Agitation
Conditions
Keywords
Emergency psychiatry
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?
Interventions
Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs
DRUGBuccal midazolam
Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs
DRUGOral lorazepam
Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs
Sponsors
Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital
Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark
Lone Baandrup
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Excited Component of the Positive and Negative Syndrome Scale (PEC) | 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
| Measure | Time frame | Description |
|---|---|---|
| Tranquillized or asleep | 30, 60, 90, and 120 minutes post-dose | Proportion tranquillized or asleep (measured as ≤4 on the BARS\*\*) by 30, 60, 90, and 120 minutes post-dose |
| Physical restraint | 12 hours post-dose | Proportion physically restrained from administration to 12 hours post-dose |
| PEC score earliest time with difference | 30, 60, 90, and 120 minutes | 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) |
| Rescue medication | 4-12 hours post-dose | Proportion given rescue medication 4-12 hours post-dose |
| Patient-reported satisfaction | From 2 to 24 hrs post-dose when the participant is able to cooperate | 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. |
| Mechanical restraint | 12 hours post-dose | Proportion mechanically restrained from administration to 12 hours post-dose |
Countries
Denmark
Contacts
Primary ContactLone Baandrup, MD, DMSc
Backup ContactMarie Vang Jensen, MD
Outcome results
None listed