A Double-Blind Pilot Study of Risperidone in the Treatment of Conduct Disorder
ABSTRACT 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.
- SourceAvailable from: Jacob A S Vorstman
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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. "
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.European neuropsychopharmacology: the journal of the European College of Neuropsychopharmacology 06/2015; DOI:10.1016/j.euroneuro.2015.06.009 · 5.40 Impact Factor
Journal of child and adolescent psychopharmacology 04/2015; 25(3):201-202. DOI:10.1089/cap.2015.2532 · 3.07 Impact Factor
- "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. "
Value in Health 11/2011; 14(7). DOI:10.1016/j.jval.2011.08.1610 · 2.89 Impact Factor
- "The approved drugs include analgesics and sedatives/hypnotics for pain relief, hydroxyzine for situational anxiety, tricyclic antidepressants for nocturnal enuresis (6-year-olds and older), and amphetamines for ADHD  . Controlled trials have also evaluated antipsychotic medications for schizophrenia  and monotherapy using antipsychotics or mood stabilisers for bipolar disorder in younger patients   . The medication efficacy in these trials has not been robust, whereas the side-effect concerns and drop-out rates are considerable  . "