- Outpatients who have completed double-blind therapy in short-term study for the
indication of major depressive disorder (MDD), including scheduled evaluations, with
no major protocol violations and no study events that, in the opinion of the
investigator, would preclude the subject's entry into the long-term, open-label study.
- Clinically important abnormalities on baseline (day 56 of the short-term study)
physical examination, or any unresolved clinically significant abnormalities on
electrocardiogram (ECG), laboratory test results, or vital signs recorded before day
56 in the previous short-term study for the indication of MDD.