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Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry
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?
Age
18 - 64 years
Sex
ALL
Healthy Volunteers
No
Mental Health Center Copenhagen, Bispebjerg
Copenhagen N, Denmark
Start Date
December 30, 2024
Primary Completion Date
December 1, 2027
Completion Date
December 1, 2027
Last Updated
January 1, 2025
132
ESTIMATED participants
Sublingual Dexmedetomidine
DRUG
Buccal midazolam
DRUG
Oral lorazepam
DRUG
Lead Sponsor
Lone Baandrup
Collaborators
NCT04516057
NCT06808984
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05522647