Procedure | Pre-treatment period | Post-treatment evaluation period | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Screeninga (up to 4 h) | Baseline (within 30 min prior to dose 1) | Time 0 | 1 h | 2 h | 4 h | 24 h or end of the agitation episode, whichever occurs first | ||||||
0 min | 10 min | 20 min | 30 min | 50 min | 60 min | 90 min | 120 min | 240 min | ||||
Informed consentb | X | |||||||||||
Inclusion/exclusion criteria | X | Xc | ||||||||||
Demographics | X | |||||||||||
Medical history | X | |||||||||||
Pre-dose medications | Xd | Xd | ||||||||||
Physical examinatione | X | X | ||||||||||
Urine pregnancy test (females of child-bearing potential)f | X | |||||||||||
Randomisation | X | |||||||||||
Study drug administration | X | ← NOT ALLOWED → | Up to 1 dose PRNg | |||||||||
CGI-S Scaleh | X | |||||||||||
CGI-I Scaleh | X ± 2 min | X ± 2 min | X ± 2 min | X ± 2 min | X ± 5 min | X ± 5 min | X ± 5 min | X ± 1 h | ||||
TSQM (Item 14)h | X | X | ||||||||||
Vital signsh,i | X | X | X | X | X | |||||||
AEsj | X→ | → | → | → | → | → | → | → | → | X | ||
Concomitant medicationsk | X→ | → | → | → | → | → | → | → | → | → | →k | Xk |
Discharge from the study | X |