Postoperative Emergence Delirium in Children Aged 2-11 Years Daily Screen Exposure Duration - Agitation, Postoperative Agitation | Recruiting | Kanuni Sultan Suleyman Training and Research Hospital | 288 | 2026-05-01 | 2026-08-05 | |
| PARO-agitation-study PARO - Agitation, POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE | Not applicable | Recruiting | Hannover Medical School | 300 | 2025-12-15 | 2026-05-05 |
| A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) KarXT, KarX-EC - Alzheimer Disease, Agitation | Phase 3 | Recruiting | Bristol-Myers Squibb | 650 | 2025-12-02 | 2026-10-16 |
| Impact of Harp Therapy on Behavioral Disorders in Nursing Home Residents With Neurodegenerative Disease (ARPE) Harp therapy (receptive music therapy) - Neurodegenerative Diseases, Behavioral Symptoms | Completed | LNA SANTE | 25 | 2025-10-01 | 2026-08-07 | |
| Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type 12 cm2 - 2 Active DMTS Patches, 6 cm2 - 1 Active and 1 Placebo DMTS Patches, Placebo - 2 Placebo DMTS Patches - Agitation | Phase 2 | Active not recruiting | Teikoku Pharma USA, Inc. | 150 | 2025-09-16 | 2026-10-27 |
| Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery A novel device developed providing nature-driven responsive imagery that responds to the patient's physiological to distract, engage, and de-escalate behaviours of delirium., Routine post-operative management and standard delirium reduction measures. - Delirium - Postoperative, Agitation | Not applicable | Not yet recruiting | University of British Columbia | 60 | 2025-09-01 | 2025-07-03 |
| Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients. Risk Behavior, Agitation | Recruiting | University Hospital, Clermont-Ferrand | 20 | 2025-07-09 | 2025-07-14 | |
| Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury Haloperidol, Dexmedetomidine - Traumatic Brain Injury, Delirium | Not applicable | Not yet recruiting | Benha University | 40 | 2025-06-15 | 2025-05-28 |
| Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease BMS-986368, Placebo - Agitation, Alzheimer Disease | Phase 2 | Recruiting | Celgene | 120 | 2025-06-09 | 2026-10-06 |
| Acute Agitation in Emergency Psychiatry Sublingual Dexmedetomidine, Buccal midazolam, Oral lorazepam - Agitation | Phase 2 / Phase 3 | Recruiting | Lone Baandrup | 132 | 2024-12-30 | 2025-01-01 |
| Family Videos and Virtual Reality in Intensive Care Patients Family Video.Participants watched a five-minute video prepared by their family members twice daily on the second and third days of intensive care. - Anxiety, Agitation | Not applicable | Completed | Sennur Kula Şahin | 72 | 2024-10-20 | 2026-09-01 |
| Neurosteer Bedside Monitoring System Neurosteer's single-channel EEG monitoring device - Delirium, Sedation | Not applicable | Recruiting | Icahn School of Medicine at Mount Sinai | 100 | 2024-07-08 | 2026-09-28 |
| Life's End Benefits of cannaBidiol and tetrahYdrocannabinol T2:C100, Placebo - Agitation, Dementia | Phase 2 | Completed | University of Southern California | 120 | 2024-01-05 | 2026-09-02 |
| Doll Therapy for Agitated Elderly Dementia People doll therapy - Dementia, Agitation | Not applicable | Completed | Karadeniz Technical University | 60 | 2023-12-01 | 2025-07-10 |
| Acupressure for Agitation, Pain, and Sleep in Mechanically Ventilated ICU Patients Acupressure, Light Touch - Mechanical Ventilation, Critical Illness | Not applicable | Completed | Yang Yun Shiuan | 60 | 2023-10-06 | 2026-06-04 |
| Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department Sublingual film containing dexmedetomidine (BXCL501) - Agitation, Schizophrenia | Phase 4 | Withdrawn | Brigham and Women's Hospital | 2023-09-01 | 2026-01-28 | |
| A Music-Based Mobile App for People Living With Alzheimer's Disease and Related Dementias (ADRD) Feasibility study of music-based mobile app - Dementia, Agitation | Unknown | Autotune Me LLC | 20 | 2023-08-01 | 2023-11-24 | |
| Premature Enhanced Automated Capture of Comfort Knowledge Acute Pain, Pain, Procedural | Unknown | Newcastle University | 100 | 2023-02-01 | 2023-09-14 |
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Psychomotor Agitation (93) · Dementia (18) · Alzheimer Disease (16) · Delirium (15) · Psychotic Disorders (10) · Pain (8) · Aggression (7) · Anxiety Disorders (7) · Schizophrenia (7) · Emergence Delirium (6) · Behavior (3) · Depression (3) · Acute Pain (2) · Agnosia (2) · Behavioral Symptoms (2)
Dyskinesias (93) · Nervous System Diseases (93) · Neurobehavioral Manifestations (93) · Neurologic Manifestations (93) · Pathological Conditions, Signs and Symptoms (93) · Psychomotor Disorders (93) · Signs and Symptoms (93) · Aberrant Motor Behavior in Dementia (92) · Behavioral Symptoms (91) · Behavior (90) · Mental Disorders (60) · Neurocognitive Disorders (49) · Brain Diseases (30) · Central Nervous System Diseases (30) · Confusion (20)
Dexmedetomidine (21) · Haloperidol (9) · Saline Solution (6) · Sodium Chloride (6) · Risperidone (4) · Lorazepam (3) · Midazolam (3) · Standard of Care (3) · Acupuncture Therapy (2) · Fentanyl (2) · Olanzapine (2) · Quetiapine Fumarate (2) · Remifentanil (2) · nabilone (2) · 1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate (1)
BioXcel Therapeutics Inc (6) · Hennepin Healthcare Research Institute (3) · New York State Psychiatric Institute (3) · Ain Shams University (2) · Alexandria University (2) · Brigham and Women's Hospital (2) · China Medical University Hospital (2) · Prince of Songkla University (2) · Seoul National University Hospital (2) · Sunnybrook Health Sciences Centre (2) · University Hospital, Clermont-Ferrand (2) · University of Southern California (2) · Abarbanel Mental Health Center (1) · Ajou University School of Medicine (1) · Assiut University (1)
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BioXcel MM, MD (5) · Jacobo Mintzer, MD (2) · Ahmad Ben Tareef, MD (1) · Alaa Elkateb, MD (1) · Alana Flexman, MD MBA (1) · Anne Lynn, MD (1) · Anton Porsteinsson, MD (1) · Bettina S. Husebo, MD, PhD (1) · Brent P Forester, MD (1) · Brigid Reynolds, NP (1) · Bruce Pollock, MD (1) · Claudia Cooper (1)
PMID 10692189, PMID 19454032, PMID 21765198, PMID 21845596, PMID 22143072, PMID 23075176, PMID 23524149, PMID 23611363, PMID 24549548, PMID 24566243, PMID 24606117, PMID 24806873, PMID 24914549, PMID 25493435, PMID 25791540, PMID 26880794, PMID 27247487, PMID 27524403, PMID 27855483, PMID 28936121, PMID 29136228, PMID 29249041, PMID 29859917, PMID 29866205, PMID 30031556, PMID 30032888, PMID 30282677, PMID 30548977, PMID 30753761, PMID 31003871, PMID 31182351, PMID 31322567, PMID 31547752, PMID 31672419, PMID 32528650, PMID 34059401, PMID 34532852, PMID 35703367, PMID 36002761, PMID 36198061, PMID 36506775, PMID 36733413, PMID 37732619, PMID 40466557, PMID 40562636, PMID 41160116
2008 (1), 2017 (1), 2023 (1), P30AG073105 (1), R01AG021488 (1), R01AG031348 (1), R01AG047146 (1), R01AG068324 (1), R01AG095004 (1), R01MH055735 (1)