A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone palmitate (R092670); Risperidone
Intervention description: Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.; Risperidone LAI intramuscular at a dose of 25 mg on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
Intervention MeSH terms: Risperidone; Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 452.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone; Paliperidone palmitate; Risperidone; Risperidone long acting injection; R092670

Summary:

      The purpose of this study is to compare the efficacy of paliperidone palmitate and
      risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric
      disorder with symptoms of emotional instability, detachment from reality, often with
      delusions and hallucinations, and withdrawal into the self) along with safety and
      tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who meet diagnostic criteria for schizophrenia according to Diagnostic
             and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (disorganized type
             [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or
             undifferentiated type [295.90]) for at least 1 year before screening and prior medical
             records, written documentation, or verbal information obtained from previous
             psychiatric providers obtained by the investigator must be consistent with the
             diagnosis of schizophrenia

          -  A total Positive and Negative Syndrome Scale (PANSS) score between 60 and 120,
             inclusive, at screening and baseline

          -  Body mass index (BMI) of equal to or greater than 17.0 kilogram per meter square
             (kg/m^2)

          -  Female participants must be postmenopausal for at least 2 years, surgically sterile,
             abstinent, or, if sexually active, be practicing an effective method of birth control
             before study entry and throughout the study

          -  Be capable of self-administering study medication (applies to oral supplementation) or
             have assistance with study medication administration consistently available throughout
             the first 4 weeks of the study Exclusion Criteria:

          -  A primary, active DSM-IV diagnosis on Axis I other than schizophrenia

          -  A decrease of at least 25 percent in the total PANSS score between screening and
             baseline

          -  Participants who have previously participated in this study

          -  A DSM-IV diagnosis of active substance dependence within 3 months before screening
             (nicotine and caffeine are not exclusionary)

          -  History of treatment resistance as defined by failure to respond to 2 adequate
             treatments with different antipsychotic medications (an adequate treatment is defined
             as a minimum of 6 weeks at maximum tolerated dosage)