A Randomized Controlled Trial Investigating the Safety and Efficacy of Aripiprazole in the Long-Term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder

Findling, Robert L.; Mankoski, Raymond; Timko, Karen; Lears, Katherine; McCartney, Theresa; McQuade, Robert D.; Eudicone, James M.; Amatniek, Joan; Marcus, Ronald N.; Sheehan, John J.

doi:10.4088/jcp.13m08500

Cited by 91 publications

(80 citation statements)

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“…With regard to EPS, risperidone and aripiprazole showed NNHs of 7 and 20, respectively, in short-term (≤8 weeks) studies, with similar results in long-term studies. 42,53 These NNHs are lower than those reported in RCTs in children with bipolar disorder, which could indicate more sensitivity to EPSs in children with ASD. Additionally, with regard to sedation, risperidone and aripiprazole yielded NNHs of 2 and 16, respectively, in short-term studies, with similar rates in long-term studies.…”

Section: Quality Of Evidencementioning

confidence: 75%

“…51 Relapse rates after the discontinuation phase (without allowing all participants to return to baseline) in the placebo groups (62.5% 51 and 66.7% 52 ) were significantly higher than in the risperidone groups (12.5% 51 and 25.0% 52 ). Long-term efficacy and safety of aripiprazole in the treatment of IA of youth with ASD were assessed in a recent study 53 (Supplemental Table 4), which included a single-blind phase of flexibly dosed (2-15 mg/day) aripiprazole for 13 to 26 weeks, followed by a randomized placebocontrolled withdrawal phase. The primary endpoint was time from randomization to relapse, which was found to be the same between aripiprazole and placebo.…”

Section: Effi Cacymentioning

confidence: 99%

“…Additionally, with regard to sedation, risperidone and aripiprazole yielded NNHs of 2 and 16, respectively, in short-term studies, with similar rates in long-term studies. 42,53,54 Based on effect size calculations for weight gain, aripiprazole results in larger burden on weight than risperidone (3.1 vs 0.9) in short-term studies. However, this finding was complicated by the lower (twofold) mean weight gain in the placebo groups of the aripiprazole studies compared with the risperidone studies and by the fact that the absolute excess over placebo in mean weight gain was greater for risperidone (1.6 kg) than for aripiprazole (1.1 kg).…”

Section: Quality Of Evidencementioning

confidence: 99%

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Pharmacologic Treatment of Severe Irritability and Problem Behaviors in Autism: A Systematic Review and Meta-analysis

et al. 2016

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BACKGROUND: Autism spectrum disorder (ASD) is increasingly recognized as a public health issue. Irritability and aggression (IA) often negatively affect the lives of people with ASD and their families. Although many medications have been tested for IA in ASDs in randomized controlled trials (RCTs), critical quantitative analyses of these trials are lacking in the literature. OBJECTIVES:To systematically review and quantitatively analyze the efficacy and safety of pharmacologic treatments for IA in youth with ASD.DATA SOURCES: Studies were identified from Medline, PsycINFO, Embase, and review articles. METHODS:Original articles on placebo-controlled RCTs of pharmacologic treatments of IA in youth age 2 to 17 years with ASD were included. Data items included study design, study goals, details of study participants, details of intervention, study results, statistical methods, side effects, and risks of bias. The primary study outcome measure was the effect size of reduction in the Aberrant Behavioral Checklist-Irritability (ABC-I) scores in the medication group, as compared with placebo, in RCTs using parallel groups design. RESULTS:Forty-six RCTs were identified. Compared with placebo, 3 compounds resulted in significant improvement in ABC-I at the end of treatment. Risperidone and aripiprazole were found to be the most effective, with the largest effect sizes. Sedation, extrapyramidal sides effects, and weight gain were assessed quantitatively. CONCLUSIONS:Although risperidone and aripiprazole have the strongest evidence in reducing ABC-I in youth with ASD, a few other compounds also showed significant efficacy with fewer potential side effects and adverse reactions in single studies.

