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

Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri 63117, USA.
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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    • "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.
    Indian Journal of Psychological Medicine 03/2014; 36(1):66-70. DOI:10.4103/0253-7176.127254
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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.
    Neuropsychiatrie de l Enfance et de l Adolescence 01/2012; 60(1). DOI:10.1016/j.neurenf.2011.10.011
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    • "Risperidone was also studied for its control of aggression in children and adolescents with bipolar disorder [34,35] and pervasive developmental disorder [36-39]. Again, risperidone was effective and safe in these trials and demonstrated a good side-effect profile, especially in low doses. "
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    ABSTRACT: The DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th edition Textrevision) highlights the especially poor outcomes of early-onset conduct disorder (CD). The strong link between the patient's age at treatment and its efficacy points the importance of early intervention. Risperidone is one of the most commonly studied medications used to treat CD in children and adolescents. The aim of this study is to obtain preliminary data about the efficacy and tolerability of risperidone treatment in otherwise typically developing preschool children with conduct disorder and severe behavioral problems. We recruited 12 otherwise normally developing preschoolers (ten boys and two girls) with CD for this study. We could not follow up with 4 children at control visits properly; thus, 8 children (six girls, two boys; mean age: 42.4 months) completed the study. We treated the patients with risperidone in an open-label fashion for 8 weeks, starting with a daily dosage of 0.125 mg/day or 0.25 mg/day depending on the patient's weight (<20 kg children: 0.125 mg/day; >20 kg children: 0.25 mg/day). Dosage titration and increments were performed at 2-week interval clinical assessments. The Turgay DSM-IV Based Disruptive Behavior Disorders Child and Adolescent Rating & Screening Scale (T-DSM-IV-S) as well as the Clinical Global Impression Scale (CGI) assessed treatment efficacy; the Extrapyramidal Symptom Rating Scale (ESRS) and laboratory evaluations assessed treatment safety. The mean daily dosage of risperidone at the end of 8 weeks was 0.78 mg/day (SD: 0.39) with a maximum dosage of 1.50 mg/day. Based on the CGI global improvement item, we classified all patients as "responders" (very much or much improved). Risperidone was associated with a 78% reduction in the CGI Severity score. We also detected significant improvements on all of the subscales of the T-DSM-IV-S. Tolerability was good, and serious adverse effects were not observed. We detected statistically significant prolactin level increments (p < 0.05), but no clinical symptoms associated with prolactinemia. The results of this study suggest that risperidone may be an effective and well-tolerated atypical antipsychotic for the treatment of CD in otherwise normally developing preschool children. The findings of the study should be interpreted as preliminary data considering its small sample size and open-label methodology.
    Child and Adolescent Psychiatry and Mental Health 04/2011; 5(1):10. DOI:10.1186/1753-2000-5-10
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