The side effects ‘ EPS ’ , ‘ parkinsonism ’ , and ‘ tremor ’ were significantly more common in children and adolescents treated with aripiprazole than in those treated with placebo .
Conclusion Our meta- analysis provides evidence for a non-negligible incidence of acute EPS in children and adolescents treated with aripiprazole .
Background Both the US FDA and the European Medicines Agency ( EMA ) have approved aripiprazole for use in adolescents for specific indications .
Given the assumed favorable side-effect profile of aripiprazole , its use in children and adolescents has increased for both official and off-label indications ( anxiety disorders , eating disorders , personality disorders ) .
However , several cases of children and adolescents with new-onset  extrapyramidal symptoms ( EPS )  after commencing treatment with aripiprazole have been reported , and a more systematic appraisal of this possible risk is lacking .
Objective We conducted a systematic review and a meta- analysis to assess the evidence for acute EPS ( acute dystonia , akathisia , Parkinsonism ) associated with the use of aripiprazole in children and adolescents .
Aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder: a pilot randomized clinical trial.
OBJECTIVE To assess response to treatment with aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder ( ADHD ) . METHOD Children and adolescents were extensively assessed according to DSM-IV criteria for bipolar disorder comorbid with ADHD ( n = 710 ) . Those with this comorbidity who were acutely manic or in mixed states were r and omly assigned in a 6-week double-blind , placebo-controlled trial to aripiprazole ( n = 18 ) or placebo ( n = 25 ) . Primary outcome measures were assessed weekly and included the Young Mania Rating Scale ; the Swanson , Nolan , and Pelham Scale-Version IV ; and weight . Secondary outcome measures were the Clinical Global Impressions-Severity of Illness scale , the Child Mania Rating Scale-Parental Version ( CMRS-P ) , the Children 's Depression Rating Scale-Revised , the Kutcher Adolescent Depression Scale , and adverse events . The trial was conducted at the Hospital de Clínicas de Porto Alegre , Rio Gr and e do Sul , Brazil , from January 2005 to November 2007 . RESULTS The group receiving aripiprazole showed a significantly greater reduction in YMRS scores ( P = .02 , effect size [ ES ] = 0.80 ) , CMRS-P scores ( P = .02 ; ES = 0.54 ) , and CGI-S scores ( P = .04 ; ES = 0.28 ) from baseline to endpoint than the placebo group . In addition , higher rates of response ( P = .02 ) and remission ( P = .01 ) were found for the aripiprazole group . No significant between-group differences were found in weight , ADHD symptoms , and depressive symptoms . Adverse events significantly more frequent in the aripiprazole group were somnolence and sialorrhea . CONCLUSION Aripiprazole was effective in reducing manic symptoms and improving global functioning without promoting severe adverse events or weight gain . No significant treatment effect in ADHD symptoms was observed . Studies are needed to assess psychopharmacologic interventions for improving ADHD symptoms in juvenile bipolar disorder comorbid with ADHD . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00116259
The side effects ‘ EPS ’ , ‘ parkinsonism ’ , and ‘ tremor ’ were significantly more common in children and adolescents treated with aripiprazole than in those treated with placebo .
Conclusion Our meta- analysis provides evidence for a non-negligible incidence of acute EPS in children and adolescents treated with aripiprazole .
Background Both the US FDA and the European Medicines Agency ( EMA ) have approved aripiprazole for use in adolescents for specific indications .
Given the assumed favorable side-effect profile of aripiprazole , its use in children and adolescents has increased for both official and off-label indications ( anxiety disorders , eating disorders , personality disorders ) .
However , several cases of children and adolescents with new-onset  extrapyramidal symptoms ( EPS )  after commencing treatment with aripiprazole have been reported , and a more systematic appraisal of this possible risk is lacking .
Objective We conducted a systematic review and a meta- analysis to assess the evidence for acute EPS ( acute dystonia , akathisia , Parkinsonism ) associated with the use of aripiprazole in children and adolescents .