The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs
Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs
Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs
Mental Health Center Copenhagen, Bispebjerg
Copenhagen N, Denmark
RECRUITINGThe 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.
Time frame: 60 minutes
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)
Time frame: 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
Time frame: 30, 60, 90, and 120 minutes post-dose
Physical restraint
Proportion physically restrained from administration to 12 hours post-dose
Time frame: 12 hours post-dose
Mechanical restraint
Proportion mechanically restrained from administration to 12 hours post-dose
Time frame: 12 hours post-dose
Rescue medication
Proportion given rescue medication 4-12 hours post-dose
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From 2 to 24 hrs post-dose when the participant is able to cooperate