AgitationPhase 2/3NCT06752616
Acute Agitation in Emergency Psychiatry
A Phase 2/3 study testing Sublingual Dexmedetomidine, Buccal midazolam and Oral lorazepam in people with Agitation, run by Lone Baandrup at 1 site in Denmark.
Trial summary
The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Agitation
- What is being tested?
- Sublingual Dexmedetomidine, Buccal midazolam and Oral lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Dec 2024to Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Center Copenhagen, Bispebjerg
Copenhagen N, 2400
Lone Baandrup, 0045 91165903, lone.baandrup@regionh.dk
Marie Vang, MD
About this study
Official title: Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry
The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.
Read the detailed description
The initial treatment of acute agitation aims to reduce suffering, abort the immediate risk of harm to self or others, and prevent the use of coercive measures such a physical and mechanical restraint. With this research project, we aim to build the initial structure of a visionary platform design and to examine the efficacy, tolerability, and safety of two hitherto under-investigated compounds versus the current standard of care for acutely agitated patients when de-escalation techniques have failed. After obtaining the results of the initial phase, we plan to apply for future funding to maintain and expand the platform design with the addition of relevant experimental arms. The proposed platform design aims to anwer the question What is the best treatment for acutely agitated patients in inpatient psychiatric settings?
- Conditions
- Agitation
- Being tested
- Sublingual Dexmedetomidine, Buccal midazolam, Oral lorazepam
- Keywords
- Emergency psychiatry
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual DexmedetomidineDrug
Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs
Buccal midazolamDrug
Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs
Oral lorazepamDrug
Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs
| Study group | Role | What they receive |
|---|---|---|
| Sublingual dexmedetomidine | Experimental | Not described Receives: Drug: Sublingual Dexmedetomidine |
| Buccal midazolam | Experimental | Not described Receives: Drug: Buccal midazolam |
| Oral lorazepam | Active comparator | Not described Receives: Drug: Oral lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Excited Component of the Positive and Negative Syndrome Scale (PEC)
The Excited Component of the Positive and Negative Syndrome Scale (PEC) consists of 5 clinician-rated items associated with agitation from the Positive and Negative Syndrome Scale (PANSS). Scores range from 5 to 35. Higher is worse.
Measured: 60 minutes
Secondary outcomes (6)
PEC score earliest time with difference
The earliest time where a statistically significant difference in agitation is apparent as measured by change from baseline PEC score (change from pre- to post-dose PEC score at 30, 60, 90, and 120 minutes)
Measured: 30, 60, 90, and 120 minutes
Tranquillized or asleep
Proportion tranquillized or asleep (measured as ≤4 on the BARS**) by 30, 60, 90, and 120 minutes post-dose
Measured: 30, 60, 90, and 120 minutes post-dose
Physical restraint
Proportion physically restrained from administration to 12 hours post-dose
Measured: 12 hours post-dose
Mechanical restraint
Proportion mechanically restrained from administration to 12 hours post-dose
Measured: 12 hours post-dose
Rescue medication
Proportion given rescue medication 4-12 hours post-dose
Measured: 4-12 hours post-dose
Patient-reported satisfaction
Patient-reported satisfaction measured using 4 items from the Treatment Satisfaction Questionnaire for Medication II. Each item is answered on a 7-point Likert scale from 1 (extremely dissatisfied) to 7 (extremely satisfied). Score range is from 4 to 28. Higher is better.
Measured: From 2 to 24 hrs post-dose when the participant is able to cooperate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start30 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lone Baandrup
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark
- Responsible party
- Sponsor-investigator, Lone Baandrup, University of Copenhagen
- Investigators
- Lone Baandrup, MD, DMSc, Principal investigator, Mental Health Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752616
- Sponsor's protocol ID
- 2023-510201-18-00
- Other IDs
- 2023
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be available in the CTIS. After publication of primary and secondary outcomes, IPD will be handed over to the Danish National Archives where data will be archived for 25 years. IPD will be shared upon reasonable reuqest after publication of primary and secondary outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry
- ClinicalTrials.gov ID
- NCT06752616
- Acronym / sponsor ID
- 2023-510201-18-00
- Conditions
- Agitation
- Keywords
- Emergency psychiatry
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Lone BaandrupUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.
Detailed description
The initial treatment of acute agitation aims to reduce suffering, abort the immediate risk of harm to self or others, and prevent the use of coercive measures such a physical and mechanical restraint. With this research project, we aim to build the initial structure of a visionary platform design and to examine the efficacy, tolerability, and safety of two hitherto under-investigated compounds versus the current standard of care for acutely agitated patients when de-escalation techniques have failed. After obtaining the results of the initial phase, we plan to apply for future funding to maintain and expand the platform design with the addition of relevant experimental arms. The proposed platform design aims to anwer the question What is the best treatment for acutely agitated patients in inpatient psychiatric settings?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sublingual dexmedetomidine | Experimental | Drug: Sublingual Dexmedetomidine |
| Buccal midazolam | Experimental | Drug: Buccal midazolam |
| Oral lorazepam | Active comparator | Drug: Oral lorazepam |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sublingual DexmedetomidineSublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs | Drug | Sublingual dexmedetomidine |
| Buccal midazolamBuccal midazolam 10 mg, possible second dose 10 mg after 2 hrs | Drug | Buccal midazolam |
| Oral lorazepamOral lorazepam 4 mg, possible second dose 4 mg after 2 hrs | Drug | Oral lorazepam |
Primary outcome
The Excited Component of the Positive and Negative Syndrome Scale (PEC)
Time frame: 60 minutes
The Excited Component of the Positive and Negative Syndrome Scale (PEC) consists of 5 clinician-rated items associated with agitation from the Positive and Negative Syndrome Scale (PANSS). Scores range from 5 to 35. Higher is worse.
6 secondary outcomes
PEC score earliest time with difference
Time frame: 30, 60, 90, and 120 minutes
Tranquillized or asleep
Time frame: 30, 60, 90, and 120 minutes post-dose
Physical restraint
Time frame: 12 hours post-dose
Mechanical restraint
Time frame: 12 hours post-dose
Rescue medication
Time frame: 4-12 hours post-dose
Patient-reported satisfaction
Time frame: From 2 to 24 hrs post-dose when the participant is able to cooperate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: Yes. The study protocol will be available in the CTIS. After publication of primary and secondary outcomes, IPD will be handed over to the Danish National Archives where data will be archived for 25 years. IPD will be shared upon reasonable reuqest after publication of primary and secondary outcomes.
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Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
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Nabilone for Agitation Blinded Intervention Trial
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Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lone Baandrup, MD, DMSc principal investigator
Mental Health Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sublingual Dexmedetomidine, Buccal midazolam and Oral lorazepam in people with Agitation, run by Lone Baandrup at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lone Baandrup, MD, DMSc (00 45 91165903, lone.baandrup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Excited Component of the Positive and Negative Syndrome Scale (PEC) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.