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Study on Dexmedetomidine, Midazolam, and Lorazepam for Treating Acute Agitation in Emergency Psychiatry Patients

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What is this study about?

This clinical trial is focused on improving the treatment and care for people experiencing acute agitation in emergency psychiatric settings. Acute agitation is a state of extreme restlessness and emotional disturbance that can occur in individuals with psychiatric conditions. The study will compare the effectiveness of three different medications in calming patients: dexmedetomidine (known as Igalmi), lorazepam (known as Lorazepam Orion), and midazolam (known as Midazolam Medical Valley). Dexmedetomidine is administered as a sublingual film, which means it dissolves under the tongue. Lorazepam is taken orally in tablet form, and midazolam is given as an oromucosal solution, which is absorbed through the lining of the mouth.

The purpose of the study is to evaluate how well these medications work in calming patients who are experiencing acute agitation. Participants will receive a single dose of one of the medications, and their level of agitation will be monitored over a period of time. The study aims to determine which medication is most effective in reducing agitation quickly and safely. The trial will also assess how satisfied patients are with the treatment they receive.

Throughout the study, participants will be observed to see how quickly they become calm or fall asleep after taking the medication. The need for additional medication or physical restraint will also be recorded. This research is important for finding the best ways to manage acute agitation in emergency psychiatric care, ensuring that patients receive the most effective and comfortable treatment possible.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age between 18-64 years, presence of agitation requiring tranquillization in psychiatric settings, and a specific score on the PANSS Excited Component (PEC).

Informed consent is obtained before any emergency occurs.

2 initial assessment

An initial assessment is conducted to evaluate the level of agitation using the PANSS Excited Component (PEC) score.

3 medication administration

A single dose of medication is administered. The options include sublingual dexmedetomidine, oral lorazepam, or buccal midazolam.

The form of administration varies: oral for lorazepam, buccal for midazolam, and sublingual for dexmedetomidine.

4 monitoring and evaluation

The primary endpoint is the change in the PEC score at 60 minutes after the dose.

Secondary endpoints include the earliest time a significant difference in agitation is observed, proportion of patients tranquillized or asleep, and the need for physical or mechanical restraint up to 12 hours post-dose.

Patient satisfaction is assessed using a questionnaire.

5 follow-up

Follow-up assessments occur at 30, 60, 90, and 120 minutes post-dose to monitor changes in agitation levels.

Additional follow-up includes monitoring for any need for rescue medication between 4 to 12 hours after the initial dose.

Who Can Join the Study?

  • Age between 18 and 64 years.
  • Experiencing agitation that requires calming down in a psychiatric hospital setting, including emergency rooms.
  • A total score of 14 or higher on the PANSS Excited Component (PEC), which is a scale used to measure levels of excitement or agitation.
  • A score of 4 or higher on at least one of the five items of the PEC scale.
  • Must have given informed consent before the emergency situation occurs. This means the patient agrees to participate in the study after understanding what it involves.

Who Cannot Join the Study?

  • Patients who are younger than 18 years old cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible.
  • Patients with a history of severe allergic reactions to the study medications cannot join. This means if you have had a serious allergic response to the drugs being tested, you cannot participate.
  • Patients with certain medical conditions that might interfere with the study results are excluded. This means if you have a health issue that could affect how the study works, you cannot take part.
  • Patients who are currently participating in another clinical trial are not allowed to join. This means if you are already in a different study, you cannot be in this one.
  • Patients who have used certain medications recently that might affect the study results are excluded. This means if you have taken drugs that could change the study’s outcome, you cannot participate.
  • Patients with a history of substance abuse or addiction are not eligible. This means if you have had problems with drug or alcohol use, you cannot join the study.
  • Patients who are unable to provide informed consent are excluded. This means if you cannot understand and agree to the study’s terms, you cannot participate.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Psykiatrisk Center Kobenhavn Copenhagen Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.11.2024

Trial locations

Investigated drugs:

Dexmedetomidine is being tested in this trial to see how effective it is in calming patients who are experiencing acute agitation. It is given as a single dose under the tongue, which allows it to be absorbed quickly into the bloodstream. This medication is being compared to another treatment to determine its effectiveness in emergency psychiatric situations.

Lorazepam is a medication commonly used to help calm patients who are experiencing severe agitation or anxiety. In this trial, it is given as a single oral dose and serves as a standard treatment to compare the effectiveness of other medications being tested.

Midazolam is being evaluated in this trial for its ability to quickly calm patients with acute agitation. It is administered as a single dose inside the cheek, allowing for rapid absorption. This medication is being compared to lorazepam to assess its effectiveness in emergency psychiatric care.

Investigated diseases:

Acute Agitation – Acute agitation is a state characterized by excessive restlessness, irritability, and heightened emotional tension. It often manifests as an inability to sit still, rapid speech, and a feeling of inner turmoil. This condition can escalate quickly, leading to aggressive behavior or self-harm if not managed. It is commonly associated with psychiatric disorders, substance use, or medical conditions affecting the brain. The progression of acute agitation can vary, with symptoms intensifying over minutes to hours. It requires prompt attention to prevent escalation and ensure the safety of the individual and those around them.

Trial ID:
2023-510201-18-00
Trial Phase:
Therapeutic use (Phase IV)

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