A Study of the Efficacy (Effectiveness) of Paliperidone Palmitate in the Prevention of Recurrence of the Symptoms of Schizophrenia.
Condition: Schizophrenia
MeSH terms: Recurrence; Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of paliperidone palmitate compared with
      placebo in the prevention of recurrence of the symptoms of schizophrenia and to assess the
      safety and tolerability of paliperidone palmitate in patients with stable and symptomatic
      schizophrenia. The placebo used in this study was a nutritional substance known as 20%
      Intralipid emulsion given to patients requiring intravenous feedings.
    

Detailed description: 
      Many patients with schizophrenia have difficulty adhering to a daily oral treatment regimen.
      Long-acting injectable formulations, such as long-acting injectable paliperidone palmitate,
      may provide therapeutic plasma concentrations over several weeks, thereby eliminating the
      need for daily oral medication and making compliance easier. This study 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 followed by an
      open-label extension period in patients with schizophrenia. The study is designed to evaluate
      the efficacy of paliperidone palmitate (a long-acting injectable formulation) in delaying the
      time to and decreasing the rate of recurrence compared with placebo in patients with
      schizophrenia. The study will consist of 5 periods: an up to 7-day
      screening/washout/tolerability period, a 9-week open-label transition period, a 24-week
      open-label maintenance period, a randomized, variable-length double-blind, placebo-controlled
      recurrence prevention period, and an up to 52-week open-label extension period. Patients will
      have intramuscular (i.m.) study drug injections and efficacy and safety evaluations performed
      every 4 weeks throughout the study. Efficacy will be evaluated during the study using a
      recurrence assessment, the Positive and Negative Symptom Scale for Schizophrenia (PANSS), the
      Clinical Global Impression - Severity (CGI-S) scale, and the Personal and Social Performance
      (PSP) scale. Safety will be assessed throughout the study by monitoring adverse events; use
      of extrapyramidal symptoms (EPS) rating scales (Abnormal Involuntary Movement Scale [AIMS],
      Barnes Akathisia Rating Scale [BARS], Simpson Angus Scale [SAS]); clinical laboratory
      testing; vital signs (temperature, blood pressure, and heart rate) measurements;
      electrocardiograms (ECGs); and physical examinations. Additionally, the patients will assess
      the tolerability of the injections by evaluating the pain of the injection and the pain at
      the injection sites. Tolerability test: 3 mg/day of oral ER OROS paliperidone for 4 days.
      Transition (9 wks): 50 mg eq. paliperidone palmitate i.m. dose on Day 1, then i.m. injections
      (25, 50, or 100 mg eq.) once every 4 wks (q4wk). Maintenance (24-wks): paliperidone palmitate
      i.m. injections (25, 50, or 100 mg eq.) q4wk. Recurrence Prevention: paliperidone palmitate
      i.m. injections (25, 50, or 100 mg eq. or placebo) q4wk. Open-label paliperidone palmitate
      (25, 50, 75, or 100 mg eq.) q4wk for 12 dosing periods.
    

Intervention name(s): Placebo; Paliperidone Palmitate
Intervention type(s): Drug; Drug
Intervention description(s): Placebo every 4 wk up to 24 mo; 25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Schizophrenia; Paliperidone palmitate; R092670; antipsychotic; recurrence prevention