Baseline | Acute phase | Follow-up period | |||||
---|---|---|---|---|---|---|---|
V0 | V1 | V2 | V3 | V4 | V5 | ||
D-30 to D-7 | D-7 to D0 | D1 to D5 | D5 to D10 | D 35 ± 3 | D 90 ± 7 | D 180 ± 7 | |
Screening eligibility, demography, medical and psychiatrica history, treatment, pregnancy testb | X | ||||||
Written informed consent and enrolment | X | ||||||
PANSS evaluation | X | X | X | X | X | X | |
Randomizationc | X (D1) | ||||||
Drug toxicology screening and AP | X | ||||||
Physical and clinical examination | X | X | X | X | X | ||
hf-tRNS sessionsd | X | ||||||
FTND | X | X | X | ||||
SNS | X | X | X | ||||
AHRS, HCS, PSAS, CDSS, CGI | X | X | X | X | X | ||
MRIe, SGI, source memoryf | X | X | |||||
Blood samplesg | X (D1) | ||||||
FARh | X | X (D1) | X | ||||
SQoL-18 | X | X | |||||
BNSS | X | X | X | ||||
MARS, BMQs, SUMD | X | X | |||||
Medication deviationi, AE | X | X | X | X | X | X |