PMID- 24138011
OWN - NLM
STAT- MEDLINE
DCOM- 20140526
LR  - 20220330
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 23
IP  - 8
DP  - 2013 Oct
TI  - Aripiprazole treatment of irritability associated with autistic disorder and the 
      relationship between prior antipsychotic exposure, adverse events, and weight 
      change.
PG  - 572-6
LID - 10.1089/cap.2012.0075 [doi]
AB  - OBJECTIVE: The purpose of this study was to evaluate the impact of prior 
      antipsychotic exposure (PAE) on safety and tolerability outcomes in pediatric 
      subjects receiving aripiprazole treatment. METHODS: This study was a post-hoc 
      analysis of pooled data from two 8-week, double-blind, randomized, 
      placebo-controlled studies evaluating aripiprazole for the treatment of 
      irritability in pediatric subjects with autistic disorder, aged 6-17 years. 
      Subjects were stratified by PAE; adverse events (AEs), and changes in weight, and 
      metabolic measures were evaluated. For subjects receiving aripiprazole, 
      regardless of PAE, baseline weight, age, gender, and symptom severity were 
      evaluated in a regression model predicting body weight change. RESULTS: Of 316 
      randomized subjects, 259 (82.0%) were antipsychotic naive (AN) and 57 (18.0%) had 
      a PAE. Aripiprazole-treated AN subjects were more likely than PAE subjects to 
      report somnolence (11.9% vs. 2.8%), sedation (22.7% vs. 11.1%), or fatigue (17.0% 
      vs. 13.9%). Rates of extrapyramidal disorder and drooling, but not akathisia or 
      tremor, were marginally higher in AN subjects. Overall, 10.8% of 
      aripiprazole-treated AN subjects had at least one AE leading to discontinuation 
      compared with 8.3% of aripiprazole-treated PAE subjects. AN subjects receiving 
      aripiprazole had a larger change in weight from baseline to endpoint compared 
      with those receiving placebo (1.9 vs. 0.7 kg; treatment difference 1.2 kg, 95% 
      CI: 0.5, 1.9) than PAE subjects receiving aripiprazole compared with subjects 
      receiving placebo (0.4 vs. -0.4 kg; treatment difference 0.9 kg, 95% CI: -0.6, 
      2.4). Regression analysis identified that younger subjects with higher baseline 
      weight z-score were at highest risk for weight gain. There were no significant 
      changes in metabolic measures compared with placebo in either group. CONCLUSIONS: 
      Weight gain was more pronounced in AN subjects and more likely to occur in 
      younger subjects with a higher baseline weight z-score. AN subjects were more 
      likely to experience AEs related to somnolence. However, based on 
      discontinuations rates from AEs, overall tolerability was good for both AN and 
      PAE groups. CLINICAL TRIAL REGISTRATION: Study of aripiprazole in the treatment 
      of children and adolescents with autistic disorder. Registry: 
      www.clinicaltrials.gov . Identifiers: NCT00332241 and NCT00337571.
FAU - Mankoski, Raymond
AU  - Mankoski R
AD  - 1 Bristol-Myers Squibb , Plainsboro, NJ.
FAU - Stockton, Gwen
AU  - Stockton G
FAU - Manos, George
AU  - Manos G
FAU - Marler, Sabrina
AU  - Marler S
FAU - McQuade, Robert
AU  - McQuade R
FAU - Forbes, Robert A
AU  - Forbes RA
FAU - Marcus, Ronald
AU  - Marcus R
LA  - eng
SI  - ClinicalTrials.gov/NCT00332241
SI  - ClinicalTrials.gov/NCT00337571
PT  - Journal Article
PT  - Randomized Controlled Trial
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  - 0 (Piperazines)
RN  - 0 (Quinolones)
RN  - 82VFR53I78 (Aripiprazole)
SB  - IM
MH  - Adolescent
MH  - Age Factors
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Aripiprazole
MH  - Autistic Disorder/*drug therapy/*psychology
MH  - Body Weight/*drug effects
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Irritable Mood/*drug effects
MH  - Male
MH  - Piperazines/adverse effects/*therapeutic use
MH  - Quinolones/adverse effects/*therapeutic use
PMC - PMC3804231
EDAT- 2013/10/22 06:00
MHDA- 2014/05/27 06:00
PMCR- 2014/10/01
CRDT- 2013/10/22 06:00
PHST- 2013/10/22 06:00 [entrez]
PHST- 2013/10/22 06:00 [pubmed]
PHST- 2014/05/27 06:00 [medline]
PHST- 2014/10/01 00:00 [pmc-release]
AID - 10.1089/cap.2012.0075 [pii]
AID - 10.1089/cap.2012.0075 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2013 Oct;23(8):572-6. doi: 
      10.1089/cap.2012.0075.