Menu
Recruiting NCT06752616

Acute Agitation in Emergency Psychiatry

Phase II / Phase III Interventional Agitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sublingual Dexmedetomidine, Buccal midazolam, Oral lorazepam.
Who it may be relevant to
Registry conditions: Agitation. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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?

Interventions

  • Drug Sublingual Dexmedetomidine
    Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs
  • Drug Buccal midazolam
    Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs
  • Drug Oral lorazepam
    Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs

Primary outcome measures

  • The Excited Component of the Positive and Negative Syndrome Scale (PEC) [Time frame: 60 minutes]
Secondary outcome measures (6)
  • PEC score earliest time with difference [Time frame: 30, 60, 90, and 120 minutes]
  • Tranquillized or asleep [Time frame: 30, 60, 90, and 120 minutes post-dose]
  • Physical restraint [Time frame: 12 hours post-dose]
  • Mechanical restraint [Time frame: 12 hours post-dose]
  • Rescue medication [Time frame: 4-12 hours post-dose]
  • Patient-reported satisfaction [Time frame: From 2 to 24 hrs post-dose when the participant is able to cooperate]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Mental Health Center Copenhagen, Bispebjerg — Copenhagen N

Identifiers

NCT: NCT06752616 · 2023-510201-18-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