Acute Agitation in Emergency Psychiatry
NCT06752616 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2025-01-01
Summary
The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.
Conditions
- Agitation
Interventions
- DRUG
-
Sublingual Dexmedetomidine
Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs
- DRUG
-
Buccal midazolam
Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs
- DRUG
-
Oral lorazepam
Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs
Sponsors & Collaborators
-
Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital
collaborator UNKNOWN -
Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark
collaborator UNKNOWN -
Lone Baandrup
lead OTHER
Principal Investigators
-
Lone Baandrup, MD, DMSc · Mental Health Center Copenhagen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-30
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- Denmark
More Related Trials
-
BXCL501 After Stress to Increase Recovery Success
NCT06943404 ·Status: RECRUITING ·Phase: PHASE2
-
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
NCT03639558 ·Status: COMPLETED ·Phase: PHASE4
-
Rapid Benzodiazepine Detoxification Using Flumazenil - 1
NCT00000246 ·Status: COMPLETED ·Phase: PHASE2
-
Clonidine vs. Dexmedetomidine in Agitated Delirium in Intensive Care Patients
NCT04758936 ·Status: UNKNOWN ·Phase: PHASE4
-
Neurobiology and Pharmacokinets of Acute MDMA Administration
NCT01148342 ·Status: COMPLETED ·Phase: PHASE1
-
Haloperidol vs. Valproate in Agitation
NCT01750541 ·Status: COMPLETED ·Phase: PHASE3
-
Amantadine for the Treatment of Traumatic Brain Injury Irritability and Aggression: A Multi-site Study
NCT00779324 ·Status: COMPLETED ·Phase: NA
-
Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
NCT06335407 ·Status: RECRUITING ·Phase: PHASE1
-
Psychopharmacological Treatment of Emotional Distress
NCT06133114 ·Status: RECRUITING ·Phase: PHASE4
-
Identification of Psychoactive Substance Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department
NCT04173546 ·Status: COMPLETED
-
Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
NCT03090620 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users
NCT00902772 ·Status: COMPLETED ·Phase: PHASE1
-
Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder
NCT00353938 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
NCT03095066 ·Status: COMPLETED ·Phase: PHASE2
-
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
NCT03110900 ·Status: TERMINATED ·Phase: PHASE4
-
Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users
NCT03657355 ·Status: COMPLETED ·Phase: PHASE1
-
Pain and Anxiety Management of Traumatic Emergency in a Pre-hospital Setting
NCT01151696 ·Status: COMPLETED ·Phase: PHASE4
-
Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital
NCT02103881 ·Status: WITHDRAWN ·Phase: PHASE4
-
Oxytocin, Trauma Disclosure and Intrusions
NCT03425929 ·Status: COMPLETED ·Phase: PHASE1
-
Identification of Iatrogenic Drug Events Upon Admission to the Adult Emergency Departments
NCT07333131 ·Status: RECRUITING
-
Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation
NCT04792658 ·Status: UNKNOWN
-
Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction
NCT03527316 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Spectroscopic Imaging at 4T: A Drug Challenge Study
NCT01577706 ·Status: TERMINATED ·Phase: NA
-
Characterization of the Prosocial and Prosexual Effects of GHB
NCT02342366 ·Status: COMPLETED ·Phase: NA
-
A Study to Examine the Distribution of PF-06372865 in the Brain of Healthy Volunteers Using Positron Emission Tomography and a Radioactive Tracer Following Oral Administration of One Dose of PF-06372865
NCT02138500 ·Status: COMPLETED ·Phase: PHASE1