๐ฌIn plain words
What the trial is, and whether it could suit you
The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 18-64 years
* Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms
* Total score of โฅ14 on the PANSS Excited Component (PEC)
* A score โฅ4 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 BMIโฅ 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
๐
What it tests
- Sublingual Dexmedetomidine
- Buccal midazolam
- Oral lorazepam
Mental Health Center Copenhagen, Bispebjerg
Copenhagen N, Denmark
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.