Aripiprazole Monotherapy in Children and Young Adolescents with Pervasive Developmental Disorders

Masi, Gabriele; Cosenza, Angela; Millepiedi, Stefania; Muratori, Filippo; Pari, Cinzia; Salvadori, Francesco

doi:10.2165/00023210-200923060-00005

Cited by 51 publications

(29 citation statements)

References 42 publications

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“…Of the five patients who discontinued aripiprazole due to adverse effects (akathisia and insomnia), three were concomitantly using psychotropics strongly associated with the release of dopamine (risperidone, ziprasidone, methylphenidate) or with the tendency to inhibit cytochrome P450 2D6 and 3A4 enzyme activities (fluoxetine), possibly increasing the susceptibility to adverse events. A long-term naturalistic evaluations of aripiprazole monotherapy in children and adolescents reported that 26-50% of the patients experience adverse events 7-9. Adverse events occurred in 57% (n=8) patients in this study suggesting that augmentation use may have similar rate of adverse event.…”

Section: Discussionmentioning

confidence: 55%

Retrospective Case Series of Aripiprazole Augmentation in Pervasive Developmental Disorders

Kim

Cho

Shin

et al. 2010

Psychiatry Investig

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Due to co-morbidities and treatment resistant nature of pervasive developmental disorder (PDD), diverse combinations of regimens have been tried. This retrospective study aimed to explore adjunctive use of aripiprazole in children with PDD. Changes in illness severity were measured by Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I) in 14 aripiprazole-treated patients with PDD. Improvement of illness severity was observed after aripiprazole add-on (5.8±0.8 to 4.9±1.0, Z=-2.75, p=0.001). Mean dosage was 7.7 mg/day [standard deviation (SD) 3.3, range 5-15]. A higher mean dosage was observed in group with improvement in symptoms (t=-2.33, df =12, p=0.004). The target symptoms most effectively improved after using aripiprazole were positive psychotic symptoms (mean CGI-I: 2.0±1.4, 3 responders/4 patients, 75% response) followed by aggressive behavior (2.5±1.7, 3/4, 75%), self-injurious behavior (2.0±1.0, 2/3, 67%), stereotypic behavior (2.7±1.2, 2/3, 67%), tic (2.8±1.0, 2/4, 50%), irritability (3.5±2.1, 1/2, 50%), obsessive behavior (2.5±2.1, 1/3, 33%), hyperactivity (3.4±1.6, 3/7, 43%) and mood fluctuation (3, 0/1, no response). Five patients (35%) discontinued aripiprazole due to treatment-emergent adverse effects (akathisia, insomnia, withdrawal). The results of this study suggest that aripiprazole augmentation may be used safely in maladaptive behaviors of some populations of PDD. However, future studies are required to confirm these preliminary findings.

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Section: Discussionmentioning

confidence: 55%

Retrospective Case Series of Aripiprazole Augmentation in Pervasive Developmental Disorders

Kim

Cho

Shin

et al. 2010

Psychiatry Investig

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“…Of the 41 studies included, 37 [24–31, 33–37, 43, 45, 46, 48–59, 62, 65–68, 73–76] described the mean age of the participants. The weighted average age was 11.7 years, with a few outliers: Findling and colleagues [26, 33] focused on participants aged 4–9 years, Bildik et al [34] focused on adolescents aged 15–19 years, and the mean age in the study by Woods et al [35] was 17.1 years.…”

Section: Resultsmentioning

confidence: 99%

“…The mean incidence of dystonia, parkinsonism, tremor, and tardive dyskinesia could only be analysed in a smaller group of patients because available data were limited. The mean incidence of tardive dyskinesia was 1.7 % (95 % CI 0.010–0.028; N = 15, n = 1261) [24–27, 30, 33, 34, 46, 55, 56, 58, 65, 67, 68, 73], the mean incidence of tremor was 10.5 % (95 % CI 0.065–0.165; N = 17, n = 1055) [24, 28–30, 34, 48, 50, 55–59, 62, 65, 66, 68, 76], the mean incidence of dystonia was 4.8 % (95 % CI 0.026–0.087; N = 11, n = 785) [24, 25, 27, 29, 31, 34, 46, 48, 55, 64, 68], and the mean incidence of parkinsonism was 20.8 % (95 % CI 0.159–0.269; N = 10, n = 755) [24, 25, 27, 45, 46, 52, 55, 56, 68, 73]. …”

