A Study of Paliperidone Palmitate 6-Month Formulation
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: PP6M; PP3M 350 mg eq.; PP3M 525 mg eq.; PP1M; Placebo
Intervention description: Participants will receive intramuscular injection of PP6M.; Participants will receive intramuscular injection of PP3M 350 mg eq.; Participants will receive intramuscular injection of PP3M 525 mg eq.; Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.; Participants will receive matching placebo.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 841.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate that injection cycles consisting of a single
      administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2
      sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg
      eq.) for the prevention of relapse in participants with schizophrenia previously stabilized
      on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M
      (350 or 525 mg eq.).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must meet the diagnostic criteria for schizophrenia according to Diagnostic and
             Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months
             before screening

          -  Must be receiving treatment with paliperidone palmitate (as either the paliperidone
             palmitate 1-month (PP1M) or paliperidone palmitate 3-month (PP3M) formulation), or
             injectable risperidone, or any oral antipsychotic

          -  Must be able, in the opinion of the investigator, to discontinue any antipsychotic
             medication other than PP1M) or PP3M during the Screening Phase

          -  Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than (<)
             70 points at screening

          -  Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter (m)^2
             (inclusive) and must have a body weight of at least 47 kg at screening

          -  Must be willing to receive gluteal injections of medication during the Double-blind
             Phase

        Exclusion Criteria

          -  Must not be receiving any form of involuntary treatment, such as involuntary
             psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment

          -  Must not have attempted suicide within 12 months before screening and must not be at
             imminent risk of suicide or violent behavior, as clinically assessed by the
             investigator at the time of screening

          -  Must not have a DSM-5 diagnosis of moderate or severe substance use disorder (except
             for nicotine and caffeine) within 6 months of screening; however, acute or
             intermittent substance use prior to screening is not exclusionary, depending upon the
             clinical judgment of the investigator

          -  Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia

          -  Must not have a history of intolerability or severe reactions to moderate or higher
             doses of antipsychotic medications and must not have any other factors that would, in
             the judgment of the investigator, indicate that treatment with moderate or higher
             doses of paliperidone palmitate would be intolerable or unsafe