37 completed, 8 terminated, 4 recruiting, 3 active not recruiting. 54 Phase 3, 8 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 54 | Completed 37, Terminated 8, Recruiting 4, Active not recruiting 3, Not yet recruiting 1, Unknown 1 |
| Phase 2 | 8 | Completed 5, Not yet recruiting 1, Recruiting 1, Terminated 1 |
Follow Psychomotor Agitation: new trials by email Literature Review of Psychomotor Agitation trials Research Report on Psychomotor 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 | 2026-10-16 |
| A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Placebo - Alzheimer's Disease | Phase 3 | Recruiting | Bristol-Myers Squibb | 426 | 2025-07-16 | 2026-11-03 |
| 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 |
| An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study AXS-05 (dextromethorphan-bupropion) - Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease | Phase 3 | Terminated | Axsome Therapeutics, Inc. | 139 | 2024-11-21 | 2026-06-25 |
| Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients Dexmedetomidine, Placebo - Traumatic Brain Injury, Agitation,Psychomotor | Phase 2 / Phase 3 | Not yet recruiting | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | 72 | 2024-10-01 | 2024-10-01 |
| 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 |
| Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) BXCL501, Matching Placebo - Agitation,Psychomotor, Bipolar I Disorder | Phase 3 | Completed | BioXcel Therapeutics Inc | 452 | 2022-11-21 | 2026-08-07 |
| 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 |
| A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction Lithium Carbonate, Placebo - Carotid Artery Diseases, Carotid Artery Stenosis | Phase 3 | Terminated | Negovsky Reanimatology Research Institute | 107 | 2021-11-20 | 2025-09-25 |
| A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation AXS-05 (dextromethorphan-bupropion), Placebo - Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease | Phase 3 | Completed | Axsome Therapeutics, Inc. | 456 | 2021-06-17 | 2025-12-08 |
| Goal-Directed Sedation in Mechanically Ventilated Infants and Children Dexmedetomidine, Midazolam - Delirium, Critical Illness | Phase 3 | Active not recruiting | Vanderbilt University Medical Center | 372 | 2021-05-10 | 2026-10-20 |
| 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 |
| Assessing Clinical Outcomes in 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. | 178 | 2020-12-31 | 2023-11-29 |
| Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type AVP-786, Placebo - Agitation in Patients With Dementia of the Alzheimer's Type | Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 241 | 2020-09-11 | 2025-05-30 |
| Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type AVP-786, Placebo - Agitation in Patients With Dementia of the Alzheimer's Type | Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 184 | 2020-07-13 | 2025-05-30 |
| Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder Sublingual film containing Dexmedetomidine (BXCL501), Placebo Film - Agitation Associated With Bipolar Disorder, Agitation,Psychomotor | Phase 3 | Completed | BioXcel Therapeutics Inc | 380 | 2020-02-24 | 2026-08-11 |
| 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 |
| A Study of Staccato Loxapine (ADASUVE®) for Inhalation Inhaled loxapine, Inhaled placebo - Psychomotor Agitation, Schizophrenia | Phase 3 | Unknown | Lee's Pharmaceutical Limited | 150 | 2019-12-01 | 2019-11-05 |
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Alzheimer Disease (26) · Dementia (13) · Schizophrenia (7) · Psychotic Disorders (4) · Bipolar Disorder (3) · Cognitive Dysfunction (3) · Delirium (3) · Dementia, Vascular (2) · Emergence Delirium (2) · Mental Disorders (2) · Nervous System Diseases (2) · Neurocognitive Disorders (2) · Pain (2) · Aggression (1)
Aberrant Motor Behavior in Dementia (54) · Behavior (54) · Dyskinesias (54) · Neurobehavioral Manifestations (54) · Neurologic Manifestations (54) · Pathological Conditions, Signs and Symptoms (54) · Psychomotor Disorders (54) · Signs and Symptoms (54) · Behavioral Symptoms (53) · Nervous System Diseases (52) · Mental Disorders (43) · Neurocognitive Disorders (33) · Brain Diseases (32) · Central Nervous System Diseases (32) · Neurodegenerative Diseases (26)
Dexmedetomidine (10) · Haloperidol (4) · Loxapine (4) · brexpiprazole (4) · Sodium Chloride (3) · Valproic Acid (3) · Citalopram (2) · Clonidine (2) · Lorazepam (2) · Midazolam (2) · nabilone (2) · xanomeline (2) · 1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate (1) · Acetaminophen (1) · Baclofen (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (8) · Axsome Therapeutics, Inc. (5) · BioXcel Therapeutics Inc (5) · Alexza Pharmaceuticals, Inc. (2) · Bristol-Myers Squibb (2) · JHSPH Center for Clinical Trials (2) · Sunnybrook Health Sciences Centre (2) · Alzheimer's Disease Cooperative Study (ADCS) (1) · Assiut University (1) · Bruce Pollock (1) · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal (1) · Forest Laboratories (1) · Griffin Hospital (1) · Johns Hopkins University (1) · Lee's Pharmaceutical Limited (1)
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BioXcel MM (2) · BioXcel MM, MD (2) · Constantine Lyketsos, MD, MHS (2) · Robert S Fishman, MD (2) · Alex SR Souza, PhD (1) · Anton Porsteinsson, MD (1) · Bettina S. Husebo, MD, PhD (1) · Bruce G. Pollock, M.D., Ph.D. (1) · Bruce Pollock, MD (1) · Clive Ballard, MD, PhD (1) · Dag Aarsland, MD, Phd (1) · Daniel Weintraub, MD (1) · Davengere Devanand, MD (1) · David Shade, Esq (1)
PMID 40681915, PMID 41533472, PMID 41961243, PMID 39108660, PMID 41591746, PMID 29163985, PMID 31708380, PMID 36002761, PMID 40847656, PMID 41439450, PMID 41689409, PMID 42052145, PMID 42502037, PMID 11087767, PMID 11133600, PMID 11473855, PMID 16677266, PMID 17416907, PMID 21765198, PMID 21810649, PMID 23422376, PMID 23611363, PMID 24549548, PMID 24806873, PMID 24914549, PMID 25791540, PMID 27247487, PMID 27524403, PMID 27542731, PMID 29136228, PMID 29746373, PMID 29866205, PMID 30753761, PMID 31182351, PMID 31322567, PMID 31547752, PMID 31587995, PMID 31672419, PMID 33620407, PMID 33712253, PMID 33853394, PMID 34344312, PMID 34532852, PMID 34688369, PMID 35191924, PMID 36198061, PMID 37929672, PMID 37930669, PMID 39534972, PMID 39800465
2023 (3), 2017 (2), 1RC2AG036535 (1), 2008 (1), 2025 (1), R01AG031348 (1), R01AG052510 (1), R01MH059666 (1), R01NR015226 (1), R21DA029295 (1), R61HL151951 (1), U01AG010483 (1)