Midazolam for Acute agitation

Inclusion criteria

• {"criterion_text":"- 18-64 years\n- Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms\n- Total score of ≥14 on the PANSS Excited Component (PEC)\n- A score ≥4 on at least 1 of the 5 items of the PEC\n- Informed consent obtained prior to the occurrence of the emergency"}

Exclusion criteria

• {"criterion_text":"- Involuntary psychiatric admission according to the Danish Mental Health Act\n- 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\n- Known allergy to any of the study medications\n- Female patients who are breastfeeding\n- Female patients aged <50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives\n- Body weight <50 kg\n- Extreme obesity defined as estimated BMI≥ 40 kg/m2\n- Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator)\n- The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator)\n- 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)\n- 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"}

Primary endpoints

• {"endpoint_text":"- PANSS Excited Component (PEC) score at 60 minutes post-dose (change from pre- to post-dose)","definition_or_measurement_approach":"Change from pre-dose to 60 minutes post-dose on the PANSS Excited Component (PEC) score"}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Change from baseline PEC score assessed at 30, 60, 90, and 120 minutes to determine earliest statistically significant difference"}
• {"endpoint_text":"- Proportion tranquillized or asleep (measured as ≤4 on the BARS**) by 30, 60, 90, and 120 minutes post-dose","definition_or_measurement_approach":"Proportion of participants with BARS score ≤4 at 30, 60, 90, and 120 minutes post-dose"}
• {"endpoint_text":"- Proportion physically restrained from administration to 12 hours post-dose","definition_or_measurement_approach":"Proportion of participants physically restrained between administration and 12 hours post-dose"}
• {"endpoint_text":"- Proportion mechanically restrained from administration to 12 hours post-dose","definition_or_measurement_approach":"Proportion of participants mechanically restrained between administration and 12 hours post-dose"}
• {"endpoint_text":"- Proportion given rescue medication 4-12 hours post-dose","definition_or_measurement_approach":"Proportion of participants who receive rescue medication during the 4–12 hour post-dose window"}
• {"endpoint_text":"- Patient-reported satisfaction measured using 4 items from the Treatment Satisfaction Questionnaire for Medication II","definition_or_measurement_approach":"Patient-reported satisfaction using 4 items from TSQM II"}

Denmark

Earliest CTIS Part Ii Submission Date

14-05-2024

Latest Decision Or Authorization Date

10-06-2024

Processing Time Days

27

Number Of Sites

1

Number Of Participants

132

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsorDuties codes: 1, 12","organisation_type":"Regulatory Authority"}