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

Phase 1

• Conditions: acute agitation; Therapeutic area: Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

• Registration Number: CTIS2023-510201-18-00
• Lead Sponsor: Psykiatrisk Center Kobenhavn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

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, Informed consent obtained prior to the occurrence of the emergency

Exclusion Criteria

Involuntary psychiatric admission according to the Danish Mental Health Act, 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, Known allergy to any of the study medications, 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, Extreme obesity defined as estimated BMI= 40 kg/m2, Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator), The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator), 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), 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified