Actively Recruiting
Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry
Led by Lone Baandrup · Updated on 2025-01-01
132
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Lone Baandrup
Lead Sponsor
U
University Hospital Bispebjerg and Frederiksberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for acute agitation in psychiatric patients when de-escalation methods do not work. The study aims to find the best medication to reduce suffering and prevent harm or the use of restraints in emergency psychiatric settings. This research focuses on two less-studied drugs compared to the current standard care. The plan includes building a platform to test new treatments and improve care quality for agitated patients. The study tests three medication options: sublingual dexmedetomidine, buccal midazolam, and oral lorazepam. Each drug may be given with a possible second dose two hours later. Participants are randomly assigned to one of these treatments without masking. The goal is to compare how well these drugs control agitation in hospital psychiatric settings. Participants will be monitored for agitation levels using the Excited Component of the Positive and Negative Syndrome Scale (PEC) at multiple times after dosing. Researchers will also track whether patients become calm or asleep, the use of physical or mechanical restraints, rescue medications, and patient satisfaction within 24 hours after treatment. The study runs until December 2027 and involves regular assessments during the inpatient stay to evaluate safety and treatment effects.
CONDITIONS
Brief Title
Acute Agitation in Emergency Psychiatry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 64 years
- Experiencing agitation needing tranquillization in inpatient psychiatric settings or psychiatric emergency rooms
- Total score of 14 or higher on the PANSS Excited Component (PEC)
- Score of 4 or higher on at least one of the five PEC items
- Informed consent given before the emergency situation occurs
You will not qualify if you...
- Involuntary psychiatric admission under the Danish Mental Health Act
- Female patients who are breastfeeding
- Female patients under 50 years old who cannot confirm negative pregnancy or are not using safe contraception
- Body weight less than 50 kg
- Severe obesity with BMI of 40 kg/m2 or higher
- Situations where an antipsychotic is preferred for acute agitation
- Patient unwilling or unable to cooperate with study procedures
- Insufficient language skills to provide written informed consent
- Suspected contraindications for any study treatment
- Use of benzodiazepines, sedatives, or antipsychotics beyond usual treatment within 4 hours before study drug
- Known allergy to any study medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 hours or until sedation is achieved
Participants receive one of three study drugs to manage acute agitation in inpatient psychiatric settings or emergency rooms. The treatment includes a possible second dose 2 hours after the initial dose.
1 baseline visit and multiple assessments up to 2 hours post-dose
Duration - Up to 24 hours post-dose
Participants are monitored for safety and treatment effects including use of restraint, rescue medication, and patient satisfaction after dosing.
Assessments at 4 to 24 hours post-dose
Trial Site Locations
Total: 1 location
1
Mental Health Center Copenhagen, Bispebjerg
Copenhagen N, Denmark, 2400
Actively Recruiting
Research Team
L
Lone Baandrup, MD, DMSc
M
Marie Vang Jensen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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