Study period (SP) | SP I (screening/ washout) | SP II (double-blind treatment) | SP III (down-titration) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit number: | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | Unscheduled visitsa | Early discontinuation |
(End of) week: | −2 | −1 | 0 | 1 | 2 | 4 | 6 | 8 | 12 | 13 | ||
Suggested time to next visit (days): | 7 | 7 | 7 | 7 | 14 | 14 | 14 | 28 | 7 | |||
Allowable time to next visit (days): | 5–9 | 5–9 | 5–9 | 5–9 | 10 - 18 | 10–18 | 10–18 | 24–32 | 5–9 | |||
Clinical assessments: | ||||||||||||
Informed consent/assent | X | |||||||||||
Psychiatric assessment | X | |||||||||||
Systematic Interview, e.g. DISC (OCD group) | X | |||||||||||
Systematic Interview, e.g. DISC (re co-morbidities): ODD, CD, tic domains (all patients) | X | |||||||||||
ADI-R short version, (ASD group) | X | |||||||||||
WIS-C (4 subtests) | X | |||||||||||
Inclusion/exclusion criteria | X | X | X | |||||||||
Randomisation to active drug vs. placebo | X | |||||||||||
Demographics | X | |||||||||||
Physical examination | X | |||||||||||
Medical history | X | |||||||||||
Discontinuation of prohibited medications | X | |||||||||||
Height, weight, vital signs | X | X | X | |||||||||
Clinical laboratory testsb,c, | X | Xc | X | Xc | (X)a | Xc | ||||||
Serum and urine pregnancy testd | X | |||||||||||
Urine drug screen | X | (X)a | X | |||||||||
Urine analysis | X | X | X | X | X | |||||||
Biomarkers | X | |||||||||||
Genetics | X | |||||||||||
Physical Development Scale | X | X | ||||||||||
CGI-S | X | X | X | X | X | X | X | X | X | X | ||
CGI-I | X | X | X | X | X | X | X | X | ||||
C-GAS | X | X | X | X | ||||||||
CBCL, 6–18 | X | |||||||||||
CY-BOCS | X | X | X | X | X | X | X | X | (X)a | X | ||
Children’s Social Behaviour Questionnaire | X | X | X | X | X | X | X | X | (X)a | X | ||
Repetitive Behaviour Scale-Revised (RBS-R), | X | X | X | X | X | X | X | X | (X)a | X | ||
CHIP-CE/AE | X | X | X | X | ||||||||
PAERS | X | X | X | X | X | X | X | X | X | X | ||
Neuropsychological test battery | X | X | X | |||||||||
Neuroimaging assessments | X | X | ||||||||||
AE monitoring | X | X | X | X | X | X | X | X | X | X | X | |
Concomitant medications | X | X | X | X | X | X | X | X | X | X | X | X |
Eligibility to remain in study | X | X | X | X | X | X | X | X | X | X | X | |
Study drug dispensed | X | X | X | X | X | X | X | |||||
Study drug returned | X | X | X | X | X | X | X |