PMID- 19948625
OWN - NLM
STAT- MEDLINE
DCOM- 20091230
LR  - 20220330
IS  - 1098-4275 (Electronic)
IS  - 0031-4005 (Linking)
VI  - 124
IP  - 6
DP  - 2009 Dec
TI  - Aripiprazole in the treatment of irritability in children and adolescents with 
      autistic disorder.
PG  - 1533-40
LID - 10.1542/peds.2008-3782 [doi]
AB  - OBJECTIVE: The objective of this study was to evaluate short-term efficacy and 
      safety of aripiprazole in the treatment of irritability in children and 
      adolescents with autistic disorder who were manifesting behaviors such as 
      tantrums, aggression, self-injurious behavior, or a combination of these. 
      METHODS: This 8-week, double-blind, randomized, placebo-controlled, 
      parallel-group study was conducted of children and adolescents (aged 6-17 years) 
      with autistic disorder. Patients were randomly assigned (1:1) to flexibly dosed 
      aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo. Efficacy outcome 
      measures included the Aberrant Behavior Checklist irritability subscale and the 
      Clinical Global Impression-Improvement score (CGI-I). Safety and tolerability 
      were also assessed. RESULTS: Ninety-eight patients were randomly assigned to 
      receive placebo (n = 51) or aripiprazole (n = 47). Mean improvement in Aberrant 
      Behavior Checklist irritability subscale score was significantly greater with 
      aripiprazole than with placebo from week 1 through week 8. Aripiprazole 
      demonstrated significantly greater global improvements than placebo, as assessed 
      by the mean CGI-I score from week 1 through week 8; however, clinically 
      significant residual symptoms may still persist for some patients. 
      Discontinuation rates as a result of adverse events (AEs) were 10.6% for 
      aripiprazole and 5.9% for placebo. Extrapyramidal symptom-related AE rates were 
      14.9% for aripiprazole and 8.0% for placebo. No serious AEs were reported. Mean 
      weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8. 
      CONCLUSIONS: Aripiprazole was efficacious in children and adolescents with 
      irritability associated with autistic disorder and was generally safe and well 
      tolerated.
FAU - Owen, Randall
AU  - Owen R
AD  - Bristol-Myers Squibb, 5 Research Parkway, Wallingford, Connecticut 06492, USA. 
      randall.owen@bms.com
FAU - Sikich, Linmarie
AU  - Sikich L
FAU - Marcus, Ronald N
AU  - Marcus RN
FAU - Corey-Lisle, Patricia
AU  - Corey-Lisle P
FAU - Manos, George
AU  - Manos G
FAU - McQuade, Robert D
AU  - McQuade RD
FAU - Carson, William H
AU  - Carson WH
FAU - Findling, Robert L
AU  - Findling RL
LA  - eng
SI  - ClinicalTrials.gov/NCT00332241
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatrics
JT  - Pediatrics
JID - 0376422
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Piperazines)
RN  - 0 (Quinolones)
RN  - 82VFR53I78 (Aripiprazole)
SB  - IM
MH  - Adolescent
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Aripiprazole
MH  - Autistic Disorder/diagnosis/*drug therapy/psychology
MH  - Child
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Irritable Mood/*drug effects
MH  - Male
MH  - Personality Assessment
MH  - Piperazines/adverse effects/*therapeutic use
MH  - Quinolones/adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Weight Gain/drug effects
EDAT- 2009/12/02 06:00
MHDA- 2009/12/31 06:00
CRDT- 2009/12/02 06:00
PHST- 2009/12/02 06:00 [entrez]
PHST- 2009/12/02 06:00 [pubmed]
PHST- 2009/12/31 06:00 [medline]
AID - 124/6/1533 [pii]
AID - 10.1542/peds.2008-3782 [doi]
PST - ppublish
SO  - Pediatrics. 2009 Dec;124(6):1533-40. doi: 10.1542/peds.2008-3782.