NCT06752616 · Phase 2 · RECRUITING
Acute Agitation in Emergency Psychiatry
This trial compares three sedating medicines (dexmedetomidine under the tongue, midazolam in the cheek, and lorazepam by mouth) for adults aged 18 to 64 in psychiatric emergency settings. It measures how well each calms acute agitation. It's a Phase 2 trial, testing whether the drugs work and are safe for this use, not yet proven or approved for it.
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're excluded 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-01-01