Risperidone in Preschool Children with Autistic Spectrum Disorders: An Investigation of Safety and Efficacy

Harvard University, Cambridge, Massachusetts, United States
Journal of Child and Adolescent Psychopharmacology (Impact Factor: 2.93). 11/2006; 16(5):575-87. DOI: 10.1089/cap.2006.16.575
Source: PubMed


Early intervention in autism spectrum disorders (ASDs) appears promising and may represent a window of opportunity for more effective treatment. Whereas the safety and efficacy of risperidone have been established for children aged 5 and older, they has not been adequately tested in preschool children.
A randomized placebo-controlled study of risperidone in preschool children was conducted in a sample of young children, most of whom were also undergoing intensive behavioral treatment.
Preschool children tolerated low-dose risperidone well with no serious adverse effects observed over a 6-month treatment period. Weight gain and hypersalivation were the most common side effects reported, and hyperprolactinemia without lactation or related signs was observed. Significant differences between groups found at baseline complicated the analyses; however, controlling for some of these differences revealed that preschoolers on risperidone demonstrated greater improvements in autism severity. The change in autism severity scores from baseline to 6-month follow up for the risperidone group was 8% compared to 3% for the placebo group. Notably, both groups significantly improved over the 6-month treatment period.
Study findings suggest that risperidone is well tolerated in preschoolers over a 6-month period, but that only minimally greater improvement in target symptoms was evident in the risperidone group, possibly due to the differences between groups at baseline or due to the small sample size. Although these findings are not sufficient to direct treatment, they suggest that larger-scale, double-blind, placebo-controlled investigations of risperidone in preschoolers with ASDs should now be conducted.

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    • "As far as its tolerability is concerned most studies report weight gain, sedation and hyperprolactinemia as adverse effects. To date, Risperidone is often regarded as the " first-line " medication in ASD (McCracken et al., 2002;Shea et al., 2004;Troost et al., 2005;Malone, 2006;Aman et al., 2009;Luby et al., 2006;Nagaraj et al., 2006;Anderson et al., 2007;Martin et al., 2004). In a recent randomised, double-blind, placebo-controlled trial, Memantine was used as adjunctive treatment to Risperidone in children with autistic disorder. "
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    ABSTRACT: Purpose – The management of individuals with autism spectrum disorders (ASDs) requires a multimodal approach of behavioural, educational and pharmacological treatments. At present, there are no available drugs to treat the core symptoms of ASDs and therefore a wide range of psychotropic medications are used in the management of problems behaviours, co-occurring psychiatric disorders and other associated features. The purpose of this paper is to map the literature on pharmacological treatment in persons with ASD in order to identify those most commonly used, choice criteria, and safety. Design/methodology/approach – A systematic mapping of the recent literature was undertaken on the basis of the following questions: What are the most frequently used psychoactive compounds in ASD? What are the criteria guiding the choice of a specific compound? How effective and safe is every psychoactive drug used in ASD? The literature search was conducted through search engines available on Medline, Medmatrix, NHS Evidence, Web of Science and the Cochrane Library. Findings – Many psychotropic medications have been studied in ASDs, but few have strong evidence to support their use. Most commonly prescribed medications, in order of frequency, are antipsychotics, antidepressants, anticonvulsants and stimulants, many of them without definitive studies guiding their usage. Recent animal studies can be useful models for understanding the common pathogenic pathways leading to ASDs, and have the potential to offer new biologically focused treatment options. Originality/value – This is a practice review paper applying recent evidence from the literature.
    No preview · Article · Jan 2016
    • "This scale has been validated and is a reliable scale that assesses severity of the autistic symptoms and, therefore, is used to detect the degree of improvement.[8111213] However, it should be noted that changes in the subscales of CARS in addition to its total score after drug therapy have been analyzed in only a limited number of studies.[8910141516] Risperidone has been used in the treatment of many children and adolescents with autism; however, its effectiveness on the core symptoms of autism has not been widely studied. "
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    ABSTRACT: The aim of the present study was to evaluate the effect of risperidone in patients afflicted by autistic disorder especially with regards to its three core symptoms, including "relating to others", "communication skills", and "stereotyped behaviors" based on Childhood Autism Rating Scale (CARS). An 8-week open-label study of risperidone for treatment of autistic disorder in children 4-17 years old was designed. Risperidone dose titration was as follow: 0.02 mg/kg/day at the first week, 0.04 mg/kg/day at the second week, and 0.06 mg/kg/day at the third week and thereafter. The outcome measures were scores obtained by CARS, Aberrant Behavior Checklist (ABC), and Clinical Global Impression-Improvement (CGI-I) scale. Fifteen patients completed this study. After 8 weeks, CARS total score decreased significantly, (P=0.001). At the end of the study, social interactions and verbal communication skills of the patients were significantly improved (P<0.001, P=0.03, respectively). However, stereotypic behaviors did not show any significant change in this study. Increase in appetite and somnolence were the most reported side effects. This study suggests that risperidone may be an effective treatment for the management of core symptoms of autistic disorder.
    No preview · Article · Mar 2014 · Indian Journal of Psychological Medicine
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    • "Divalproex sodium (834 mg/j vs placebo 7 vs 6 9 ans [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] 8 semaines CY-BOCS Divalproex > placebo (p = 0,037) Bonne tolérance. Hellings et al., 2005 [30] Valproate (75,5 mcg/mL) vs placebo 16 vs 14 12,1 ans [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] 8 semaines CGI ABC-i OAS Pas de différence significative Effets secondaires : augmentation de l'appétit, rash cutané Wasserman et al., 2006 [32] Levetiracétam 10 vs 10 5 à 17 ans 10 semaines CGI ABC CY-BOCS Levetiracétam = placebo Belsito et al., 2001 [31] Lamotrigine (5 mg/kg) vs placebo 14 vs 14 5,8 ans [3–11] 18 semaines ABC et autres echelles (CARS, ADOS-PL, VABS) Lamotrigine = placebo CGI : clinical global impression ; CY-BOCS : Children Yale-Brown Obsessive-Compulsive Scale ; ABC : aberrant behaviour checklist. "
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    ABSTRACT: Global Management of autistic people primarily requires behavioral and educational therapy. There is actually no psychopharmacological agent that is efficient on the core symptoms of autism, especially the social and communicative impairments.However psychotropic medications are widely prescribed in this population and as mush as 1 out 2 people with autism receives at least one medication. In this population, medications are mainly directed at the frequently associated behavioral symptoms such as aggression toward self or others, tantrums, hyperactivity, severe repetitive behaviors. The goal of this article is to provide a review of the existing controlled studies in this area. The presented studies aim the following therapeutic classes: atypical antipsychotics, selective serotonin reuptake inhibitors (SSRI), psychostimulants and antiepileptics. The studies and there mains results in terms of efficiency and safety are presented in tables. Atypical antipsychotics, especially risperidone and aripiprazole have been shown to be useful in the treatment of behavioral symptoms. SSRI seem to have limited interest for the management of repetitive behaviors. Stimulants can help in case of hyperactivity and attention deficit associated with Autism spectrum disorders. Antiepileptics show promising results, but the best indications for this class are not clear. For sleep disturbances, melatonin can be a safe and efficient option.Challenging behaviors requires careful investigation to understand their origin in order to provide the specific management. The first answer should be environmental and educational .Somatic or mental diseases should be carefully assessed.Medication use in this vulnerable population should carefully evaluate the benefit/risk balance. Medications should be prescribed at the minimum dose for the minimum duration.
    Full-text · Article · Jan 2012 · Neuropsychiatrie de l Enfance et de l Adolescence
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