Improving treatment for acute agitation in psychiatric patients

Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry

This study is testing two new medications to see if they can help calm down psychiatric patients who are very agitated when usual methods don't work.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: University of Copenhagen (other)
• Locations: 1 site (Copenhagen N)
• Trial ID: NCT06752616 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-64 who are experiencing significant agitation and require tranquilization in a psychiatric inpatient setting.

Not a fit: Patients who are involuntarily admitted or have specific medical conditions that necessitate immediate antipsychotic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and humane treatment options for patients with acute agitation.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving treatment for acute agitation, indicating potential for success.

Eligibility criteria

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 this trial is running

Copenhagen N

• 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

Conditions: Agitation, Emergency psychiatry