Advancing the quality of treatment and care for acute agitation in emergency psychiatry

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstaden

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

Trial duration

27 Dec 2024 → ongoing

Decision date (initial)

2024-06-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Independent Research Fund Denmark (DFF Grant ID: 10.46540/3166-00037B)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To examine the efficacy of a single dose sublingual dexmedetomidine versus oral lorazepam, and the efficacy of a single dose buccal midazolam versus oral lorazepam for acute tranquillization.

Secondary objectives 1

1. To examine the effectiveness, tolerability, safety, and patient-reported satisfaction of a single dose sublingual dexmedetomidine versus oral lorazepam and of a single dose buccal midazolam versus oral lorazepam for acute tranquillization.

Conditions and MedDRA coding

acute agitation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 18-64 years
2. Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms
3. Total score of ≥14 on the PANSS Excited Component (PEC)
4. A score ≥4 on at least 1 of the 5 items of the PEC
5. Informed consent obtained prior to the occurrence of the emergency

Exclusion criteria 11

1. Involuntary psychiatric admission according to the Danish Mental Health Act
2. Female patients who are breastfeeding
3. Female patients aged <50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives
4. Body weight <50 kg
5. Extreme obesity defined as estimated BMI≥ 40 kg/m2
6. Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator)
7. The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator)
8. Insufficient language skills that interfere with reading, writing, and providing written informed consent in Danish or other available languages (in the opinion of the investigator)
9. Clinical suspicion of contraindications for one of the treatment arms: severe hepatic impairment, hypotension (systolic blood pressure <90 mmHg), bradycardia (heart rate <60 bpm), 2nd or 3rd degree atrioventricular block in patients without pacemaker, severe ventricular dysfunction, known QTc prolongation, respiratory impairment (need for oxygen supplementation to keep SpO2≥92% or SpO2≥88% in patients with COPD), and sleep apnea
10. Use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usual treatment (i.e., additional PN sedative prescriptions) in the 4 hours before study treatment
11. Known allergy to any of the study medications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PANSS Excited Component (PEC) score at 60 minutes post-dose (change from pre- to post-dose)

Secondary endpoints 6

1. 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)
2. Proportion tranquillized or asleep (measured as ≤4 on the BARS**) by 30, 60, 90, and 120 minutes post-dose
3. Proportion physically restrained from administration to 12 hours post-dose
4. Proportion mechanically restrained from administration to 12 hours post-dose
5. Proportion given rescue medication 4-12 hours post-dose
6. Patient-reported satisfaction measured using 4 items from the Treatment Satisfaction Questionnaire for Medication II

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation

Region Hovedstaden

Address

Esther Ammundsens Vej 36

City

Copenhagen Nv

Postcode

2400

Country

Denmark

Scientific contact point

Organisation

Psykiatrisk Center Kobenhavn

Contact name

Lone Baandrup

Public contact point

Organisation

Psykiatrisk Center Kobenhavn

Contact name

Lone Baandrup

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications