Acute Agitation in Emergency Psychiatry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-30

Study Completion Date

2027-12-31

Brief Summary

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The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.

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Detailed Description

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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

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Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sublingual dexmedetomidine

Group Type EXPERIMENTAL

Sublingual Dexmedetomidine

Intervention Type DRUG

Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs

Buccal midazolam

Group Type EXPERIMENTAL

Buccal midazolam

Intervention Type DRUG

Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs

Oral lorazepam

Group Type ACTIVE_COMPARATOR

Oral lorazepam

Intervention Type DRUG

Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs

Interventions

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Sublingual Dexmedetomidine

Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs

Intervention Type DRUG

Buccal midazolam

Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs

Intervention Type DRUG

Oral lorazepam

Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No