title: Paliperidone palmitate versus oral antipsychotics in recently diagnosed schizophrenia.
abstract: OBJECTIVE
  Relapse and acute exacerbation are common in schizophrenia and may impact treatment response and outcome. Evidence is conflicting in respect to superiority of long-acting injectable antipsychotic therapies versus oral antipsychotics in relapse prevention. This randomized controlled study assessed the efficacy of paliperidone palmitate versus oral antipsychotics for relapse prevention.
  
  
  METHODS
  Eligible patients with a recent diagnosis of schizophrenia (within 1-5 years) were randomized 1:1 to paliperidone palmitate (n=376) or oral antipsychotic monotherapy (n=388) and entered a 2-week initial acute oral treatment phase. Patients who met predefined response criteria were eligible to enter the 24-month rater-blinded core treatment phase. Patients were evaluated for relapse, symptoms, functioning, quality of life, treatment satisfaction, and tolerability.
  
  
  RESULTS
  In the core treatment phase, time to relapse was significantly longer in the paliperidone palmitate (n=352) compared with the oral antipsychotics arm (n=363): 85% of patients were relapse-free at 469 versus 249 days (P=0.019). Significantly fewer patients receiving paliperidone palmitate met the relapse criteria (52 [14.8%] versus 76 [20.9%, oral antipsychotics]; P=0.032), representing a 29.4% relative risk reduction. For paliperidone palmitate, a significantly greater improvement in Positive and Negative Syndrome Scale total score on Day 8 (P=0.021) and a trend at endpoint (P=0.075) were observed. Functioning improvements were comparable between treatment arms. No new safety signals were identified.
  
  
  CONCLUSIONS
  The observed time to relapse superiority of paliperidone palmitate over oral antipsychotics provides further evidence for the value of long-acting injectable antipsychotic therapies in the treatment of schizophrenia, including during the early stages of illness.
authors.affiliation: Medical Affairs, Janssen Cilag EMEA, Neuss, Germany. Electronic address: aschrein@its.jnj.com.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schreiner
authors.affiliation: North Estonia Medical Centre Foundation, Tallinn, Estonia.
authors.forename: Kaire
authors.initials: K
authors.lastname: Aadamsoo
authors.affiliation: Department of Psychiatry, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
authors.forename: A Carlo
authors.initials: AC
authors.lastname: Altamura
authors.affiliation: Psychiatric Department, Zamora Hospital, Zamora, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Franco
authors.affiliation: Hôpital Sainte-Anne, Paris Descartes University (INSERM U894), France.
authors.forename: Philip
authors.initials: P
authors.lastname: Gorwood
authors.affiliation: St Petersburg V.M. Bekhterev Psychoneurological Research Institute, St Petersburg, Russia.
authors.forename: Nikolaj G
authors.initials: NG
authors.lastname: Neznanov
authors.affiliation: Welgemoed Medical Centre, Cape Town, South Africa.
authors.forename: Juan
authors.initials: J
authors.lastname: Schronen
authors.affiliation: Istanbul Medical Faculty, Istanbul, Turkey.
authors.forename: Alp
authors.initials: A
authors.lastname: Ucok
authors.affiliation: Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
authors.forename: Mathias
authors.initials: M
authors.lastname: Zink
authors.affiliation: Global Clinical Operations, Janssen-Cilag, Warsaw, Poland.
authors.forename: Adam
authors.initials: A
authors.lastname: Janik
authors.affiliation: Medical Affairs, Janssen Cilag EMEA, Issy-les-Moulineaux, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Cherubin
authors.affiliation: Biostatistics, Janssen Cilag Benelux, Tilburg, The Netherlands.
authors.forename: Marjolein
authors.initials: M
authors.lastname: Lahaye
authors.affiliation: Medical Affairs, Janssen Cilag EMEA, Neuss, Germany.
authors.forename: Ludger
authors.initials: L
authors.lastname: Hargarter
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate / Q000008:administration & dosage*; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D000068882:Paliperidone Palmitate
keywords: Long-acting injectable and oral antipsychotics; Paliperidone palmitate; Randomized controlled trial; Recently diagnosed; Relapse prevention; Schizophrenia