Assessments | SC | BL Visit 1 W 0 | Visit 2 W 1 | Visit 3 W 2 | Visit 4 W 3 | Visit 5 W 4 | Visit 6 W 6 | Visit 7 W 8 | Visit 8 W 10 | FU Visit 9 W 12 |
---|---|---|---|---|---|---|---|---|---|---|
Screening and consent | ||||||||||
Inclusion/exclusion criteria | X | |||||||||
Informed consent | X | |||||||||
Physical examination1 | X | X | ||||||||
Prior and concomitant medi-cation and non-drug therapy | X | X | X | X | X | X | X | X | X | X |
Medical history | X | |||||||||
IMP dispersion | X | X | X | X | X | X | X | |||
IMP return | X | X | X | X | X | X | X | |||
Safety | ||||||||||
Blood test2 | X | X | ||||||||
Cannabis test | X | |||||||||
Pregnancy test | X | X | X | X | X | X | X | |||
ECG | X | X | (X)3 | |||||||
Blood pressure, pulse | X | X | X | X | X | X | X | X | X | X |
Weight | X | X | X | X | X | |||||
Adverse event recording | X | X | X | X | X | X | X | X | X | |
Effectiveness | ||||||||||
Primary | ||||||||||
CAPS-IV B2 | X | |||||||||
Secondary | ||||||||||
CAPS-IV B2 | X | X | X | X | X | X | X | X | ||
CAPS-5 | Xa | Xb | Xb | Xb | ||||||
PSQI-A | X | X | X | |||||||
MADRS | X | X | X | X | ||||||
Sleep diary | X | X | X | X | X | X | X | X | ||
PCL-5 | X | X | X | |||||||
BSL-23 | X | X | X | |||||||
EQ-5D | X | X | X | |||||||
PGIC | X | X | ||||||||
SOFAS | X | X | X | |||||||
PSQI | X | X | X | |||||||
ITQ | X | X | X | |||||||
MWC | X | X | X | X | ||||||
Others | ||||||||||
Demographics | X | |||||||||
CTQ | X | |||||||||
MINI-5 | X | |||||||||
ITI | X |