Analysis
The Full Analysis Set (FAS) consists of all patients of the randomised population who receive at least one dose of treatment in either group regardless of protocol deviations. All analyses will be conducted on the FAS unless otherwise specified. Supportive analyses on the Per Protocol (PP) analysis set will be conducted for the primary outcome. The PP consists of all patients of the FAS who complete the study and do not have major protocol violations.
The primary endpoint (mean change from baseline in the YMRS total score at day 2) will be analyzed by ANCOVA. Covariables include sex, age and severity of illness at baseline. Secondary efficacy measures such as change in YMRS total score from baseline at day 2, drop-out rates, or the relationship between the stability of vigilance regulation before treatment and response to methylphenidate as well as the effects of methylphenidate on the vigilance regulation will be analyzed using descriptive statistics. The statistical hypothesis test of the primary and secondary variables will be used at a significance level of 0.05 (two-sided).
Statistical evaluations will be performed by using SPSS® Version PASW 20.