14 completed, 3 terminated, 2 active not recruiting, 2 unknown. 5 Not applicable, 5 Phase 2, 5 Phase 3, 3 Phase 4, 1 Early Phase 1.
Follow Agitation,Psychomotor: new trials by email Literature Review of Agitation,Psychomotor trials Research Report on Agitation,Psychomotor
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 |
|---|---|---|---|---|---|---|
| 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 |
| Dronabinol for Agitation in Dementia Crossover Trial Dronabinol - Dementia Moderate, Dementia Severe | Phase 2 | Withdrawn | Ralph H. Johnson VA Medical Center | 2023-11-01 | 2024-07-05 | |
| Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder Sublingual film containing Igalmi - Bipolar Disorder, Schizophrenia | Phase 4 | Completed | BioXcel Therapeutics Inc | 29 | 2023-10-02 | 2026-08-11 |
| A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use Multicomponent intervention program - Agitation,Psychomotor | Not applicable | Recruiting | Radboud University Medical Center | 480 | 2023-06-01 | 2026-08-20 |
| 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 |
| A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia. Medical Cannabis, Placebo Oil - Agitation,Psychomotor, Disruptive Behavior | Not applicable | Terminated | M. H MediCane Ltd. | 24 | 2022-10-12 | 2024-06-27 |
| Clinical Trial on Agitation in Alzheimer's Dementia IGC-AD1-Active, IGC-AD1-Placebo - Alzheimer Disease, Agitation,Psychomotor | Phase 2 | Active not recruiting | IGC Pharma, LLC | 164 | 2022-10-11 | 2026-09-30 |
| Physical Restraints in Intensive Care Unit Patients ARBORea decision-making tool - Critically Ill, Intensive Care Unit Delirium | Not applicable | Completed | University Hospital, Clermont-Ferrand | 4000 | 2022-05-18 | 2026-07-10 |
| Safe Brain Initiative, Operationalizing Precision Anaesthesia Patient reported ourcomes - Neurocognitive Disorders, Post Operative Delirium | Unknown | University of Southern Denmark | 15000 | 2021-12-01 | 2024-06-07 | |
| CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial Calming Touch - Dementia, Agitation,Psychomotor | Not applicable | Completed | University College Copenhagen | 20 | 2021-10-04 | 2023-09-07 |
| Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD) Electroconvulsive Therapy (ECT) - Alzheimer Dementia, Agitation,Psychomotor | Not applicable | Completed | Brent Forester | 41 | 2021-01-28 | 2026-07-30 |
| Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia high CBD/low THC sublingual solution - Alzheimer Disease, Anxiety | Early Phase 1 | Active not recruiting | Mclean Hospital | 12 | 2021-01-11 | 2026-03-30 |
| 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 |
| 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 |
| Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia Sublingual film containing Dexmedetomidine, Sublingual Placebo Film - Agitation,Psychomotor, Dementia | Phase 1 / Phase 2 | Completed | BioXcel Therapeutics Inc | 100 | 2019-12-27 | 2026-08-11 |
| Delirium, Agitation/Sedation, Pain and Dyspnea in Respiratory Intensive Care Unit (NIVILIUM) Observation - Respiratory Failure, Delirium | Unknown | University of Modena and Reggio Emilia | 92 | 2019-08-01 | 2023-05-10 | |
| Mindful Melody: Feasibility of Implementing Music Listening on an Inpatient Psychiatric Unit and Its Relation to the Use of As Needed Medications for Acute Agitation Music - Agitated; State, Acute Reaction to Stress, Agitation,Psychomotor | Completed | State University of New York - Upstate Medical University | 172 | 2018-08-16 | 2020-08-17 | |
| Agitation Follow up After Introduction of a New Patient Care Algorithm Implementation of agitation care algorithm - Agitation,Psychomotor | Completed | University Hospital, Grenoble | 138 | 2018-07-19 | 2024-05-28 | |
| Olanzapine Versus Midazolam for Agitation Olanzapine, Midazolam - Agitation,Psychomotor | Terminated | Hennepin Healthcare Research Institute | 206 | 2018-06-18 | 2019-05-13 | |
| Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation Haloperidol + lorazepam, Loxapine - Agitation,Psychomotor, Haloperidol Causing Adverse Effects in Therapeutic Use | Phase 4 | Terminated | University of Arkansas | 2 | 2017-09-30 | 2018-06-11 |
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Psychomotor Agitation (25) · Dementia (7) · Alzheimer Disease (6) · Schizophrenia (4) · Anxiety Disorders (3) · Bipolar Disorder (3) · Delirium (2) · Pain (2) · Psychotic Disorders (2) · Aggression (1) · Behavior (1) · Behavioral Symptoms (1) · Body Temperature Changes (1) · Brain Injuries, Traumatic (1) · Caregiver Burden (1)
Aberrant Motor Behavior in Dementia (25) · Dyskinesias (25) · Nervous System Diseases (25) · Neurobehavioral Manifestations (25) · Neurologic Manifestations (25) · Pathological Conditions, Signs and Symptoms (25) · Psychomotor Disorders (25) · Signs and Symptoms (25) · Behavior (24) · Behavioral Symptoms (24) · Mental Disorders (18) · Neurocognitive Disorders (11) · Brain Diseases (10) · Central Nervous System Diseases (10) · Neurodegenerative Diseases (6)
Dexmedetomidine (4) · Haloperidol (3) · Loxapine (3) · Midazolam (2) · Olanzapine (2) · ziprasidone (2) · Bupropion (1) · Dronabinol (1) · Exercise (1) · Lorazepam (1) · Magnesium Sulfate (1) · Medical Marijuana (1) · Music Therapy (1) · Observation (1) · Saline Solution (1)
BioXcel Therapeutics Inc (4) · Axsome Therapeutics, Inc. (2) · Hennepin Healthcare Research Institute (2) · Alexza Pharmaceuticals, Inc. (1) · Brent Forester (1) · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal (1) · IGC Pharma, LLC (1) · M. H MediCane Ltd. (1) · Mclean Hospital (1) · Radboud University Medical Center (1) · Ralph H. Johnson VA Medical Center (1) · Seoul National University Bundang Hospital (1) · State University of New York - Upstate Medical University (1) · University College Copenhagen (1) · University Hospital, Clermont-Ferrand (1)
United States (15) · Canada (2) · Denmark (2) · France (2) · Australia (1) · Israel (1) · Italy (1) · Netherlands (1) · Puerto Rico (1) · South Korea (1)
BioXcel MM (2) · BioXcel MM, MD (2) · Lauren Klein, MD (2) · Bram Tilburgs, PhD (1) · Brent P Forester, MD, MSc (1) · Claire Chapuis, Dr (1) · Erik Kulstad, MD (1) · Finn M. Radtke, Professor (1) · George Petrides, MD (1) · Ipsit V Vahia, MD (1) · Jacobo E Mintzer, MD (1) · Jessica E Broadway, MD (1) · Jonna Jensen, Ass. Prof. (1) · Mark van den Boogaard, PhD (1) · Michael P Wilson, MD (1)
PMID 20528148, PMID 25210413, PMID 29885904, PMID 33676455, PMID 35191924, PMID 36002761, PMID 36280451, PMID 38082351, PMID 38972091, PMID 40398949