Clinical trial NCT06752616: Acute Agitation in Emergency Psychiatry
Official title: Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Agitation
Keywords: Emergency psychiatry
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital
name: Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark
First posted: 2024-12-30
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.

Detailed description: The initial treatment of acute agitation aims to reduce suffering, abort the immediate risk of harm to self or others, and prevent the use of coercive measures such a physical and mechanical restraint. With this research project, we aim to build the initial structure of a visionary platform design and to examine the efficacy, tolerability, and safety of two hitherto under-investigated compounds versus the current standard of care for acutely agitated patients when de-escalation techniques have failed. After obtaining the results of the initial phase, we plan to apply for future funding to maintain and expand the platform design with the addition of relevant experimental arms. The proposed platform design aims to anwer the question What is the best treatment for acutely agitated patients in inpatient psychiatric settings?

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

Primary outcomes:
measure: The Excited Component of the Positive and Negative Syndrome Scale (PEC)
timeFrame: 60 minutes
Secondary outcomes:
measure: PEC score earliest time with difference
timeFrame: 30, 60, 90, and 120 minutes
measure: Tranquillized or asleep
timeFrame: 30, 60, 90, and 120 minutes post-dose
measure: Physical restraint
timeFrame: 12 hours post-dose
measure: Mechanical restraint
timeFrame: 12 hours post-dose
measure: Rescue medication
timeFrame: 4-12 hours post-dose
measure: Patient-reported satisfaction
timeFrame: From 2 to 24 hrs post-dose when the participant is able to cooperate
Other outcomes:
Locations:
city: Copenhagen N
country: Denmark
facility: Mental Health Center Copenhagen, Bispebjerg
Study officials:
affiliation: Mental Health Center Copenhagen
name: Lone Baandrup, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: