Actively Recruiting
Improving Treatment for Acute Agitation in Psychiatric Emergency and Inpatient Care A Study Comparing Sublingual Dexmedetomidine, Buccal Midazolam, and Oral Lorazepam
Led by Lone Baandrup · Updated on 2025-01-01
132
Participants Needed
1
Research Sites
152 weeks
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 investigating better medication options for adults aged 18 to 64 who experience acute agitation in inpatient psychiatric settings, including emergency psychiatric rooms. The study aims to reduce suffering, prevent harm to self or others, and avoid the need for physical or mechanical restraints by comparing two less-studied drugs against the current standard care when de-escalation techniques do not work. This is a Phase 2 and Phase 3 trial focused on improving treatment quality and safety in emergency psychiatry. Participants will receive one of three treatments: sublingual dexmedetomidine (180 mcg with an optional second dose of 90 mcg after 2 hours), buccal midazolam (10 mg with a possible second 10 mg dose after 2 hours), or oral lorazepam (4 mg with a possible second 4 mg dose after 2 hours). These treatments are evaluated for their effectiveness and tolerability in calming acute agitation. The study tests the drugs' effects shortly after administration and may include a second dose depending on response. During the study, participants' agitation levels will be assessed using the Excited Component of the Positive and Negative Syndrome Scale (PEC) 60 minutes after treatment. Researchers will monitor safety, tolerability, and symptom improvement. The trial requires informed consent obtained before the emergency situation, and participants will be carefully observed to evaluate which treatment best controls agitation while minimizing side effects.
CONDITIONS
Official Title
Acute Agitation in Emergency Psychiatry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 64 years
- Agitation requiring tranquilization in inpatient psychiatric settings including emergency rooms
- Total score of at least 14 on the PANSS Excited Component (PEC)
- A score of 4 or higher on at least one of the five PEC items
- Informed consent given before the emergency occurs
You will not qualify if you...
- Involuntary psychiatric admission under the Danish Mental Health Act
- Female patients who are breastfeeding
- Females under 50 years who cannot confirm a negative pregnancy test and safe contraceptive use
- Body weight less than 50 kg
- Extreme obesity with body mass index of 40 kg/m2 or higher
- Situations where antipsychotic drugs are preferred for acute agitation treatment
- Unwillingness or inability to cooperate with study procedures
- Insufficient language skills to read, write, or provide informed consent in Danish or other available languages
- Suspected contraindications for any treatment arms
- Use of benzodiazepines, sedatives, or antipsychotics within 4 hours before study treatment
- Known allergy to any study medications
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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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