A Study of Paliperidone Palmitate 6-Month Formulation
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: PP6M injection Dose 1; PP6M injection Dose 2
Intervention description: Participants will receive Dose 1 PP6M intramuscular (IM) injection at Visit 1 (Day) then once every 6 month up to 24 months.; Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to assess the long-term safety and tolerability of
      paliperidone 6-month PP6M (Dose 1 or Dose 2 [milligram] mg eq.) and to provide access to PP6M
      in participants with schizophrenia completing the R092670PSY3015 study without relapse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the Double-blind Phase of Study R092670PSY3015 without relapse and continue
             to be willing to be treated with paliperidone palmitate 6 month injection (PP6M)

          -  Must, in the opinion of the investigator, be able to continue treatment at the same
             dose level (moderate or higher dose) as used during the Double-blind Phase of Study
             R092670PSY3015 at the time of screening for this study

          -  A woman of childbearing potential: a) Must have a negative pregnancy test on Day 1; b)
             Use contraception consistent with local regulations. A man must agree that during the
             study and for a minimum 12 months after receiving the last dose of the study
             intervention: a) His female partner(s) will use highly effective method pf
             contraception

          -  Sign an informed consent form (ICF) indicating that he or she understands the purpose
             of, and procedures required for, the study and is willing to participate in the study;
             and must be able to provide his or her own consent (that is, consent cannot be
             provided by a legal representative of the participant)

          -  In the opinion of the investigator, the patient would be able to participate for the
             duration of this study

        Exclusion Criteria:

          -  Has any condition for which, in the opinion of the investigator, participation would
             not be in the best interest of the participant (example, compromise the well-being) or
             that could prevent, limit, or confound the protocol-specified assessments

          -  Completed R092670PSY3015 while presenting adverse events deemed clinically relevant by
             the investigator, and which may interfere with safety and well-being of the
             participant

          -  If a man, has plans to father a child while enrolled in this study or within 12 months
             after the last dose of study intervention. Must not, if a woman, have plans to become
             pregnant while enrolled in this study or within 12 months after the last dose of study
             intervention