Study of TV-46000 for Maintenance Treatment of Schizophrenia

Study Description

Primary objectives:
- The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000.
- The primary safety and tolerability endpoint is the frequency of Female, Male adverse events, including serious adverse events.
- For new patients, the total duration of patient participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage [Stage 1], a 56-week double-blind maintenance stage [Stage 2], and a follow-up period [8 weeks]).
- For roll-over patients, the total duration of patient participation in the study is planned to be up to 64 weeks (including up to 56 weeks in the maintenance stage [Stage 2] and a follow-up period [8 weeks]).
- Patients who started Stage 2 who relapse or meet 1 or more of the withdrawal criteria should be invited to perform the Early Termination visit as soon as possible within 4 weeks of the last injection.
- Patients who withdraw from the study before completing the 56-week maintenance stage will have follow-up procedures and assessments performed at their follow-up visits. During the follow-up period, patients will be treated according to the investigator's judgment.
- Female, Male subjects will be treated with active drug.