Acute Agitation in Emergency Psychiatry

Recruiting now · Phase 2/Phase 3

Conditions studied: Agitation

In brief

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

Key facts

Study ID

NCT06752616

Run by

Lone Baandrup

People needed

132

Starts

2024-12-30

Expected to finish

2027-12-01

Last updated by the study team

2025-01-01

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mental Health Center Copenhagen, Bispebjerg — Copenhagen N, Denmark (enrolling)

Full record on ClinicalTrials.gov

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