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Advancing the quality of treatment and care for acute agitation in emergency psychiatry
EU CTIS ID: 2023-510201-18-00
What this study is testing
To examine the efficacy of a single dose sublingual dexmedetomidine versus oral lorazepam, and the efficacy of a single dose buccal midazolam versus oral lorazepam for acute tranquillization.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Involuntary psychiatric admission according to the Danish Mental Health Act
- 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
- 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
See the full eligibility 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
- Involuntary psychiatric admission according to the Danish Mental Health Act
- 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
- 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: severe hepatic impairment, hypotension (systolic blood pressure <90 mmHg), bradycardia (heart rate <60 bpm), 2nd or 3rd degree atrioventricular block in patients without pacemaker, severe ventricular dysfunction, known QTc prolongation, respiratory impairment (need for oxygen supplementation to keep SpO2≥92% or SpO2≥88% in patients with COPD), and sleep apnea
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.