Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry
Overview
- Phase
- Phase 2
- Intervention
- Sublingual Dexmedetomidine
- Conditions
- Agitation
- Sponsor
- Lone Baandrup
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- The Excited Component of the Positive and Negative Syndrome Scale (PEC)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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?
Investigators
Lone Baandrup
Head of Clinic, clinical associate research professor
University of Copenhagen
Eligibility Criteria
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
Arms & Interventions
Sublingual dexmedetomidine
Intervention: Sublingual Dexmedetomidine
Buccal midazolam
Intervention: Buccal midazolam
Oral lorazepam
Intervention: Oral lorazepam
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Physical restraint(12 hours post-dose)
- PEC score earliest time with difference(30, 60, 90, and 120 minutes)
- Tranquillized or asleep(30, 60, 90, and 120 minutes post-dose)
- Mechanical restraint(12 hours post-dose)
- Rescue medication(4-12 hours post-dose)
- Patient-reported satisfaction(From 2 to 24 hrs post-dose when the participant is able to cooperate)