title: Treatment with paliperidone in children with behavior disorders previously treated with risperidone:  an open-label trial.
abstract: OBJECTIVE
  Paliperidone is the main active metabolite of risperidone, with certain pharmacokinetic and tolerability characteristics that suggest it may be used in special groups, such as children. Our purpose is to document the clinical experience with the use of paliperidone in children with severe behavior problems that were partially refractory to treatment with risperidone and psychological treatment.
  
  
  METHODS
  This is a prospective 16-week open-label study of paliperidone in 18 patients (mean age, 13.4 years) with severe and excessive irritability in the context of generalized developmental disorders or attention-deficit/hyperactivity disorder. Patients who had exhibited an inadequate response to treatment with risperidone (1.5-2 mg/d) over a treatment period of 6 months were treated with paliperidone at 3 mg/d. Symptom severity at the beginning of the study and in response to paliperidone were rated with the Clinical Global Impression (CGI) scale and Overt Aggression Scale.
  
  
  RESULTS
  A significant difference was documented between the mean score before treatment and the score after the drug intervention with paliperidone. There was a noticeable clinical improvement in 50% of the cases, as reflected in the CGI. Severity of aggressive behavior, as assessed by the Overt Aggression Scale, decreased significantly after paliperidone treatment: mean (SD), 2.7 (0.92) before treatment versus 1.5 (0.60) after treatment. This compound was safe and well tolerated.
  
  
  CONCLUSIONS
  Half of the patients clearly responded to paliperidone extended release. Tolerance to this treatment was distinctly better than to risperidone. These preliminary results lay the foundation for further research into the use of paliperidone to treat pediatric disruptive behavior disorders within the context of randomized, double-blind, controlled clinical trials.
authors.affiliation: Neuropediatrics Section, Hospital Universitario Quirón Madrid, Pozuelo de Alarcón, Madrid, Spain. dmfmayor@yahoo.es
authors.forename: Daniel Martín
authors.initials: DM
authors.lastname: Fernández-Mayoralas
authors.forename: Alberto
authors.initials: A
authors.lastname: Fernández-Jaén
authors.forename: Nuria
authors.initials: N
authors.lastname: Muñoz-Jareño
authors.forename: Beatriz
authors.initials: B
authors.lastname: Calleja-Pérez
authors.forename: Ana Laura
authors.initials: AL
authors.lastname: Fernández-Perrone
authors.forename: Sonia López
authors.initials: SL
authors.lastname: Arribas
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000188:drug therapy* / Q000523:psychology*; D002648:Child; D002675:Child, Preschool; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D002658:Developmental Disabilities / Q000188:drug therapy / Q000523:psychology; D057915:Drug Substitution / Q000379:methods; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage*; D008297:Male; D000068882:Paliperidone Palmitate; D010865:Pilot Projects; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage*; D018967:Risperidone / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D007555:Isoxazoles; D011743:Pyrimidines; D018967:Risperidone; D000068882:Paliperidone Palmitate