Acute Agitation in Emergency Psychiatry

Lone Baandrup

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Agitation

Treatments: Drug: Sublingual Dexmedetomidine; Drug: Buccal midazolam; Drug: Oral lorazepam

Study type: Interventional

Funder types: Other

Identifiers

NCT06752616

2023-510201-18-00

Details and patient eligibility

About

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

Full 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?

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

132 participants in 3 patient groups

Sublingual dexmedetomidine

Experimental group

Treatment:

Drug: Sublingual Dexmedetomidine

Buccal midazolam

Experimental group

Treatment:

Drug: Buccal midazolam

Oral lorazepam

Active Comparator group

Treatment:

Drug: Oral lorazepam