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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Sublingual Dexmedetomidine

    Drug

    Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs

  • Buccal midazolam

    Drug

    Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs

  • Oral lorazepam

    Drug

    Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs

Treatment groups

132 Participants
are divided into 3 treatment groups
Group A: Sublingual dexmedetomidineExperimental treatment 1 intervention
Group B: Buccal midazolamExperimental treatment 1 intervention
Group C: Oral lorazepamActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Excited Component of the Positive and Negative Syndrome Scale (PEC)

The Excited Component of the Positive and Negative Syndrome Scale (PEC) consists of 5 clinician-rated items associated with agitation from the Positive and Negative Syndrome Scale (PANSS). Scores range from 5 to 35. Higher is worse.

Time frame
60 minutes

Secondary outcomes

1

PEC score earliest time with difference

The earliest time where a statistically significant difference in agitation is apparent as measured by change from baseline PEC score (change from pre- to post-dose PEC score at 30, 60, 90, and 120 minutes)

Time frame
30, 60, 90, and 120 minutes
2

Tranquillized or asleep

Proportion tranquillized or asleep (measured as ≤4 on the BARS\*\*) by 30, 60, 90, and 120 minutes post-dose

Time frame
30, 60, 90, and 120 minutes post-dose
3

Physical restraint

Proportion physically restrained from administration to 12 hours post-dose

Time frame
12 hours post-dose
4

Mechanical restraint

Proportion mechanically restrained from administration to 12 hours post-dose

Time frame
12 hours post-dose

Other outcomes

Locations

1

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

Mental Health Center Copenhagen, BispebjergRecruiting2400, Copenhagen NDenmarkDenmark

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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