Ongoing Clinical Trials for Agitation
This article provides information about 2 ongoing clinical trials investigating treatments for agitation. These studies are testing different medications to manage acute agitation in emergency psychiatric settings and agitated behavior in people with dementia. The trials are currently being conducted in Denmark and the Netherlands.
Clinical trial locations
- Denmark
- Netherlands
Study on Dexmedetomidine, Midazolam, and Lorazepam for Treating Acute Agitation in Emergency Psychiatry Patients
This trial is comparing three different medications for treating acute agitation in emergency psychiatric settings. The study aims to find out which medication works best to calm patients quickly and safely.
Who can participate:
- Adults between 18 and 64 years old
- People experiencing agitation that requires calming treatment in a psychiatric hospital or emergency room
- Those with a score of 14 or higher on the PANSS Excited Component scale, which measures agitation levels
- Participants must have a score of 4 or higher on at least one item of the five-item scale
- Informed consent must be given before the emergency situation occurs
Who cannot participate:
- People under 18 years old
- Pregnant or breastfeeding women
- Anyone with a history of severe allergic reactions to the study medications
- People with certain medical conditions that might interfere with study results
- Those currently participating in another clinical trial
- Anyone who has recently used medications that might affect the study results
- People with a history of substance abuse or addiction
- Those unable to provide informed consent
What the trial involves:
The study is testing three medications: dexmedetomidine (administered as a film that dissolves under the tongue), lorazepam (taken as an oral tablet), and midazolam (given as a solution absorbed through the lining of the mouth). Participants receive a single dose of one medication, and their agitation levels are monitored at 30, 60, 90, and 120 minutes after the dose. The main goal is to measure the change in agitation score at 60 minutes. Researchers also track how quickly patients become calm or fall asleep, whether additional medication or physical restraint is needed within 12 hours, and patient satisfaction with the treatment.
Investigational drugs:
Dexmedetomidine is given as a single dose under the tongue for quick absorption. It works by activating receptors in the brain that help calm the nervous system. Lorazepam is taken as an oral tablet and serves as a standard treatment for comparison. It increases the activity of a neurotransmitter that reduces anxiety and agitation. Midazolam is administered inside the cheek for rapid absorption and enhances brain chemicals that promote relaxation. All three medications belong to classes known for their sedative and calming effects.
Evaluation of lorazepam, pregabalin, and olanzapine in treating agitated behavior in dementia patients who did not respond to standard treatments
This study focuses on nursing home residents with dementia who experience agitated behavior that has not improved with standard treatments. The trial tests three medications to determine how well they control agitation symptoms.
Who can participate:
- Adults aged 18 years or older
- Nursing home residents with diagnosed dementia
- Those showing signs of agitated behavior such as restlessness, aggression, or increased activity
- People whose treating physician has already decided to prescribe quetiapine, olanzapine, or lorazepam
- The decision to use medication must have been made between the patient or their legal representative and their doctor, independent of the research study
- Participants must be able to provide consent themselves or have a legal representative who can consent on their behalf
Who cannot participate:
- People with a history of severe allergic reactions to psychiatric medications
- Those with other serious mental health conditions besides dementia
- People with severe liver or kidney problems
- Those currently participating in other clinical trials
- Anyone unable to comply with study procedures or follow-up visits
- People using medications that could interact with the study drugs
- Those with uncontrolled high blood pressure or severe heart conditions
- Anyone with a history of substance abuse within the past 6 months
- People with severe neurological conditions other than dementia
- Pregnant or breastfeeding women
- Those with legal incapacity or limited legal capacity to consent
- People with terminal illness and life expectancy less than 12 months
- Anyone with severe communication difficulties that prevent proper assessment
- Those with blood disorders that could affect medication safety
- People who have had major surgery within the past 3 months
What the trial involves:
The study runs from May 2025 to May 2027. Participants receive either quetiapine, olanzapine, lorazepam, or a placebo (an inactive substance) in capsule form for 6 weeks. Maximum daily doses are 50mg for quetiapine, 10mg for olanzapine, or 2mg for lorazepam. All capsules look identical so neither patients nor healthcare providers know which treatment is being given. Agitated behavior is monitored using the Cohen Mansfield Agitation Inventory, which tracks changes in agitation levels. Additional assessments measure the severity and improvement of symptoms, and any side effects are documented throughout the treatment period.
Investigational drugs:
The trial tests psychotropic medications, which are drugs that affect brain function, behavior, and mood. These medications are being studied as alternatives for patients who have not responded to conventional treatments. They work by altering brain chemistry to help manage symptoms like aggression, restlessness, and emotional outbursts. The specific medications tested belong to a category not currently included in standard treatment guidelines for dementia-related agitation.
Summary
Two clinical trials are currently investigating treatments for agitation in different patient populations. The first trial in Denmark focuses on emergency psychiatric care for acute agitation in adults, comparing three medications with different administration methods. The second trial in the Netherlands targets nursing home residents with dementia whose agitation has not responded to standard treatments.
Both studies test medications that affect brain chemistry to calm agitated behavior, but they address different medical contexts. The Danish trial seeks rapid treatment options for acute psychiatric emergencies, while the Dutch trial explores longer-term management of behavioral symptoms in dementia patients. Interestingly, lorazepam appears in both trials, suggesting its potential role across different types of agitation.
These trials represent important efforts to improve care for people experiencing agitation, whether in emergency situations or as part of chronic conditions like dementia. The research aims to identify the most effective and safe treatment options for these challenging clinical situations.
