title: Efficacy and Tolerability of Paliperidone Extended-release in the Treatment of First-episode Psychosis: An Eight-week, Open-label, Multicenter Trial.
abstract: OBJECTIVE
  We investigated the efficacy and tolerability of paliperidone extended-release (ER) tablets in patients with first-episode psychosis (n=75).
  
  
  METHODS
  This was an 8-week, open-label, multicenter trial. The primary outcome variable was scores on the Positive and Negative Syndrome Scale (PANSS); secondary measures included the Scale for the Assessment of Negative Symptoms (SANS), the Cognitive Assessment Interview (CAI), and the Global Assessment of Functioning (GAF). To assess safety, we measured drug-related adverse events, weight, lipid-related variables, and prolactin and administered the Simpson-Angus Rating Scale (SARS), the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Scale (BAS), the Arizona Sexual Experiences Scale (ASEX), and the Udvalg for Kliniske Undersogelser side effect rating scale (UKU).
  
  
  RESULTS
  The administration of paliperidone ER resulted in significant improvement in the PANSS, SANS, CAI, and GAF scores (p＜0.001) over time. This improvement was evident as early as 1 week. The most frequent adverse events were akathisia, somnolence, anxiety, and sedation, which were well tolerated. Modest increases in weight and lipid profiles were also noted. Prolactin levels were substantially increased at the endpoint in both male and female patients.
  
  
  CONCLUSIONS
  These results indicate that paliperidone ER is effective and is characterized by good tolerability in the treatment of positive and negative symptoms and cognitive functioning in first-episode psychosis.
authors.affiliation: Department of Psychiatry, Maeumsarang Hospital, Wanju, Korea.
authors.forename: Nam-In
authors.initials: NI
authors.lastname: Kang
authors.affiliation: Department of Psychiatry, Yeungnam University, Gyeongsan, Korea.
authors.forename: Bon-Hoon
authors.initials: BH
authors.lastname: Koo
authors.affiliation: Department of Psychiatry, Chonnam National University Medical School, Gwangju, Korea.
authors.forename: Sung-Wan
authors.initials: SW
authors.lastname: Kim
authors.affiliation: Department of Psychiatry, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, Korea.
authors.forename: Jong-Hoon
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Psychiatry, Konkuk University School of Medicine, Cheongju, Korea.
authors.forename: Beomwoo
authors.initials: B
authors.lastname: Nam
authors.affiliation: Department of Psychiatry, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.
authors.forename: Bong-Ju
authors.initials: BJ
authors.lastname: Lee
authors.affiliation: Department of Psychiatry, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
authors.forename: Sang-Hyuk
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Department of Psychiatry, Kyoungpook National University School of Medicine, Daegu, Korea.
authors.forename: Seung Jae
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: Department of Psychiatry, Inje University Ilsan Paik Hospital, Goyang, Korea.
authors.forename: Seung-Hwan
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Department of Psychiatry, Hallym University Sacred Heart Hospital, Anyang, Korea.
authors.forename: Myung Hun
authors.initials: MH
authors.lastname: Jung
authors.affiliation: Department of Psychiatry, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.
authors.forename: Sang Woo
authors.initials: SW
authors.lastname: Hahn
authors.affiliation: Department of Psychiatry, Chonbuk National University Hospital, Jeonju, Korea.|Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Korea.
authors.forename: Young-Chul
authors.initials: YC
authors.lastname: Chung
keywords: Efficacy; First-episode psychosis; Paliperidone extended-release; Tolerability