In reply
Thank you for the opportunity to respond to the "Letter to the Editor"
that Dr Jagadheesan has written. Dr Jagadheesan correctly identifies a clear
protocol violation associated with enrollment of a patient who did not meet
the minimum Y-MRS requirement. Please note that in our analysis, however,
adherence to the intent-to-treat principle motivates inclusion of this patient
as randomized even though inclusion criteria for manic symptoms severity were
not followed in this one instance.