title: Rapid onset of treatment effects on psychosis, depression, and mania in patients with acute exacerbation of schizoaffective disorder following treatment with oral extended-release paliperidone.
abstract: BACKGROUND
  Patients with schizoaffective disorder (SCA) experience complicated interplays of psychotic, depressive, and manic symptoms. Paliperidone extended-release (pali ER) tablets have been shown to be efficacious in these patients, but treatment response has not been studied relative to the onset of effects for these symptom domains.
  
  
  METHODS
  In a pooled analysis of data from two 6-week, randomized, placebo-controlled studies, the onset of treatment effects with oral pali ER was evaluated by symptom domain (psychosis, depression, mania) in patients with an acute SCA exacerbation. Subjects were categorized as having prominent psychotic (Positive and Negative Syndrome Scale score >70), depressive (Hamilton Rating Scale for Depression-21 score ≥16), or manic (Young Mania Rating Scale score ≥16) symptoms at baseline.
  
  
  RESULTS
  Of the 614 patients in these analyses, 597 (97.2%), 411 (66.9%), and 488 (79.5%) had prominent psychotic, depressive, and manic symptoms at baseline, respectively. Pali ER treatment was associated with rapid and significant improvement of all three symptom domains versus placebo within 1 week of initiation, regardless of whether treatment was given as monotherapy or in combination with mood stabilizers and/or antidepressants. Adverse events were similar to those reported in the original published studies.
  
  
  CONCLUSIONS
  This post hoc analysis of two phase 3 trials requires confirmation in prospective studies.
  
  
  CONCLUSIONS
  This pooled analysis suggests that treatment with pali ER is associated with rapid control of psychotic, depressive, and manic symptoms in patients with SCA. Its findings support the benefit of pali ER as a primary treatment for the management of SCA.
authors.affiliation: Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road-A32404, Titusville, NJ 08560, USA. Electronic address: dfu@its.jnj.com.
authors.forename: Dong-Jing
authors.initials: DJ
authors.lastname: Fu
authors.affiliation: Janssen Research & Development, Titusville, NJ, USA.
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Turkoz
authors.affiliation: Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road-A32404, Titusville, NJ 08560, USA.
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Bossie
authors.affiliation: Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road-A32404, Titusville, NJ 08560, USA.
authors.forename: Hiren
authors.initials: H
authors.lastname: Patel
authors.affiliation: Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road-A32404, Titusville, NJ 08560, USA.
authors.forename: Larry
authors.initials: L
authors.lastname: Alphs
mesh_terms: D000284:Administration, Oral; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000150:complications / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003863:Depression / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011618:Psychotic Disorders / Q000150:complications* / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D000068882:Paliperidone Palmitate
keywords: Depression; Mania; Onset; Paliperidone; Psychosis; Schizoaffective disorder