Examination/evaluation | Screening | Treatment | Follow up | |||
---|---|---|---|---|---|---|
Day | -2/-1 | 0 | 1 | 2 | 3 | 9 |
Review Inclusion/Exclusion criteria | X | |||||
Informed consent | X | |||||
Randomisation | *X | (X) | ||||
General | ||||||
Medical and psychiatric history | X | |||||
Demographics and illness characteristics | X | |||||
Physical examination | X | |||||
Vital signs | X | X | X | X | X | X |
Blood analysis | X | X | X | |||
Urine analysis, drug screening | X | X | ||||
Pregnancy test | *X | |||||
Concomitant medication | X | X | X | X | X | |
Baseline findings/adverse events | X | X | X | X | X | |
ECG | X | X | X | |||
ADHD-Screening | X | |||||
Efficacy | ||||||
YMRS | X | XX | X | X | X | X |
CGI-BP | X | X | X | X | ||
PANSS-EC | XXXXX | X | X | X | X | |
EEG | X | X | ||||
Actigraphy | *X | X | X | X | ||
Cognitive test | X | X | X | |||
Medication | ||||||
Study drug: methylphenidate, placebo | X*X* | X**X** | X** | |||
Up to 3 mg/day lorazepam or alprazolam | X | |||||
Up to 2 mood-stabilisers allowed | X | X | X | X | X | X |