Efficacy and safety of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 52-week open-label studies
- 1 November 2008
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in International Clinical Psychopharmacology
- Vol. 23 (6), 343-356
- https://doi.org/10.1097/yic.0b013e328314e1f3
Abstract
Long-term efficacy and safety of paliperidone extended-release tablets (3-12 mg/day) were evaluated in pooled data from 52-week open-label extension (OLE) phases of three 6-week, placebo-controlled, double-blind (DB) trials involving 1083 schizophrenia patients. Forty-seven percent of patients completed the OLE phase. Outcome measures included Positive and Negative Syndrome Scale and Personal and Social Performance scale scores. Improvements observed on both scales in active treatment groups during the DB phases were maintained during the OLE phase. Most commonly (≥ 10% patients) reported adverse events (AEs) were insomnia, headache, and akathisia. One or more serious AEs were reported by 16% of patients; two patients had a treatment-emergent AE that resulted in death (suicide). Extrapyramidal symptom-related AEs were reported by 25% of patients. Median maximum movement disorder rating scale scores indicated no severity change during the OLE. Mean (± SD) increase in body weight from OLE baseline to end point was 1.1 ± 5.47 kg across treatment groups and there were no clinically meaningful changes for plasma glucose, insulin or lipid levels. This analysis shows that paliperidone extended-release can maintain improvements in symptoms and functioning and is generally well tolerated for up to 52 weeks in schizophrenia patients. © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins.ArticlKeywords
This publication has 34 references indexed in Scilit:
- A multicentre, randomized, naturalistic, open-label study between aripiprazole and standard of care in the management of community-treated schizophrenic patients Schizophrenia Trial of Aripiprazole: (STAR) studyEuropean Psychiatry, 2007
- Guided Discontinuation Versus Maintenance Treatment in Remitted First-Episode PsychosisThe Journal of Clinical Psychiatry, 2007
- Defining ‘Response’ in Antipsychotic Drug Trials: Recommendations for the Use of Scale-Derived CutoffsNeuropsychopharmacology, 2007
- Paliperidone Extended-Release Tablets for Prevention of Symptom Recurrence in Patients With SchizophreniaJournal of Clinical Psychopharmacology, 2007
- What does the PANSS mean?Schizophrenia Research, 2005
- Response and Relapse in Patients With Schizophrenia Treated With Olanzapine, Risperidone, Quetiapine, or HaloperidolThe Journal of Clinical Psychiatry, 2005
- Current Issues in SchizophreniaCNS Drugs, 2004
- Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social funtioningActa Psychiatrica Scandinavica, 2000
- Dr. Nemeroff and the Publishers ReplyThe Journal of Clinical Psychiatry, 1997
- A RATING SCALE FOR EXTRAPYRAMIDAL SIDE EFFECTSActa Psychiatrica Scandinavica, 1970