acute agitation
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PANSS Excited Component (PEC) score at 60 minutes post-dose (change from pre- to post-dose) | — |
Secondary
| Measure | Time 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