Improving Treatment for Acute Agitation in Psychiatric Emergency Care Comparing New Medications to Standard Therapy for Adults 18 to 64 Years

What this Trial Is About

Researchers are evaluating treatments for acute agitation in psychiatric patients when de-escalation methods do not work. The study aims to find the best medication to reduce suffering and prevent harm or the use of restraints in emergency psychiatric settings. This research focuses on two less-studied drugs compared to the current standard care. The plan includes building a platform to test new treatments and improve care quality for agitated patients. The study tests three medication options sublingual dexmedetomidine, buccal midazolam, and oral lorazepam. Each drug may be given with a possible second dose two hours later. Participants are randomly assigned to one of these treatments without masking. The goal is to compare how well these drugs control agitation in hospital psychiatric settings. Participants will be monitored for agitation levels using the Excited Component of the Positive and Negative Syndrome Scale PEC at multiple times after dosing. Researchers will also track whether patients become calm or asleep, the use of physical or mechanical restraints, rescue medications, and patient satisfaction within 24 hours after treatment. The study runs until December 2027 and involves regular assessments during the inpatient stay to evaluate safety and treatment effects.

Acute Agitation in Emergency Psychiatry