Health Trials

Acute Agitation in Emergency Psychiatry

ConditionAgitation
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorLone Baandrup

About this trial

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

Eligibility criteria

Qualifiers

18-64 years

Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms

Total score of ≥14 on the PANSS Excited Component (PEC)

A score ≥4 on at least 1 of the 5 items of the PEC

Disqualifiers

Involuntary psychiatric admission according to the Danish Mental Health Act

Female patients who are breastfeeding

Female patients aged <50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives

Body weight <50 kg

Trial design

Treatments tested in this trial

  • Sublingual Dexmedetomidine
  • Buccal midazolam
  • Oral lorazepam

Treatment groups

132 Participants
are divided into 3 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Mental Health Center Copenhagen, BispebjergRecruiting2400, Copenhagen NDenmarkDenmark

Sponsors and collaborators

Lone Baandrup

Lead sponsor

University of Copenhagen

Sponsor institution

University Hospital Bispebjerg and Frederiksberg

Collaborator

Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark

Collaborator

Source ClinicalTrials.gov