Defining and validating bipolar disorder in the preschool period

The validation of the MAThy S scale was the primary outcome of this 24-week, phase III, open-label, olanzapine single-arm clinical trial.

“Endpoint” refers to the last non-missing observation in Study Period II (acute phase endpoint) or III (overall endpoint) (Additional file : Figure A).(Marseille, France) and conducted according to applicable laws and regulations, Good Clinical Practice (as defined by the International Conference on Harmonisation), and the Declaration of Helsinki.The study was assigned the Clinical identifier NCT#002592722.Patients at risk of suicide (according to the investigator’s opinion and 17-item Hamilton Depression Rating Scale (HAMD-17) item 3 Suicide ≥3 were also excluded.Patients signed and dated the informed consent document before entering the study. The screening period (Study Period I) of 0 to 8 days was followed by the 6-week acute phase (Study Period II) with one visit per week for the first 3 weeks (Visits 1 to 5).

Defining and validating bipolar disorder in the preschool period