Acute Agitation in Emergency Psychiatry

Inclusion Criteria:

• 18-64 years

• Agitation with the need for tranquillization in inpatient psychiatric settingsincluding 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 forpregnancy 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 totreat acute agitation (in the opinion of the investigator)

• The patient deemed unwilling or unable to cooperate with study procedures (in theopinion of the investigator)

• Insufficient language skills that interfere with reading, writing, and providingwritten informed consent in Danish or other available languages (in the opinion ofthe investigator)

• Clinical suspicion of contraindications for one of the treatment arms

• Use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usualtreatment (i.e., additional PN sedative prescriptions) in the 4 hours before studytreatment

• Known allergy to any of the study medications