PMID- 16379507
OWN - NLM
STAT- MEDLINE
DCOM- 20060403
LR  - 20161122
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 15
IP  - 6
DP  - 2005 Dec
TI  - Acute and long-term safety and tolerability of risperidone in children with 
      autism.
PG  - 869-84
AB  - Treatment-emergent adverse events (AEs) were monitored during an 8-week, 
      double-blind, placebo-controlled trial of risperidone (0.5-3.5 mg/day) in 101 
      children and adolescents with a lifetime diagnosis of autistic disorder. In 
      addition, 37 placebo nonresponders received open-label risperidone for another 8 
      weeks. Of all the risperidone responders (n=65), 63 entered an open extension of 
      another 16 weeks (6 months total risperidone exposure), and 32 of them were 
      rerandomized to either continued risperidone therapy (n=16) or gradual 
      replacement with placebo (n=16) over 8 weeks. We collected the following measures 
      of safety and tolerability: (1) laboratory blood assessments (CBC with 
      differential, electrolytes, and liver function tests) and urinalyses, (2) vital 
      signs, (3) Side Effects Review of AEs thought to be associated with risperidone, 
      (4) sleep records, (5) Simpson Angus Neurological Rating Scale (SARS), (6) 
      Abnormal Involuntary Movement Scale (AIMS), and (7) height and weight. No 
      clinically significant changes were found on the lab tests. During the 8-week 
      acute trial, the most common AEs on the Side Effects Review, scored as moderate 
      or higher, were as follows (placebo and risperidone, respectively): Somnolence 
      (12% and 37%), enuresis (29% and 33%), excessive appetite (10% and 33%), rhinitis 
      (8% and 16%), difficulty waking (8% and 12%), and constipation (12% and 10%). 
      "Difficulty falling asleep" and anxiety actually favored the risperidone 
      condition at statistically significant levels. The same AEs tended to recur 
      through 6 months of treatment, although often at reduced levels. Using Centers 
      for Disease Control (CDC) standardized scores, both weight and body mass index 
      (BMI) increased with risperidone during the acute trial (0.5 and 0.6 SDs, 
      respectively, for risperidone; 0.0 and 0.1 SDs, respectively, for placebo) and 
      into open-label extension (0.19 and 0.16 SDs, respectively), although the amount 
      of gain decelerated with time. Extrapyramidal symptoms, as assessed by the SARS, 
      were no more common for drug than placebo, although drooling was reported more 
      often in the risperidone group. There were no differences between groups on the 
      AIMS. Two subjects had seizures (one taking placebo), but these were considered 
      unrelated to active drug. Most AEs were mild to moderate and failed to interfere 
      with therapeutic changes; there were no unanticipated AEs. The side effects of 
      most concern were somnolence and weight gain.
FAU - Aman, Michael G
AU  - Aman MG
AD  - The Nisonger Center, Ohio State University, Columbus, Ohio 43210-1296, USA. 
      aman.1@osu.edu
FAU - Arnold, L Eugene
AU  - Arnold LE
FAU - McDougle, Christopher J
AU  - McDougle CJ
FAU - Vitiello, Benedetto
AU  - Vitiello B
FAU - Scahill, Lawrence
AU  - Scahill L
FAU - Davies, Mark
AU  - Davies M
FAU - McCracken, James T
AU  - McCracken JT
FAU - Tierney, Elaine
AU  - Tierney E
FAU - Nash, Patricia L
AU  - Nash PL
FAU - Posey, David J
AU  - Posey DJ
FAU - Chuang, Shirley
AU  - Chuang S
FAU - Martin, Andres
AU  - Martin A
FAU - Shah, Bhavik
AU  - Shah B
FAU - Gonzalez, Nilda M
AU  - Gonzalez NM
FAU - Swiezy, Naomi B
AU  - Swiezy NB
FAU - Ritz, Louise
AU  - Ritz L
FAU - Koenig, Kathleen
AU  - Koenig K
FAU - McGough, James
AU  - McGough J
FAU - Ghuman, Jaswinder K
AU  - Ghuman JK
FAU - Lindsay, Ronald L
AU  - Lindsay RL
LA  - eng
GR  - N01MH70009/MH/NIMH NIH HHS/United States
GR  - M01 RR06022/RR/NCRR NIH HHS/United States
GR  - N01MH80011/MH/NIMH NIH HHS/United States
GR  - N01MH70010/MH/NIMH NIH HHS/United States
GR  - K23 MH001883-02/MH/NIMH NIH HHS/United States
GR  - M01 RR00750/RR/NCRR NIH HHS/United States
GR  - M01RR00052/RR/NCRR NIH HHS/United States
GR  - MH01805/MH/NIMH NIH HHS/United States
GR  - N01MH70001/MH/NIMH NIH HHS/United States
GR  - M01 RR00034/RR/NCRR NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
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  - Adverse Drug Reaction Reporting Systems
MH  - Antipsychotic Agents/administration & dosage/*adverse effects
MH  - Autistic Disorder/diagnosis/*drug therapy/psychology
MH  - Body Mass Index
MH  - Body Weight/drug effects
MH  - Child
MH  - Child, Preschool
MH  - Disorders of Excessive Somnolence/chemically induced
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Long-Term Care
MH  - Male
MH  - Risperidone/administration & dosage/*adverse effects
EDAT- 2005/12/29 09:00
MHDA- 2006/04/04 09:00
CRDT- 2005/12/29 09:00
PHST- 2005/12/29 09:00 [pubmed]
PHST- 2006/04/04 09:00 [medline]
PHST- 2005/12/29 09:00 [entrez]
AID - 10.1089/cap.2005.15.869 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2005 Dec;15(6):869-84. doi: 
      10.1089/cap.2005.15.869.