14 completed, 4 unknown, 4 withdrawn, 1 not yet recruiting. 23 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 23 | Completed 14, Unknown 4, Withdrawn 4, Not yet recruiting 1 |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 |
|---|---|---|---|---|---|---|
| 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 |
| 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in the Emergency Department Sublingual film containing dexmedetomidine (BXCL501) - Agitation, Schizophrenia | Phase 4 | Withdrawn | Brigham and Women's Hospital | 2023-09-01 | 2026-01-28 | |
| 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 |
| 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 |
| 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 |
| 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 |
| Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital Ketamine, Haloperidol - Agitation | Phase 4 | Withdrawn | Hennepin Healthcare Research Institute | 2014-04-01 | 2017-07-24 | |
| Effect of Deksmedetomidine and Remifentanil in Extubation Agitation deksmedetomidine, Remifentanil, Saline - Agitation | Phase 4 | Unknown | Diskapi Yildirim Beyazit Education and Research Hospital | 90 | 2014-04-01 | 2014-04-04 |
| Addition of Magnesium Sulfate to Caudal to Prevent Postoperative Emergence Agitation. Magnesium Sulfate, 0.9%normal saline - Agitation, Pediatric Disorder | Phase 4 | Unknown | Ain Shams University | 70 | 2013-10-01 | 2014-06-17 |
| Dexmedetomidine to Prevent Agitation After Free Flap Surgery Dexmedetomidine, Saline placebo - Agitation, Delirium | Phase 4 | Completed | Peking University | 80 | 2013-06-01 | 2014-11-13 |
| Treating Acutely Agitated Patients With Asenapine Sublingual Tablets Asenapine, Placebo - Agitation | Phase 4 | Completed | Unity Health Toronto | 120 | 2012-04-01 | 2016-05-16 |
| Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery saline, Dexmedetomidine - Agitation | Phase 4 | Completed | Yonsei University | 74 | 2011-10-01 | 2015-02-06 |
| ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children Dexmedetomidine - Agitation | Phase 4 | Unknown | Seoul National University Hospital | 25 | 2011-06-01 | 2011-06-16 |
| Efficacy and Safety of Risperidone and Trazodone Monotherapy and Combination Therapy in Critically Ill Patients With Delirium Risperidone, Trazodone, Placebo - Delirium, Agitation | Phase 4 | Withdrawn | Rochester General Hospital | 2011-03-01 | 2019-09-10 | |
| Ziprasidone vs Standard Therapy for Agitated Patients in the ED ziprasidone, Standard therapy - Psychosis, Agitation | Phase 4 | Withdrawn | George Washington University | 2008-09-01 | 2017-09-25 | |
| Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone Escitalopram, Risperidone - Agitation, Psychosis | Phase 4 | Completed | Abarbanel Mental Health Center | 40 | 2008-04-01 | 2015-06-24 |
| A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room Quetiapine, Haloperidol, Lorazepam - Agitation | Phase 4 | Completed | University of Southern California | 72 | 2006-05-01 | 2019-07-26 |
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Psychomotor Agitation (23) · Psychotic Disorders (6) · Alzheimer Disease (3) · Delirium (3) · Schizophrenia (3) · Aggression (2) · Bipolar Disorder (2) · Agnosia (1) · Dementia (1) · Pain, Postoperative (1) · Respiratory Insufficiency (1) · Sepsis (1)
Aberrant Motor Behavior in Dementia (23) · Behavior (23) · Behavioral Symptoms (23) · Dyskinesias (23) · Nervous System Diseases (23) · Neurobehavioral Manifestations (23) · Neurologic Manifestations (23) · Pathological Conditions, Signs and Symptoms (23) · Psychomotor Disorders (23) · Signs and Symptoms (23) · Mental Disorders (9) · Schizophrenia Spectrum and Other Psychotic Disorders (7) · Neurocognitive Disorders (6) · Brain Diseases (3) · Central Nervous System Diseases (3)
Dexmedetomidine (7) · Haloperidol (4) · Risperidone (4) · Saline Solution (3) · Sodium Chloride (3) · Remifentanil (2) · Benztropine (1) · Chlorpromazine (1) · Dexetimide (1) · Escitalopram (1) · Fentanyl (1) · Fumigant 93 (1) · Ketamine (1) · Lorazepam (1) · Magnesium Sulfate (1)
Ain Shams University (2) · New York State Psychiatric Institute (2) · Abarbanel Mental Health Center (1) · Ajou University School of Medicine (1) · Alexandria University (1) · Brigham and Women's Hospital (1) · Cukurova University (1) · Diskapi Yildirim Beyazit Education and Research Hospital (1) · Ferrer Internacional S.A. (1) · George Washington University (1) · Hennepin Healthcare Research Institute (1) · Joseph Dib (1) · Peking University (1) · Rochester General Hospital (1) · Seoul National University Hospital (1)
United States (8) · Egypt (3) · South Korea (3) · China (2) · Turkey (Türkiye) (2) · Israel (1) · Lebanon (1) · Spain (1)
Alaa Elkateb, MD (1) · Davangere Devanand, M.D. (1) · Davangere P. Devanand, MD (1) · David Frey, MD (1) · Gabrielle A Carlson, MD (1) · George M Simpson, MD (1) · Hee-Soo Kim, M.D, PhD (1) · Jong Yeop Kim, MD (1) · Kenneth Nugent, MD (1) · Laura Leso, MD (1) · Michael J Pratts, MD (1) · Mindee S Hite, Pharm.D. (1) · Reyhan Polat, MD (1) · Thais B Teixeira, PharmD, PhD (1)
PMID 21845596, PMID 23075176, PMID 24606117, PMID 27855483, PMID 29249041, PMID 30282677, PMID 32528650
R01AG021488 (1), R01MH055735 (1)