Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate

Table 1 Schedule of study assessments

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		XX	XX	X**
Up to 3 mg/day lorazepam or alprazolam	X
Up to 2 mood-stabilisers allowed	X	X	X	X	X	X

*day -1 after informed consent.
Number of ‘X’ represents number of assessments (X* 15 mg methylphenidate vs. placebo, X** 20 mg methylphenidate vs. placebo).

ISSN: 1471-244X