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Risperidone is one of the most commonly used atypical antipsychotic drugs in the treatment of children and adolescents. However, the data about its use in children and adolescents with conduct disorder CD are limited.
The aim of this study was to investigate the effectiveness and tolerability of risperidone in controlling major symptoms of CD in children and adolescents diagnosed with attention deficit hyperactivity disorder ADHDoppositional defiant disorder ODDand severe CD. The patients were treated with risperidone in an open-label fashion for vafan weeks, starting at a daily dosage of 0. The study population comprised 21 children and adolescents 17 boys, 4 girls with a mean SD age of The mean SD dosage of risperidone at the end of 8 weeks of treatment was 1.
No severe adverse events were reported. The results of this study are consistent with previous findings and suggest that risperidone may be an effective and well-tolerated atypical antipsychotic drug for the treatment of children and adolescents with CD. However, further studies, particularly placebo-controlled and double-blinded, are needed to better define the clinical use of risperidone in children and adolescents with CD. Conduct disorder CD is one of the most common psychiatric disorders in childhood and adolescence.
These symptoms are often accompanied by hyperactivity, impulsive behavior, explosiveness, cognitive and learning problems, and poor social skills. Appropriate early intervention may be anotherpredictive factor of outcome for children with CD.
Antipsychotic drugs are prescribed for as many as half of pediatric psychiatric inpatients and one third of pediatric psychiatric outpatients. Aggression, not psychosis, is the symptom for which antipsychotic drugs are most often prescribed. Risperidone is one of the most commonly used atypical antipsychotic drugs used in the treatment of children and adolescents. It has properties of potent 5-hydroxytryptamine 2 and dopamine 2 receptor antagonists.
The aim of this single-center, open-label study was to examine the effectiveness and tolerability of risperidone in controlling major symptoms of CD in children and adolescents diagnosed with attention deficit hyperactivity disorder ADHDoppositional defiant disorder ODDand azmo CD.
Furthermore, patients were included only if they had been found to be refractory to methylphenidate therapy prior to this study. The Clinical Global Impression CGI scale 17 is a clinician-rated scale that is used to assess severity of illness and global improvement, both of which are rated on a scale of 1 to 7. Lower scores reflect reduced psychopathology faran greater therapeutic effectiveness. Recruitment and screening procedures were designed to collect a carefully diagnosed sample of children and adolescents with severe CD.
Children were first interviewed by the senior author E. The children who were diagnosed with CD in the same way by szmi investigators were included in the study. The parents and the children were informed about the study, and written informed consent was obtained from one of the parents and assent from the children prior to varsn titration phase.
Risperidone in Children and Adolescents with Conduct Disorder: A Single-Center, Open-Label Study
Patients were included in the study if they met the following inclusion criteria: The medication was individually regulated, with incremental increases up to 0. Patients visited the unit once a week vagan the first 4 weeks, and the final assessment was performed at the end of week 8.
No other psychotropic drugs were administered during the trial. To assess the effectiveness of the drug treatment, parent and teacher forms of the T- DSM-IV scale and severity of illness and global improvement subscales of the CGI scale were used. CGI severity of illness subscale ratings were completed at baseline and at the end of weeks 4 and 8, whereas CGI global improvement subscale ratings were completed at the end of weeks 4 and 8. Axmi patients underwent a complete review of current health status, which included a careful medical history.
Complete blood cell counts, liver function tests, and electrocardiograms were performed at baseline and at the end of the study. The Extrapyramidal Symptom Rating Scale 20 ESRS was used in the assessment of extrapyramidal adverse events at baseline and at the end of weeks 4 and 8. Patients found to have extrapyramidal symptoms were to be treated with benztropine. Body weight gain and sleep duration also were assessed at baseline and at the end of weeks 4 and 8. Data are reported as mean SD. Data were analyzed with the Statistical Package for the Social Sciences version Paired-sample t -test and Pearson product moment correlation were used in the analyses of numeric variables.
Twenty-one patients were screened for the study. Twenty-one children and adolescents 17 boys and 4 girls with a mean SD age of All 21 patients were classified as having severe CD: Vafan mean SD full-scale IQ for the group was Twenty varaan the 21 patients completed the 8-week study period. The only patient who withdrew from the study did so at the end of week 4 because his parents believed that he was not benefiting from the drug treatment. The mean SD dosage of risperidone at the end of week 8 was 1.
A common adverse event was body weight gain; patients gained a mean SD of 1. No clinical evidence of extrapyramidal symptoms was detected with the ESRS. Therefore, no patient required treatment with benztropine. Although all patients exhibited mild sedation in the beginning of the study, this adverse event was transitory. Sleep duration was monitored by parental observation, with a mean sleep increase of 0.
No treatment-related clinically significant changes in complete blood cell count, liver function tests, or electrocardiography were found.
In general, risperidone was well tolerated. Also, a significant improvement was found in the ratings of severity of illness after 8 weeks of treatment on the CGI severity of illness subscale. Consistent with our findings, in a double-blind, placebo-controlled study of 20 children and adolescents with CD, Findling et al 5 reported that risperidone was superior to placebo in ameliorating aggression on most measures. Turgay et al 8 conducted a double-blind, placebo-controlled study of children with severe CD and mental retardation.
After a 6-week trial of risperidone versus placebo, they found that risperidone was significantly more effective than placebo in reducing Nisonger Child Behavior Rating Form 5 conduct problem subscale scores.
Reports from studies of risperidone in autistic children and adolescents also have shown that risperidone is a beneficial agent in treating conduct problems.
The higher rate of improvement found in this study could partly be explained by the severity of the CD in our patients. Because only severe cases of CD were included in the study, our patients’ scores could improve more. Significant improvement in the symptoms of CD observed in this study are consistent with thefindings of Findling et al.
Because a well-known side effect of atypical antipsychotic drugs is sedation, we did not anticipate improvement in inattention. Similarly unexpected improvements, such as improvement on the Psychosomatic T score of Conners Parent Rating Scale in the study by Findling et al, 5 have been previously reported.
The investigators suggested that unexpected improvement resulted from a better overall sense of well-being in those children.
Nicolson et al 7 reported that autistic children who responded to risperidone treatment were better able to focus on their work at school. This result is also consistent with our findings of the improvement in inattention.
However, the beneficial effects of risperidone on inattention must be regarded as a tentative hypothesis until additional controlled studies have shown that risperidone is effective in improving inattention in children and adolescents with CD. The mean final dosage of risperidone 1.
As Findling et al 5 stated, low doses of risperidone seem to be effective in treating children and adolescents with CD. Risperidone was well tolerated in our study, and no patient was discontinued from the study because of adverse events. Similar to the findings of previous studies 5,7,8 in which risperidone was used in low doses, the only important adverse event in our study was body weight gain. In 2 reviews 6,12 of pharmacotherapy studies in children and adolescents with pervasive developmental disorders, the investigators suggested that low doses of risperidone may cause body weight gain.
The mean SD body weight gain of 1. The lower levels of body weight gain in our study may have been the result of investigators warning parents about this side effect. No evidence of marked sedation, extrapyramidal symptoms, abnormalities in liver function, or significant changes on electrocardiography or complete blood count was found in our study.
As explained by Findling et al, 21 initiating risperidone treatment at low doses and titrating the drug gradually can significantly reduce the risk for extrapyramidal symptoms.
Results of previous short-term studies 6,12 with low-dose risperidone also suggested that risperidone is well tolerated in children and adolescents, which is consistent with vwran findings. The results of our study should be interpreted cautiously because of several limitations.
Most importantly, this was an open-label trial without a placebo-control group. Other important limitations of the study were its small sample size and short duration. Further studies, particularly with a double-blind, placebo-controlled design and larger samples, are needed to better define the clinical use of risperidone in children and adolescents with CD.
National Center for Biotechnology InformationU. Curr Ther Res Clin Exp. Author information Copyright and License information Disclaimer. Published by Elsevier Inc. This article has been cited by other articles in PMC. Instruments Three instruments were used to screen patients for this study. Recruitment and Screening Faran Recruitment and screening procedures were designed to collect a carefully diagnosed sample of children and adolescents with severe CD.
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Design and Medication The patients were treated with risperidone in an open-label fashion for 8 weeks, starting at a daily dosage of 0.
Monitoring Adverse Events All patients underwent a complete review of current health status, which included a careful medical history. Statistical Analysis Data are reported as azmii SD. Table Mean behavioral ratings at baseline azml at end of treatment with risperidone. Open in a separate window.
Matched-pair t test for CGI global improvement subscale was conducted between the end of week 4 and the end of treatment. Subscale scores were calculated by summing the scores on the items of each subscale. Tolerability Assessment No severe adverse events were reported. Study Limitations The results of our study should be interpreted cautiously because of several limitations. Diagnostic and Statistical Manual of Mental Disorders. Practice parameters for the assessment and treatment of children and adolescents with vxran disorder.
American Academy of Child and Adolescent Psychiatry.