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Section: Quality Of Evidencementioning

confidence: 75%

Section: Effi Cacymentioning

confidence: 99%

Section: Quality Of Evidencementioning

confidence: 99%

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Pharmacologic Treatment of Severe Irritability and Problem Behaviors in Autism: A Systematic Review and Meta-analysis

et al. 2016

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“…On the other hand, in a long-term, placebo-controlled trial conducted with autistic children by Findling et al52 aripiorazole patients gained an average of 1.6 kg of weight gain, which was more than the weight gained by placebo recipients. Therefore, careful monitoring of weight should be performed over the course of treatment with aripiprazole, although aripiprazole causes less weight gain in comparison with other atypical antipsychotics.…”

Section: Resultsmentioning

confidence: 90%

Efficacy and Tolerability of Pharmacotherapy Options for the Treatment of Irritability in Autistic Children

Kirino

2014

Clin Med Insights Pediatr

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Children with autism have a high rate of irritability and aggressive symptoms. Irritability or self-injurious behavior can result in significant harm to those affected, as well as to marked distress for their families. This paper provides a literature review regarding the efficacy and tolerability of pharmacotherapy for the treatment of irritability in autistic children. Although antipsychotics have not yet been approved for the treatment of autistic children by many countries, they are often used to reduce symptoms of behavioral problems, including irritability, aggression, hyperactivity, and panic. However, among antipsychotics, the Food and Drug Administration has approved only risperidone and aripiprazole to treat irritability in autism. Among atypical antipsychotics, olanzapine and quetiapine are limited in their use for autism spectrum disorders in children because of high incidences of weight gain and sedation. In comparison, aripiprazole and ziprasidone cause less weight gain and sedation. However, potential QTc interval prolongation with ziprasidone has been reported. Contrary to ziprasidone, no changes were evident in the QT interval in any of the trials for aripiprazole. However, head-to-head comparison studies are needed to support that aripiprazole may be a promising drug that can be used to treat irritability in autistic children. On the other hand, risperidone has the greatest amount of evidence supporting it, including randomized controlled trials; thus, its efficacy and tolerability has been established in comparison with other agents. Further studies with risperidone as a control drug are needed.

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“…Risperidone and aripiprazole have shown positive effects in several different clinical trials especially for ASD-related irritability [27,28]. However, the major drawback of atypical antipsychotics are side effects such as weight gain, metabolic changes, sleep disturbances, higher risk of sedation and tremor, drooling, increased appetite, fatigue, dizziness, and withdrawal dyskinesias [29,30]. Another atypical antipsychotic drug, clozapine, has been shown to be effective against hyperactivity and aggression in children with ASD [31].Therefore, based on limited evidence with small sample sizes and short follow-ups, atypical antipsychotics may be more effective as short-term interventions for certain behavioral symptoms in patients with ASD.…”

Section: Antipsychoticsmentioning

confidence: 99%

Pharmacobiological Treatments in Autism Spectrum Disorders

Jayaraman¹,

Mundkur²

2017

IJCRR

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Autism spectrum disorders (ASD) refer to a group of neuro-developmental disorders affecting young children and adults. Currently, the treatment options for ASD are mostly restricted to treating its symptoms. Among the various approaches for treating ASD, pharmacobiology-based treatments are numerous. Our objective is to review the up-to-date information on different types of medications and briefly discuss the evidence-based potential of these treatments in ASD therapy. PubMed searches for reports and reviews on clinical data from the last 15 years, between 2002-2017, using search terms of each category of treatment along with the terms "autism", "mechanism", and/or "side effects" were conducted. Several pharmacobiological interventions have been prescribed for ASD, including antipsychotics, stimulants, antidepressants, supplements, and special diets. However, none of these methods is an effective ASD treatment, and only few show much promise. We provide a brief overview of the current pharmacobiological treatments for ASD, their mechanisms of action, and clinical research-based evidence on their effectiveness. Based on our review, we recommend that caution should be exercised when choosing a pharmacobiological treatment method for ASD as majority of existing evidence is not from large-scale long-term high quality studies.Future research should focus on rigorous investigative design, long-term implementation, and meaningful uniform outcome measurements.

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A Randomized Controlled Trial Investigating the Safety and Efficacy of Aripiprazole in the Long-Term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder

Abstract: ClinicalTrials.gov identifier: NCT01227668.

Cited by 91 publications

References 0 publications

Pharmacologic Treatment of Severe Irritability and Problem Behaviors in Autism: A Systematic Review and Meta-analysis

Pharmacologic Treatment of Severe Irritability and Problem Behaviors in Autism: A Systematic Review and Meta-analysis

Efficacy and Tolerability of Pharmacotherapy Options for the Treatment of Irritability in Autistic Children

Pharmacobiological Treatments in Autism Spectrum Disorders

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