A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.
Condition: Schizophrenia
MeSH terms: Recurrence; Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy (effectiveness) and safety of
      paliperidone ER compared with placebo in the prevention of recurrence of symptoms of
      schizophrenia.
    

Detailed description: 
      Paliperidone ER is currently being investigated as treatment for the acute symptoms of
      schizophrenia and also as maintenance treatment. This trial is designed to evaluate efficacy
      and safety of paliperidone ER in prevention of recurrence of psychotic symptoms in patients
      with schizophrenia. This trial is a randomized (patients will be assigned to different
      treatment groups based solely on chance), double-blind (neither the patient nor the physician
      will know if placebo or drug is being given and at what dose), placebo-controlled,
      parallel-group, multicenter study consisting of 5 phases: a screening phase of up to 5 days;
      a 8-week open-label run-in phase, during which all patients will be treated with open-label,
      flexibly dosed paliperidone ER (3 to 15 mg) orally once daily to identify a dose that will
      achieve control of their acute psychotic symptoms (only patients who maintain a stable dosage
      regimen and have a total Positive and Negative Syndrome Scale [PANSS] score </=70; Clinical
      Global Impression Scale - Severity [CGI-S] </=4; and scores of </=4 for PANSS items for
      delusions, conceptual disorganization, hallucinatory behavior, suspiciousness/persecution,
      hostility, and uncooperativeness during the last 2 weeks of the run-in phase will be eligible
      to continue in the stabilization phase); a 6-week open-label stabilization phase, patients
      who maintain control of their acute psychotic symptoms at the paliperidone ER dosage
      identified during the run-in phase and meet the total PANSS score, CGI-S, and PANSS items
      scores throughout the stabilization phase will be randomized to receive either flexibly dosed
      paliperidone ER, starting at the dose maintained during the stabilization phase of the study,
      or placebo; a double-blind treatment phase of variable duration, during which patients will
      be followed until they meet either defined criteria for recurrence or the study ends; a
      52-week open-label extension phase for patients who experience a recurrence event during the
      double-blind phase of the study, or who remain recurrence free for the entire double-blind
      phase of the study. Efficacy will be assessed using the PANSS and CGI-S scores that will be
      collected every week, every 2 weeks, or every 4 weeks throughout. Safety assessments include
      the incidence of adverse events throughout the study; measurement of vital signs (orthostatic
      pulse rate, orthostatic blood pressure, and temperature); and clinical laboratory tests. In
      the run-in, double-blind, and open-label extension phases of the study, paliperidone ER or
      matching placebo will be flexibly dosed in the range 3 to 15 mg orally once a day (3, 6, 9,
      12, or 15 mg/day). The dosage in the stabilization phase will be fixed throughout at the
      dosage that achieved symptom control in the run-in phase.
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; paliperidone; Risperidone