Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial

Schizophr Res. 2007 Feb;90(1-3):147-61. doi: 10.1016/j.schres.2006.09.012. Epub 2006 Nov 7.


Background: Paliperidone extended-release tablet (paliperidone ER) is an investigational oral psychotropic developed for schizophrenia treatment. It utilizes OROS technology to provide a unique pharmacokinetic profile, eliminating the need for titration and potentially leading to improved tolerability. Furthermore, paliperidone undergoes limited hepatic metabolism.

Methods: The efficacy and safety of once-daily paliperidone ER (6 mg, 9 mg and 12 mg) were assessed versus placebo in 628 patients with acute schizophrenia in a 6-week, multicenter, double-blind, randomized, parallel-group study.

Results: All doses of paliperidone ER demonstrated significant improvement in PANSS score, all PANSS Marder factor scores (p<0.001) and personal and social functioning versus placebo (p<0.001). The PANSS total score also improved significantly in the olanzapine treatment arm. Significantly higher percentages of paliperidone ER patients demonstrated a > or =30% reduction in PANSS total score versus placebo (p<0.001). The incidence of movement disorder-related AEs and rating scales measurements were similar to placebo for the paliperidone ER 6 mg group and higher in the 9 mg and 12 mg groups. In the paliperidone ER groups there were no reports of glucose-related AEs or clinically relevant changes in plasma lipid levels and changes in mean bodyweight<1 kg.

Conclusion: In this study, all doses of paliperidone ER were effective in significantly improving the symptoms of schizophrenia and personal and social functioning and were generally well tolerated. Paliperidone ER offers a distinctive treatment profile and may provide a valuable new treatment option for patients with schizophrenia.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antipsychotic Agents / administration & dosage*
  • Delayed-Action Preparations
  • Dose-Response Relationship, Drug
  • Drug-Related Side Effects and Adverse Reactions
  • Dyskinesia, Drug-Induced / etiology
  • Female
  • Humans
  • Isoxazoles / administration & dosage*
  • Male
  • Middle Aged
  • Paliperidone Palmitate
  • Patient Dropouts
  • Psychiatric Status Rating Scales
  • Pyrimidines / administration & dosage*
  • Randomized Controlled Trials as Topic
  • Schizophrenia / drug therapy*
  • Schizophrenic Psychology
  • Sleep Initiation and Maintenance Disorders / chemically induced
  • Tachycardia / chemically induced
  • Treatment Outcome


  • Antipsychotic Agents
  • Delayed-Action Preparations
  • Isoxazoles
  • Pyrimidines
  • Paliperidone Palmitate