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Clinical Trials in Denmark / NCT06752616
Recruiting Phase 2/3

Acute Agitation in Emergency Psychiatry

NCT06752616 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2/3
Started
2024-12-30
Last updated
2025-01-01

Condition(s) studied

Agitation

Investigational drug(s) / intervention(s)

Sublingual Dexmedetomidine →Buccal midazolamOral lorazepam →

Sublingual Dexmedetomidine: Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs

Buccal midazolam: Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs

Oral lorazepam: Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs

Study summary

The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
Inclusion Criteria: * 18-64 years * Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms * Total score of ≥14 on the PANSS Excited Component (PEC) * A score ≥4 on at least 1 of the 5 items of the PEC * Informed consent obtained prior to the occurrence of the emergency Exclusion Criteria: * Involuntary psychiatric admission according to the Danish Mental Health Act * Female patients who are breastfeeding * Female patients aged \<50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives * Body weight \<50 kg * Extreme obesity defined as estimated BMI≥ 40 kg/m2 * Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator) * The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator) * Insufficient language skills that interfere with reading, writing, and providing written informed consent in Danish or other available languages (in the opinion of the investigator) * Clinical suspicion of contraindications for one of the treatment arms * Use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usual treatment (i.e., additional PN sedative prescriptions) in the 4 hours before study treatment * Known allergy to any of the study medications

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Mental Health Center Copenhagen, Bispebjerg Copenhagen N Denmark Recruiting

More Lone Baandrup trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06752616 on ClinicalTrials.gov ↗ ← All trials in Denmark