Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 64Years
All Genders
NCT06752616

Acute Agitation in Emergency Psychiatry

Led by Lone Baandrup · Updated on 2025-01-01

132

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

L

Lone Baandrup

Lead Sponsor

U

University Hospital Bispebjerg and Frederiksberg

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.

CONDITIONS

Official Title

Acute Agitation in Emergency Psychiatry

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 64 years
  • Agitation requiring tranquilization in inpatient psychiatric settings including emergency rooms
  • Total score of at least 14 on the PANSS Excited Component (PEC)
  • A score of 4 or higher on at least one of the five PEC items
  • Informed consent given before the emergency occurs
Not Eligible

You will not qualify if you...

  • Involuntary psychiatric admission under the Danish Mental Health Act
  • Female patients who are breastfeeding
  • Females under 50 years who cannot confirm a negative pregnancy test and safe contraceptive use
  • Body weight less than 50 kg
  • Extreme obesity with body mass index of 40 kg/m2 or higher
  • Situations where antipsychotic drugs are preferred for acute agitation treatment
  • Unwillingness or inability to cooperate with study procedures
  • Insufficient language skills to read, write, or provide informed consent in Danish or other available languages
  • Suspected contraindications for any treatment arms
  • Use of benzodiazepines, sedatives, or antipsychotics within 4 hours before study treatment
  • Known allergy to any study medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mental Health Center Copenhagen, Bispebjerg

Copenhagen N, Denmark, 2400

Actively Recruiting

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Research Team

L

Lone Baandrup, MD, DMSc

CONTACT

M

Marie Vang Jensen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Acute Agitation in Emergency Psychiatry | DecenTrialz