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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510201-18-00
Enrollment
132
Registered
2024-06-10
Start date
2024-12-27
Completion date
Unknown
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute agitation

Brief summary

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

Detailed description

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

Interventions

DRUGLorazepam Orion 1 mg tabletter
DRUGMidazolam Medical Valley 10 mg munhålelösning
DRUGIgalmi

Sponsors

Psykiatrisk Center Kobenhavn
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026