PMID- 16768634
OWN - NLM
STAT- MEDLINE
DCOM- 20061107
LR  - 20211018
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 16
IP  - 3
DP  - 2006 Jun
TI  - Long-term use of risperidone in children with disruptive behavior disorders and 
      subaverage intelligence: efficacy, safety, and tolerability.
PG  - 260-72
AB  - OBJECTIVE: The aim of this study was to assess the long-term efficacy and 
      tolerability of risperidone in the treatment of children and adolescents with 
      disruptive behavior disorder (DBD) and below-average intelligence (IQ < 84) over 
      a cumulative period of 2 years. METHODS: We followed 48 patients (6-15 years of 
      age), who had previously completed a 1- year open-label study of risperidone, for 
      an additional year of treatment. Efficacy was assessed using the conduct problem 
      subscale of the Nisonger Child Behavior Rating Form (N-CBRF) as a primary outcome 
      measure; other N-CBRF subscales, the Aberrant Behavior Checklist (ABC), and the 
      Clinical Global Impression (CGI) of severity were secondary efficacy measures. 
      Safety and tolerability were also assessed. RESULTS: Of the 48 patients enrolled 
      in this extension study, 33 (69%) completed the trial. The efficacy benefits from 
      the original study were maintained over the course of the extension study. Safety 
      and tolerability were good overall, with the number of adverse events (AEs) 
      decreasing in the extension trial, compared to the original trial. Six patients 
      (13%) discontinued owing to AEs. Weight gain observed in the original trial 
      stabilized during this extension trial. Cognitive testing demonstrated small, but 
      significant, improvements in cognitive ability. CONCLUSIONS: Risperidone is safe 
      and effective in treating DBDs in children over a cumulative period of 2 years.
FAU - Reyes, Magali
AU  - Reyes M
AD  - Johnson & Johnson Pharmaceutical Research and Development, 1125 
      Trenton-Harbourton Road, Titusville, NJ 08530, USA. MHarde@prdus.jnj.com
FAU - Croonenberghs, Jan
AU  - Croonenberghs J
FAU - Augustyns, Ilse
AU  - Augustyns I
FAU - Eerdekens, Marielle
AU  - Eerdekens M
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Antipsychotic Agents)
RN  - L6UH7ZF8HC (Risperidone)
SB  - IM
MH  - Adolescent
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Behavior/drug effects
MH  - Child
MH  - Cognition/drug effects
MH  - Conduct Disorder/*drug therapy
MH  - Female
MH  - Humans
MH  - Intellectual Disability
MH  - Intelligence
MH  - Male
MH  - Risperidone/adverse effects/*therapeutic use
MH  - Treatment Outcome
EDAT- 2006/06/14 09:00
MHDA- 2006/11/09 09:00
CRDT- 2006/06/14 09:00
PHST- 2006/06/14 09:00 [pubmed]
PHST- 2006/11/09 09:00 [medline]
PHST- 2006/06/14 09:00 [entrez]
AID - 10.1089/cap.2006.16.260 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2006 Jun;16(3):260-72. doi: 
      10.1089/cap.2006.16.260.