RecruitingPhase 2Phase 3NCT06752616

Acute Agitation in Emergency Psychiatry

Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry

Sponsor

Lone Baandrup

Enrollment

132 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 64 Years

-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

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