Section: Resultsmentioning

confidence: 99%

Aripiprazole and Acute Extrapyramidal Symptoms in Children and Adolescents: A Meta-Analysis

et al. 2016

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BackgroundBoth 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.ObjectiveWe 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.MethodWe searched the MEDLINE and Embase databases (2003–10 April 2016) for clinical trials in pediatric patients (aged 0–18 years) using the keywords ‘aripiprazole’ (regardless of the formulation) and ‘extrapyramidal symptoms’. We evaluated the abstracts of papers using the following exclusion criteria: (1) study design: case report, letter to the editor, editorial, or poster presentation data; (2) unrelated PICOS (population, intervention, comparators, outcomes, study) structure. We performed a meta-analysis, in which we used effect sizes with 95 % confidence intervals (CIs). To examine the homogeneity of the effect size distribution, we used a Q-statistic. When we observed heterogeneity in effect sizes, we assessed the possible influence of moderator variables (age and sex, mean dose, study duration, and method of measuring EPS incidence) and evaluated the suitability of either a fixed or a random model. Finally, we assessed the incidence of EPS in children and adolescents treated with aripiprazole compared with placebo.ResultsAn initial search via PubMed and Embase yielded 328 hits. A manual search of the reference lists of review papers revealed seven additional relevant articles. We included 41 studies, with 2114 pediatric patients, in the meta-analysis. For the analysis of the mean incidence of EPS, data were provided by 24 studies, with a total of 1446 pediatric patients. Meta-analysis revealed a mean EPS incidence of 17.1 % (95 % CI 0.128–0.223). In terms of the incidence of various extrapyramidal side effects, overall, no significant effects of age, sex, mean dose, study duration, or measuring method could be demonstrated. The side effects ‘EPS’, ‘parkinsonism’, and ‘tremor’ were significantly more common in children and adolescents treated with aripiprazole than in those treated with placebo.ConclusionOur meta-analysis provides evidence for a non-negligible incidence of acute EPS in children and adolescents treated with aripiprazole. Although the study has several limitations and further investigation is needed, these findings may help clinicians make more balanced treatment choices and more closely monitor the use of this drug in youth.Electronic supplementary materialThe online version of this article (doi:10.1007/s40...

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“…As many as 11 of the patients (32.4%) were judged to be ‘much improved’ or ‘very much improved’ by the CGI-I. A total of 12 of the subjects (35.3%) were determined to be ‘minimally improved’ and 12 of the children (35.3%) stopped the medication owing to side effects or lack of efficacy [18]. …”

Section: Clinical Trialsmentioning

confidence: 99%

Aripiprazole for Irritability Associated with Autistic Disorder in Children and Adolescents Aged 6–17 Years

et al. 2010

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Aripiprazole was recently US FDA-approved to treat irritability in children and adolescents with autistic disorder aged 6–17 years. There are currently only two psychotropics approved by the FDA to treat irritability in the autistic population. This drug profile will discuss available studies of aripiprazole in individuals with pervasive developmental disorders, two of which led to its recent FDA approval. We will discuss the efficacy, as well as the safety and tolerability of the drug documented in these studies. In addition, the chemistry, pharmacokinetics, metabolism and mechanism of action of aripiprazole will be reviewed.

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Aripiprazole Monotherapy in Children and Young Adolescents with Pervasive Developmental Disorders

Cited by 51 publications

References 42 publications

Retrospective Case Series of Aripiprazole Augmentation in Pervasive Developmental Disorders

Retrospective Case Series of Aripiprazole Augmentation in Pervasive Developmental Disorders

Aripiprazole and Acute Extrapyramidal Symptoms in Children and Adolescents: A Meta-Analysis

Aripiprazole for Irritability Associated with Autistic Disorder in Children and Adolescents Aged 6–17 Years

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