11 completed, 3 recruiting, 2 terminated, 1 active not recruiting. 17 Phase 3, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Completed 11, Recruiting 3, Terminated 2, Active not recruiting 1 |
| Phase 2 | 5 | Completed 4, Recruiting 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 |
|---|---|---|---|---|---|---|
| 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 | 2026-11-12 |
| 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 |
| Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III) BXCL501, Matching Placebo - Agitation, Dementia | Phase 3 | Terminated | BioXcel Therapeutics Inc | 13 | 2022-12-05 | 2026-10-01 |
| Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type Masupirdine 50 mg, Masupirdine 100 mg, Placebo - Agitation, Alzheimer's Type Dementia | Phase 3 | Active not recruiting | Suven Life Sciences Limited | 375 | 2022-11-01 | 2026-09-15 |
| A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation AXS-05, Placebo - Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease | Phase 3 | Completed | Axsome Therapeutics, Inc. | 408 | 2022-09-06 | 2026-08-13 |
| Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) BXCL501, Matching Placebo - Agitation, Dementia | Phase 3 | Completed | BioXcel Therapeutics Inc | 151 | 2022-04-27 | 2026-08-11 |
| Nabilone for Agitation Blinded Intervention Trial Nabilone, Placebo - Alzheimer Disease, Agitation | Phase 3 | Recruiting | Sunnybrook Health Sciences Centre | 112 | 2021-02-01 | 2026-11-06 |
| Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia Sublingual film containing dexmedetomidine (BXCL501), Placebo Film - Agitation, Schizophrenia | Phase 3 | Completed | BioXcel Therapeutics Inc | 380 | 2020-01-24 | 2026-08-11 |
| Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial) Dexmedetomidine, Placebo - Delirium, Agitation | Phase 3 | Completed | University Hospital, Clermont-Ferrand | 168 | 2017-12-21 | 2026-05-13 |
| Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children Dexmedetomidine, saline - Agitation | Phase 2 / Phase 3 | Completed | Assiut University | 90 | 2016-05-01 | 2020-07-14 |
| Safety and Efficacy of Nabilone in Alzheimer's Disease Nabilone, Placebo - Alzheimer Disease, Agitation | Phase 2 / Phase 3 | Completed | Sunnybrook Health Sciences Centre | 38 | 2015-01-01 | 2020-06-25 |
| Pain in Patients With Dementia and Behavioural Disturbances Paracetamol, Morphine, Buprenorphine plaster - Dementia, Pain | Phase 2 / Phase 3 | Completed | University of Bergen | 352 | 2009-11-01 | 2011-08-10 |
| Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children Dexmedetomidine, Saline - Agitation, Anesthesia | Phase 3 | Completed | St. Luke's-Roosevelt Hospital Center | 33 | 2009-08-01 | 2018-11-27 |
| Citalopram for Agitation in Alzheimer's Disease citalopram, placebo - Alzheimer's Disease, Agitation | Phase 3 | Completed | JHSPH Center for Clinical Trials | 186 | 2009-07-01 | 2014-06-27 |
| A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia Intramuscular Haloperidol, Intramuscular Levosulpiride - Agitation | Phase 2 / Phase 3 | Completed | Shanghai Mental Health Center | 240 | 2009-02-01 | 2010-12-03 |
| Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia IM olanzapine, IM haloperidol plus lorazepam - Schizophrenia, Schizoaffective Disorder | Phase 3 | Completed | National Taiwan University Hospital | 67 | 2006-07-01 | 2014-09-15 |
| Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia Depakote ER, Seroquel - Agitation, Dementia | Phase 3 | Terminated | Tuscaloosa Research & Education Advancement Corporation | 20 | 2006-05-01 | 2017-04-27 |
Psychomotor Agitation (17) · Alzheimer Disease (5) · Dementia (4) · Schizophrenia (3) · Pain (2) · Psychotic Disorders (2) · Aggression (1) · Agnosia (1) · Delirium (1) · Emergence Delirium (1) · Marijuana Abuse (1) · Weight Loss (1)
Aberrant Motor Behavior in Dementia (17) · Behavior (17) · Behavioral Symptoms (17) · Dyskinesias (17) · Nervous System Diseases (17) · Neurobehavioral Manifestations (17) · Neurologic Manifestations (17) · Pathological Conditions, Signs and Symptoms (17) · Psychomotor Disorders (17) · Signs and Symptoms (17) · Mental Disorders (14) · Neurocognitive Disorders (11) · Brain Diseases (9) · Central Nervous System Diseases (9) · Dementia (5)
Dexmedetomidine (6) · Lorazepam (2) · Sodium Chloride (2) · nabilone (2) · 1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate (1) · Acetaminophen (1) · Citalopram (1) · Haloperidol (1) · Morphine (1) · Olanzapine (1) · Pregabalin (1) · Quetiapine Fumarate (1) · Saline Solution (1) · Valproic Acid (1) · xanomeline (1)
BioXcel Therapeutics Inc (3) · Sunnybrook Health Sciences Centre (2) · Assiut University (1) · Axsome Therapeutics, Inc. (1) · Bristol-Myers Squibb (1) · JHSPH Center for Clinical Trials (1) · Lone Baandrup (1) · National Taiwan University Hospital (1) · Shanghai Mental Health Center (1) · St. Luke's-Roosevelt Hospital Center (1) · Suven Life Sciences Limited (1) · Tuscaloosa Research & Education Advancement Corporation (1) · University Hospital, Clermont-Ferrand (1) · University of Bergen (1)
United States (9) · Canada (4) · China (2) · Croatia (2) · France (2) · Poland (2) · Taiwan (2) · Argentina (1) · Brazil (1) · Bulgaria (1) · Chile (1) · Czechia (1) · Denmark (1) · Egypt (1) · Germany (1)
BioXcel MM, MD (2) · Anton Porsteinsson, MD (1) · Bettina S. Husebo, MD, PhD (1) · Bruce Pollock, MD (1) · Clive Ballard, MD, PhD (1) · Constantine Lyketsos, MD, MHS (1) · Dag Aarsland, MD, Phd (1) · Daniel Weintraub, MD (1) · Davengere Devanand, MD (1) · David Shade, Esq (1) · Giovanni Marotta, MD (1) · Huafang LI, MD,PhD (1) · Jacobo Mintzer, MD (1)
PMID 21765198, PMID 23611363, PMID 24549548, PMID 24806873, PMID 24914549, PMID 25791540, PMID 27247487, PMID 27524403, PMID 29136228, PMID 29866205, PMID 30753761, PMID 31182351, PMID 31322567, PMID 31547752, PMID 31672419, PMID 34532852, PMID 36002761, PMID 36198061, PMID 41160116
2008 (1), 2017 (1), 2023 (1), R01AG031348 (1)