Table 1.
Study course
| Assessment criteria | Visit 1 | Visit 2 | Visit 3 |
|---|---|---|---|
| Demographic data (sex, age, body height, and body weight) | X | – | – |
| Concomitant therapy due to inclusion diagnosis | X | – | – |
| Concomitant medication in general and due to inclusion diagnosis | X | – | – |
| Efficacy and tolerability of previous therapy due to inclusion diagnosis | X | – | – |
| Impairment to everyday life of the family by child’s complaints (filled in by legal guardian; visual analogue scale; 0 = no limitation; 10 = extreme limitation) | X | X | X |
| CBCL/4-18 (filled in by legal guardian) | X | X | X |
| Common symptoms such as learning disorders, speech disorders, lack of concentration, school/examination anxieties, other anxiety disorders, aggressiveness/irritability, depression, uncoordinated hyperkinesia, tiredness/fatigue, problems falling asleep, problems staying asleep, headache, and abdominal/stomach pain (filled in by physician; 0 = nothing; 3 = strong) | X | X | X |
| Drug changes (newly prescribed, withdrawn, dosage decreased, and dosage increased) | X | X | |
| Tolerability | – | X | X |
| Adverse drug reactions | – | X | X |
CBCL child behavior checklist