INTRODUCTION
schizophrenia
Poor treatment adherence associated with frequent relapses along with functional deterioration is a characteristic feature in the clinical course of schizophrenia (Paliperidone palmitate, an atypical/second-generation antipsychotic, is a LAI formulation of paliperidone that is currently available as 1-month (PP1M), 3-month (PP3M), and 6-month (PP6M) injectable formulations. Both PP1M and PP3M have previously demonstrated efficacy in symptom control, relapse prevention, and reduction in hospitalizations in patients with schizophrenia (A recent global phase 3, randomized, double-blind (DB), active-controlled, relapse prevention study (hereafter referred to as DB study) demonstrated noninferiority of PP6M (700 and 1000 mg eq. doses) to PP3M (350 and 525 mg eq. doses) in preventing relapse in participants with schizophrenia previously stabilized on PP1M or PP3M. The DB study suggested a comparable efficacy of PP6M with its 3-month counterpart (PP3M) for participants who remained relapse free at the end of the 12-month DB treatment. Safety findings for PP6M were consistent with the known profile of paliperidone palmitate in this study, and no new concerns specific for PP6M were identified (The current study is a 2-year, single-arm, open-label extension (NCT03345342; hereafter referred to as open-label extension [OLE] study) of the DB study and was aimed to evaluate the long-term efficacy and safety of PP6M in participants who remained relapse free in the DB study.