Acute Agitation in Emergency Psychiatry

Phase 2

Recruiting

• Conditions: Agitation
• Interventions: Drug: Sublingual Dexmedetomidine; Drug: Buccal midazolam; Drug: Oral lorazepam

• Registration Number: NCT06752616
• Lead Sponsor: Lone Baandrup

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?

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Study Start: 2024-12-30
• Study First Posted: 2024-12-30
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2025-01-01
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual dexmedetomidine	Sublingual Dexmedetomidine	-
Buccal midazolam	Buccal midazolam	-
Oral lorazepam	Oral lorazepam	-

Primary Outcome Measures

Name	Time	Method
The Excited Component of the Positive and Negative Syndrome Scale (PEC)	60 minutes	The Excited Component of the Positive and Negative Syndrome Scale (PEC) consists of 5 clinician-rated items associated with agitation from the Positive and Negative Syndrome Scale (PANSS). Scores range from 5 to 35. Higher is worse.

Secondary Outcome Measures

Name	Time	Method
PEC score earliest time with difference	30, 60, 90, and 120 minutes	The earliest time where a statistically significant difference in agitation is apparent as measured by change from baseline PEC score (change from pre- to post-dose PEC score at 30, 60, 90, and 120 minutes)
Tranquillized or asleep	30, 60, 90, and 120 minutes post-dose	Proportion tranquillized or asleep (measured as ≤4 on the BARS\*\*) by 30, 60, 90, and 120 minutes post-dose
Physical restraint	12 hours post-dose	Proportion physically restrained from administration to 12 hours post-dose
Mechanical restraint	12 hours post-dose	Proportion mechanically restrained from administration to 12 hours post-dose
Rescue medication	4-12 hours post-dose	Proportion given rescue medication 4-12 hours post-dose
Patient-reported satisfaction	From 2 to 24 hrs post-dose when the participant is able to cooperate	Patient-reported satisfaction measured using 4 items from the Treatment Satisfaction Questionnaire for Medication II. Each item is answered on a 7-point Likert scale from 1 (extremely dissatisfied) to 7 (extremely satisfied). Score range is from 4 to 28. Higher is better.

Trial Locations

Locations (1)

Mental Health Center Copenhagen, Bispebjerg; 🇩🇰 Copenhagen N, Denmark