Procedures | Visit 1 Screening | Visit 2 PLACEBO | Visit 3 Randomisation Day 0 Scopolamine or placebo | Visit 4 Day 4 (± 2 days) Scopolamine or placebo | Visit 5 Day 8 (± 2 days) Scopolamine or placebo | Visit 6 Day 15 (± 5 days) Follow-Up | Visit 7 Day 29 (± 7 days) Follow-Up | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
IV infusion | IV infusion | IV infusion | IV infusion | ||||||||||||
Pre | During | Post | Pre | During | Post | Pre | During | Post | Pre | During | Post | ||||
Signed informed consent | X | ||||||||||||||
Inclusion/exclusion | X | X | X | ||||||||||||
Randomisation | X | ||||||||||||||
IWRS | X | X | X | ||||||||||||
Demography | X | ||||||||||||||
MEHI | X | ||||||||||||||
Medical/surgical history/history BPD | X | ||||||||||||||
Current medication | X | X | X | X | X | X | X | ||||||||
Vital signs—HR, BP, and RR | X | X | X | X | X | X | X | X | X | ||||||
SCID-RV | X | ||||||||||||||
HDRS | X | X | X | X | X | X | X | ||||||||
YMRS | X | X | X | X | X | X | X | ||||||||
AUDIT | X | ||||||||||||||
Pregnancy discussion | X | X | X | X | X | ||||||||||
Contraception advice | X | X | X | X | X | ||||||||||
Serum pregnancy testΔ | X | ||||||||||||||
Pregnancy urine dipstickΔ | X | X | X | X | |||||||||||
U&Es, LFTs, TFTs° | X | X | |||||||||||||
Fagerstrom | X | ||||||||||||||
CGI-S | X | X | X | X | X | X | |||||||||
CGI-I | X | X | X | X | X | ||||||||||
VAS | X | X | X | X | X | X | X | X | |||||||
MADRS | X | X | X | X | X | X | |||||||||
GAF | X | X | X | X | |||||||||||
ECG | X | ||||||||||||||
Height (cm) and weight (kg) | X | ||||||||||||||
IV cannulation | X | X | X | X | |||||||||||
Infusion administration | X | X | X | X | |||||||||||
Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
Cannulation site check | X | X | X | X | X | X | X | X | |||||||
POMS (optional) | X | X | X | X | X | X | X | X | X | X | |||||
CANTAB b (optional) | X | X | X | ||||||||||||
WAIS a (optional) | Xa | Xa | Xa | Xa | Xa | Xa | |||||||||
NEO-PI-FFI a (optional) | Xa | Xa | Xa | Xa | Xa | Xa | |||||||||
PRISE (optional) | X | X | X | X | |||||||||||
Subjective assessment | X |