9 completed, 2 recruiting, 2 terminated, 1 active not recruiting. 15 Phase 2, 5 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 15 | Completed 9, Recruiting 2, Terminated 2, Active not recruiting 1, Withdrawn 1 |
| Phase 3 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia BXCL501, Placebo film - Agitation, Dementia | Phase 2 | Terminated | BioXcel Therapeutics Inc | 5 | 2022-02-08 | 2026-08-11 |
| Study of BXCL501 In Agitation Associated With Delirium in ICU Patients BXCL501, Placebo film - Agitation, Delirium | Phase 2 | Withdrawn | BioXcel Therapeutics Inc | 2021-02-23 | 2026-08-11 | |
| A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression MP-101, Placebo - Psychosis, Dementia | Phase 2 | Terminated | Mediti Pharma Inc. | 81 | 2017-05-04 | 2021-04-01 |
| 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 |
| Treatment of Psychosis and Agitation in Alzheimer's Disease Lithium, Placebo - Alzheimer's Disease, Psychosis | Phase 2 | Completed | New York State Psychiatric Institute | 77 | 2014-06-01 | 2024-05-02 |
| Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease AVP-923-20, Placebo, AVP-923-30 - Agitation, Alzheimer's Disease | Phase 2 | Completed | Avanir Pharmaceuticals | 220 | 2012-08-13 | 2021-11-26 |
| 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 |
| 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 |
| Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium Dexmedetomidine, Standard of Care - Delirium, Agitation | Phase 2 | Completed | Brigham and Women's Hospital | 53 | 2006-01-01 | 2017-06-09 |
| A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium dexmedetomidine, haloperidol - Delirium, Agitation | Phase 2 | Completed | Austin Health | 20 | 2005-01-01 | 2013-01-24 |
Psychomotor Agitation (15) · Alzheimer Disease (6) · Dementia (5) · Aggression (3) · Delirium (3) · Pain (2) · Psychotic Disorders (2) · Agnosia (1) · Delusions (1) · Hallucinations (1) · Respiratory Aspiration (1) · Schizophrenia (1) · Weight Loss (1)
Aberrant Motor Behavior in Dementia (15) · Behavior (15) · Behavioral Symptoms (15) · Dyskinesias (15) · Nervous System Diseases (15) · Neurobehavioral Manifestations (15) · Neurologic Manifestations (15) · Pathological Conditions, Signs and Symptoms (15) · Psychomotor Disorders (15) · Signs and Symptoms (15) · Mental Disorders (13) · Neurocognitive Disorders (12) · Brain Diseases (9) · Central Nervous System Diseases (9) · Neurodegenerative Diseases (6)
Dexmedetomidine (5) · Acetaminophen (1) · Haloperidol (1) · LY2812223 (1) · Lithium (1) · Lithium Carbonate (1) · Lorazepam (1) · Morphine (1) · Pregabalin (1) · Saline Solution (1) · Sodium Chloride (1) · Standard of Care (1) · dextromethorphan - quinidine combination (1) · nabilone (1)
BioXcel Therapeutics Inc (2) · Assiut University (1) · Austin Health (1) · Avanir Pharmaceuticals (1) · Brigham and Women's Hospital (1) · Celgene (1) · Lone Baandrup (1) · Mediti Pharma Inc. (1) · New York State Psychiatric Institute (1) · Shanghai Mental Health Center (1) · Sunnybrook Health Sciences Centre (1) · Teikoku Pharma USA, Inc. (1) · University of Bergen (1) · University of Southern California (1)
United States (9) · Canada (2) · China (2) · Argentina (1) · Australia (1) · Denmark (1) · Egypt (1) · Norway (1)
BioXcel MM, MD (2) · Bettina S. Husebo, MD, PhD (1) · Brigid Reynolds, NP (1) · Clive Ballard, MD, PhD (1) · DP Devanand, MD (1) · Dag Aarsland, MD, Phd (1) · Gerald L Weinhouse, MD (1) · Huafang LI, MD,PhD (1) · Jacobo Mintzer, MD (1) · Lone Baandrup, MD, DMSc (1) · Michael C Reade, MBBS FJFICM (1)
PMID 19454032, PMID 21765198, PMID 23611363, PMID 24806873, PMID 27247487, PMID 27524403, PMID 29136228, PMID 29859917, PMID 30753761, PMID 31182351, PMID 31322567, PMID 31547752, PMID 31672419, PMID 34059401, PMID 34532852, PMID 37732619, PMID 40562636
2008 (1), 2023 (1), R01AG047146 (1), R01AG068324 (1), R01AG095004 (1)