A Double-Blind Pilot Study of Risperidone in the Treatment of Conduct Disorder

Case Western Reserve University, Cleveland, Ohio, United States
Journal of the American Academy of Child & Adolescent Psychiatry (Impact Factor: 7.26). 05/2000; 39(4):509-16. DOI: 10.1097/00004583-200004000-00021
Source: PubMed


To examine whether risperidone is superior to placebo in the treatment of youths with conduct disorder.
This was a 10-week, randomized, double-blind, placebo-controlled study with 2 parallel arms. Ten youths were randomly assigned to receive placebo and 10 youths were randomly assigned to receive risperidone. Patients were seen weekly throughout the trial. Medications could be increased at weekly intervals during the first 6 weeks of the study from an initial dose of 0.25 mg or 0.50 mg each morning, depending on patient weight. Patients weighing less than 50 kg had a maximum total daily dose of risperidone of 1.5 mg. Patients weighing 50 kg or greater had a maximum total daily dose of risperidone of 3.0 mg. The primary outcome measure was the Rating of Aggression Against People and/or Property Scale.
Risperidone was superior to placebo in ameliorating aggression on most measures. Risperidone was reasonably well tolerated, with none of the risperidone-treated patients developing extrapyramidal side effects.
These data provide preliminary evidence that risperidone may have efficacy in the treatment of youths with conduct disorder. Because of the small sample size and the brief length of this study, further research is necessary to confirm these findings.

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    • "Both in the USA and in Europe, prescription rates of SGAs to patients younger than 18 years of age are significantly higher than the prevalence of psychotic disorders (Rani et al., 2008; Kalverdijk et al., 2008; Zito et al., 2013). In fact, these medications are being prescribed for aggression, irritability, negativistic and hostile behaviour in various conditions, such as autism spectrum disorder, oppositional defiant disorder and conduct disorder (Olfson et al., 2012), when evidence of efficacy in " pure " conduct disorder (i.e., without co-morbid intellectual disability) is limited (Findling et al., 2000). Furthermore , many psychiatric disorders in youth persist across development (Costello et al., 2011), requiring long-term drug treatment. "
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    ABSTRACT: Paediatric psychopharmacology holds great promise in two equally important areas of enormous biomedical and social impact, namely the treatment of behavioural abnormalities in children and adolescents, and the prevention of psychiatric disorders with adolescent- or adult-onset. Yet, in striking contrast, pharmacological treatment options presently available in child and adolescent psychiatry are dramatically limited. The most important currently unmet needs in paediatric psychopharmacology are: the frequent off-label prescription of medications to children and adolescents based exclusively on data from randomized controlled studies involving adult patients; the frequent lack of age-specific dose, long-term efficacy and tolerability/safety data; the lack of effective medications for many paediatric psychiatric disorders, most critically autism spectrum disorder; the scarcity and limitations of randomized placebo-controlled trials in paediatric psychopharmacology; the unexplored potential for the prevention of psychiatric disorders with adolescent- and adult-onset; the current lack of biomarkers to predict treatment response and severe adverse effects; the need for better preclinical data to foster the successful development of novel drug therapies; and the effective dissemination of evidence-based treatments to the general public, to better inform patients and families of the benefits and risks of pharmacological interventions during development. Priorities and strategies are proposed to overcome some of these limitations, including the European Child and Adolescent Clinical Psychopharmacology Network, as an overarching Pan-European infrastructure aimed at reliably carrying out much needed psychopharmacological trials in children and adolescents, in order to fill the identified gaps and improve overall outcomes. Copyright © 2015 Elsevier B.V. All rights reserved.
    Full-text · Article · Jun 2015 · European neuropsychopharmacology: the journal of the European College of Neuropsychopharmacology
    • "The Treatment of Severe Childhood Aggression or TOSCA study was a departure from earlier monotherapy studies of medication treatment for aggression because it entailed an attempt to ''normalize'' behavioral outcomes through the use of combined treatment, if needed. The impetus for TOSCA was a series of risperidone studies conducted by Janssen Pharmaceutica and others (e.g., Findling et al., 2000) published in the early 2000s. When designing TOSCA, we were especially interested in risperidone's potential to dampen aggression and other disruptive behaviors. "

    No preview · Article · Apr 2015 · Journal of child and adolescent psychopharmacology
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    • "Six studies were randomized, double-blind, placebo-controlled (Table 1).[353637383940] However, one of them reported the effect of conduct problems rather than CD in children with autistic and other pervasive developmental disorders,[37] one study reported re-analysis of two previous studies,[36] one study reported the effects of maintenance versus withdrawal of risperidone treatment,[35] two studies included children with sub-average intelligence.[3839] "
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    ABSTRACT: This study evaluates the evidence-based administration of risperidone and paliperidone for the treating children and adolescents with conduct disorder (CD). A review of the current literature from clinical trials that investigated the efficacy of risperidone and paliperidone on CD considering the inclusion criteria and search strategies was performed by a search of PubMed and Google Scholar databases. Out of 53 titles, 31 were irrelevant. The abstract of 22 potentially related articles were studied. Only six articles reported the results of clinical trial. However, one of them reported the effect of risperidone on conduct behaviors in autistic disorders. One study was a re-analysis of two previous studies, one study reported the effects of maintenance versus withdrawal of risperidone treatment and two studies included children with sub-average intelligence. Headache, somnolence and increased appetite are among the most common reported adverse effects. No study examined the effect of paliperidone on CD was found. Current literature suggests that risperidone could be effective for treating some conduct behaviors in children and adolescents. The effect of risperidone on CD is not a well-researched area. There is no well-controlled evidence based reports about the safety and efficacy of risperidone for the treatment of CD. Further trials should examine the efficacy of these medications on CD rather than conduct behaviors or disruptive behavior disorders.
    Full-text · Article · Nov 2013 · Journal of research in medical sciences
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