Improving treatment for acute agitation in psychiatric patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance the pharmacological management of psychiatric patients experiencing acute agitation. It focuses on evaluating the efficacy, tolerability, and safety of two lesser-studied medications compared to the current standard treatment when de-escalation techniques are ineffective. The research will be conducted in inpatient psychiatric settings, where the goal is to minimize suffering and avoid coercive measures. Following the initial phase, the study intends to seek further funding to expand its platform and explore additional treatment options.

Why it matters

Who can join: the full rules

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

Where it's running

• Mental Health Center Copenhagen, Bispebjerg
  Copenhagen N, Denmark Recruiting

Study contacts

• Principal investigator: Lone Baandrup, MD, DMSc — Mental Health Center Copenhagen
• Study coordinator: Lone Baandrup, MD, DMSc
• Email: lone.baandrup@regionh.dk
• Phone: 00 45 91165903

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.