NCT06752616

Acute Agitation in Emergency Psychiatry

Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Lone Baandrup · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Agitation

Interventions

Type	Name	Description
DRUG	Sublingual Dexmedetomidine	Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs
DRUG	Buccal midazolam	Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs
DRUG	Oral lorazepam	Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs

Timeline

• Start date: 2024-12-30
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-12-30
• Last updated: 2025-01-01

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated drug study