Acute Agitation in Emergency Psychiatry

Launched by LONE BAANDRUP · Dec 22, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on finding better ways to treat patients who are experiencing severe agitation in emergency psychiatric settings, like psychiatric emergency rooms. The research team is looking for participants aged 18 to 64 who show signs of agitation and need medication to help calm them down. To qualify, participants must have a specific score indicating their level of agitation and must be able to give informed consent before the emergency occurs.

If you or someone you know is interested in participating, it's important to note that certain conditions may prevent eligibility, such as being involuntarily admitted to a psychiatric facility, being pregnant or breastfeeding, or having certain health issues. Participants will be closely monitored and can expect to receive medications as part of the study to help reduce their agitation. This trial aims to improve treatment options and ultimately enhance care for individuals experiencing acute agitation.

Gender

ALL

Eligibility criteria

• 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