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.
Tohen M, Risser R, Grundy SL. Olanzapine in Acute Bipolar Mania. Arch Gen Psychiatry. 2002;59(2):186. doi: