33 completed, 8 unknown, 5 withdrawn, 1 not yet recruiting. 48 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 48 | Completed 33, Unknown 8, Withdrawn 5, Not yet recruiting 1, Terminated 1 |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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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in the Emergency Department Sublingual film containing dexmedetomidine (BXCL501) - Agitation, Schizophrenia | Phase 4 | Withdrawn | Brigham and Women's Hospital | 2023-09-01 | 2026-01-28 | |
| Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder Dexmedetomidine, Lorazepam 2 MG/ML - Schizophrenia Agitation, Schizo Affective Disorder | Phase 4 | Unknown | Temple University | 32 | 2023-07-01 | 2023-10-23 |
| Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics Nalbuphine, Dexmedetomidine, normal Saline - Agitation | Phase 4 | Unknown | Alexandria University | 126 | 2022-03-01 | 2022-04-08 |
| Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine Mirtazapine, Melatonin, Placebo - Agitation | Phase 4 | Completed | Ain Shams University | 165 | 2021-06-15 | 2022-04-15 |
| Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy Dexmedetomidine 0.5μg／kg, Dexmedetomidine 1μg／kg - Agitated; State, Acute Reaction to Stress | Phase 4 | Completed | Eye & ENT Hospital of Fudan University | 130 | 2019-01-04 | 2021-06-22 |
| TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting Haloperidol + Promethazine + Chlorpromazine, Haloperidol + Promethazine - Psychiatric Emergency, Aggression | Phase 4 | Completed | Joseph Dib | 100 | 2018-08-28 | 2022-06-14 |
| Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation? Analgesics, Antiemetics - Agitated; State, Acute Reaction to Stress | Phase 4 | Completed | Sakarya University | 60 | 2018-06-01 | 2020-03-18 |
| 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 |
| Gabapentin as Preanesthetic Medication to Fast Procedures in Pediatric´s Oncology Placebo Group, GABA 15mg/kg Group, GABA 30mg/kg Group - Pain, Postoperative, Agitation States as Acute Reaction to Exceptional Stress | Phase 4 | Completed | Hospital Infantil Albert Sabin | 135 | 2017-07-01 | 2018-09-27 |
| The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation Magnesium Sulfate, Normal saline - Agitation,Psychomotor | Phase 4 | Completed | Seoul National University Bundang Hospital | 92 | 2017-03-19 | 2023-09-11 |
| The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation Ziprasidone - Schizophrenia | Phase 4 | Unknown | Yang Fude | 1000 | 2016-10-01 | 2016-10-18 |
| Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting Staccato® Delivery System Loxapine (ADASUVE®) - Agitation | Phase 4 | Completed | Ferrer Internacional S.A. | 323 | 2016-09-08 | 2020-11-04 |
| Comparison of Ketamine-propofol Combinations Ketamine-propofol mixture - Agitation, Postoperative Pain | Phase 4 | Completed | Cukurova University | 75 | 2016-07-01 | 2017-04-20 |
| Scalp Nerve Block on Emergence Agitation Ropivacaine, Remifentanil, Sevoflurane - Agitation | Phase 4 | Completed | Ajou University School of Medicine | 44 | 2015-05-01 | 2017-01-25 |
| Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward Ketamine - Psychomotor Agitation, Psychiatric Disorder | Phase 4 | Completed | Universidad Nacional de Rosario | 500 | 2015-01-01 | 2017-07-13 |
| Does Intraoperative Clonidine Reduce Post Operative Agitation in Children? Clonidine, Placebo - Psychomotor Agitation | Phase 4 | Completed | Copenhagen University Hospital, Rigshospitalet | 379 | 2015-01-01 | 2019-02-11 |
| Study of Sedative Medications in Patients With Severe Infection and Respiratory Failure Propofol, Dexmedetomidine, Fentanyl - Sepsis, Respiratory Failure | Phase 4 | Completed | Texas Tech University Health Sciences Center | 36 | 2014-08-01 | 2020-03-02 |
| Small Doses of Dexmedetomidine for Emergence Agitation Sevoflurane, Dexmedetomidine, Placebo(for Dexmedetomidine) - Emergence Agitation | Phase 4 | Unknown | Tang-Du Hospital | 80 | 2014-05-01 | 2014-06-23 |
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Psychotic Disorders (11) · Alzheimer Disease (7) · Dementia (6) · Schizophrenia (6) · Aggression (4) · Bipolar Disorder (4) · Delirium (4) · Mental Disorders (2) · Nausea (2) · Pain (2) · Pain, Postoperative (2) · Stress Disorders, Traumatic, Acute (2) · Acute Disease (1) · Agnosia (1)
Aberrant Motor Behavior in Dementia (48) · Behavioral Symptoms (48) · Dyskinesias (48) · Nervous System Diseases (48) · Neurobehavioral Manifestations (48) · Neurologic Manifestations (48) · Pathological Conditions, Signs and Symptoms (48) · Psychomotor Disorders (48) · Signs and Symptoms (48) · Behavior (47) · Mental Disorders (22) · Neurocognitive Disorders (14) · Schizophrenia Spectrum and Other Psychotic Disorders (13) · Brain Diseases (10) · Central Nervous System Diseases (10)
Dexmedetomidine (13) · Haloperidol (6) · Saline Solution (6) · Risperidone (5) · Quetiapine Fumarate (4) · Lorazepam (3) · Sodium Chloride (3) · Diphenhydramine (2) · Escitalopram (2) · Ketamine (2) · Loxapine (2) · Magnesium Sulfate (2) · Memantine (2) · Metoclopramide (2) · Olanzapine (2)
Ain Shams University (2) · New York State Psychiatric Institute (2) · Seoul National University Hospital (2) · Abarbanel Mental Health Center (1) · Ajou University School of Medicine (1) · Alexandria University (1) · Assistance Publique - Hôpitaux de Paris (1) · BioXcel Therapeutics Inc (1) · Brigham and Women's Hospital (1) · Copenhagen University Hospital, Rigshospitalet (1) · Cukurova University (1) · Diskapi Yildirim Beyazit Education and Research Hospital (1) · East Kent Hospitals University NHS Foundation Trust (1) · Emory University (1) · Eye & ENT Hospital of Fudan University (1)
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Adrian Leibovici MD (1) · AhYoung Oh (1) · Alaa Elkateb, MD (1) · Ali Fuat Erdem, Professor (1) · Andrea Snow, PhD MS BS (1) · Ben Jong,de, MD (1) · Benjamin W Friedman, MD (1) · BioXcel MM, MD (1) · Brian Daley (1) · Brooke Bender, MD (1) · Davangere Devanand, M.D. (1) · Davangere P. Devanand, MD (1) · David Frey, MD (1) · Didier Dreyfuss, MD (1)
PMID 11442853, PMID 16247923, PMID 20418301, PMID 20705788, PMID 21476613, PMID 21845596, PMID 22567095, PMID 23075176, PMID 23422376, PMID 24606117, PMID 25230144, PMID 26332857, PMID 27264945, PMID 27855483, PMID 28877705, PMID 29249041, PMID 29881956, PMID 30169192, PMID 30282677, PMID 32528650, PMID 34627829
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