Acute Agitation in Emergency Psychiatry (NCT06752616) | Clinical Trial Compass
RecruitingPhase 2/3
Acute Agitation in Emergency Psychiatry
Denmark132 participantsStarted 2024-12-30
Plain-language summary
The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Excited Component of the Positive and Negative Syndrome Scale (PEC)