BridgeMD
New treatment option for Agitation
Official title Acute Agitation in Emergency Psychiatry
ClinicalTrials.gov ID: NCT06752616
What this study is testing
What is Sublingual Dexmedetomidine?
Sublingual Dexmedetomidine is an investigational medicine, being studied as a potential treatment for agitation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
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
- 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)
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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen N, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen N, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.