T0 | T1 Week 1 | T2 Week 12/24 ± 14 days | T3 Week 24/36 ± 14 days | T4 Week 36/48 ± 14 days | |
---|---|---|---|---|---|
Assessment for eligibility | Study visit: Baseline | Study visit: After step 1 | Study visit: After step 2 | Study visit: Follow-up | |
Screening and inclusion/exclusion criteria | X | ||||
Informed consent | X | ||||
Drug screening | Xa | Xa | b | b | b |
Medical history | X | ||||
Pregnancy test (urine) | X | Xa | c | c | c |
IDA-R Interview | X | X | X | X | X |
CGI | X | X | X | X | |
WRAADS | X | X | X | X | |
IQ (WST) | X | ||||
M.I.N.I. | X | ||||
WFIRS | X | X | X | X | |
SCL-90-S | X | X | X | X | |
AAQoL-29 | X | X | X | X | |
CTQ | X | ||||
PSQI | X | X | X | X | |
STAXI-2 | X | X | X | X | |
QB Test | X | X | X | X | |
TMS | X | X | X | X | |
EEGd | X | X | |||
Adherence | X | ||||
List comorbiditye | X | X | X | X | X |
Socioeconomic status | X | X | X | X | X |
Psychopathology and comorbid conditionse in short study visits during step 1 | Week 4 and 8; for waiting list group additionally in week 16 and 20 | ||||
Psychopathology and comorbid conditionse in short study visits during step 2 | Week 16 and 20; for waiting list group additionally in week 28 and 32 | ||||
Safety assessmentse during step 2 for methylphenidate treatment | Week 13, 14, 15, 16, 18, 20 and 22, while waiting list group will undergo these safety assessments three months later (week 25, 26, 27, 28, 30, 32 and 34) | ||||
Adverse events according psychiatric adverse events (PAEs) | Weekly/biweekly between T2 and T3 |