Dataset from A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia

The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an
intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients
with schizophrenia

The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject
to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole
monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be
stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in
Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are
eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During
Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending
relapse for up to 38 weeks.