CTIS2023-510201-18-00
Active, not recruiting
Phase 1
Advancing the quality of treatment and care for acute agitation in emergency psychiatry
Psykiatrisk Center Kobenhavn0 sites132 target enrollmentMarch 15, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Psykiatrisk Center Kobenhavn
- Enrollment
- 132
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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