Avoidance of neuroleptic drug for at least 2 weeks after complete recovery from NMS and gradual titration of low dose and low potency neuroleptic trial of newer anti psychotic such as clozapine may be useful to prevent recurrence of NMS.

Dizziness and postural hypotension are well-known side effects of risperidone. Our patient had these side effects. As expected, EPS was not significant.

During an eight-week study of children with autism and problematic behaviors, risperidone was demonstrated to be superior to placebo in terms of irritability scores, CGI-I scale scores, and measures of aggression, tantrums, and self-injurious behavior. The benefits of risperidone in the treatment of autistic disorder in children appear to last at least six months, and discontinuation of treatment can worsen symptoms. Although no dyskinesias were witnessed during six months of therapy, weight gain and fatigue remained significant adverse effects.

Individuals with autism spectrum disorders demonstrate a pattern of brain activity during face discrimination that is consistent with feature based strategies that are more typical of nonface object perception.

The drug (Risperdal) was cited in a federal lawsuit filed earlier this month by a doctor who claims children have been harmed and even killed by the misuse of drugs he blames on aggressive marketing by drug manufacturers.

On October 6, the FDA approved a new indication for risperidone oral solution/tablets and orally disintegrating tablets (Risperdal and Risperdal M-TAB, made by Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson]), allowing its use for the treatment of irritability associated with autistic disorder in pediatric patients aged 5 to 16 years.

Risperdal, first approved by the FDA in 1993, is indicated for the treatment of schizophrenia and bipolar disorder. The company booked U.S. Risperdal sales of about $2 billion in 2003, according to market data firm IMS Health.

The objective of this review is to summarize the data about metabolic side effects of atypical antipsychotics in children. Original research articles about side effects of atypical antipsychotics used in children were reviewed. The data was obtained mainly through Medline searches, identifying articles focusing on the use of atypical antipsychotics in children. Forty studies that addressed the issue of metabolic side effects were selected. The use of atypical antipsychotics in children has been consistently associated with weight gain and moderate prolactin elevation, while only a few case reports address the issue of glucose dysregulation and dyslipidaemia. The risk of weight gain and hyperprolactinaemia might be higher in younger children. Other risk factors have also been associated with antipsychotic-induced metabolic disturbances. These changes seem to be reversible, at least in some cases. Metabolic side effects of atypical antipsychotics could lead to serious complications in children who are prescribed these medications. Serious considerations should be given before initiating treatment and consistent clinical monitoring is essential. More research is needed, especially regarding glucose dysregulation and dyslipidaemia.

The use of risperidone was associated with a decrease in several target behaviors in a majority of the participants. Other than weight gain and mild sedation, risperidone was well tolerated. There was no evidence of EPS or tardive dyskinesia.

RATIONALE: Subjects who view experimental procedures as worthwhile are more likely to participate in clinical trials and comply with study procedures. Designing studies that consider the consumer's perspective will help to forge a better alliance between participants and researchers. OBJECTIVE: Participant satisfaction is seldom assessed in pharmacological research. In this paper, we report on parent satisfaction in a randomized clinical trial in children with autistic disorder and severely disruptive behavior. METHOD: Parents of 101 children with autism who had participated in a multi-site 8-week double-blind clinical trial of risperidone were given a questionnaire at the end to elicit their perceptions of the appropriateness and acceptability of clinical trial procedures. RESULTS: Ninety-six (95.0%) parents returned the questionnaire. Of these, 80.0 to 96.8%, depending on the question, expressed satisfaction with their child's research participation regardless of treatment outcome or assignment to active drug or placebo. In all, 90.5% of parents indicated that they would "definitely" recommend the clinical trial to other families with similar children. A total of 92.7% indicated that they would rejoin the clinical trial if they had to do it all over again. Ethnic minority subjects were more satisfied than white participants with the use of "learning tests". CONCLUSIONS: Parents of children participating in this trial were highly satisfied and supportive of the clinical trial procedures. Random assignment to drug or placebo and the clinical response of their children did not appear to influence their views. Further satisfaction studies of this sort are encouraged.

Risperidone (ris-PER-i-done) is used to treat the symptoms of psychotic disorders, such as schizophrenia. It is prescribed by a physician and often used to treat the aggressive behavior of autism.

An NAS Surrey member explains how Risperidone helped her son's behaviour.

Risperidone may help treat the serious behavioral disturbances that accompany autism and closely related disorders such as pervasive developmental disorder (PDD).

Risperidone has therapeutic effects involving both dopamine and serotonin activity. Several studies have reported on its effectiveness in the treatment of destructive behaviors associated with autism and other developmental disabilities.

Risperidone reduces aggression and tantrums in children with autistic disorder, but effects on core symptoms (impaired communication and social relatedness, as well as stereotyped behaviors) have not been established. The investigators pointed out that their modified rating instruments have not been established as valid and reliable. They concluded that risperidone treatment of autistic disorder in children and adolescents improves repetitive and stereotyped behaviors, a core domain of autistic disorder, but not impairments in communication and social interaction.

Dr. Jeffrey L. Rausch and colleagues from the Medical College of Georgia, Augusta, note that risperidone effectively treats the negative symptoms of schizophrenia. They enrolled 13 male patients between the ages of 6 and 18 years from March 13, 2002 to August 11, 2003 in a 12-week, prospective, open-label study. All of the patients were started on risperidone 0.25 mg twice/day, and doses were increased based on response and tolerability.

Subjects who were taking risperidone (mean dosage: 0.04 mg/kg/day; 1.17 mg/day) experienced a significantly greater mean decrease on the irritability subscale of the ABC (primary endpoint) compared with those who were taking placebo.

We want the clinicians to be aware of the possibility of patients developing TD when they are given the supposedly safe neuroleptic risperidone.

Tantrums, aggressive behaviour and self injury were all reduced in children with severe autism who were treated with the atypical antipsychotic risperidone, according to research presented here. The 8-week study by the Research Units on Pediatric Psychopharmacology (RUPP) Autism Network, a multicenter collaboration, was presented on October 24th at the 18th European College of Neuropsychopharmacology (ECNP) Congress.

OBJECTIVE: Risperidone is effective for short-term treatment of aggression, temper outbursts, and self-injurious behavior in children with autism. Because these behaviors may be chronic, there is a need to establish the efficacy and safety of longer-term treatment with this agent. METHOD: The authors conducted a multisite, two-part study of risperidone in children ages 5 to 17 years with autism accompanied by severe tantrums, aggression, and/or self-injurious behavior who showed a positive response in an earlier 8-week trial. Part I consisted of 4-month open-label treatment with risperidone, starting at the established optimal dose; part II was an 8-week randomized, double-blind, placebo-substitution study of risperidone withdrawal. Primary outcome measures were the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression improvement scale. RESULTS: Part I included 63 children. The mean risperidone dose was 1.96 mg/day at entry and remained stable over 16 weeks of open treatment. The change on the Aberrant Behavior Checklist irritability subscale was small and clinically insignificant. Reasons for discontinuation of part I included loss of efficacy (N=5) and adverse effects (N=1). The subjects gained an average of 5.1 kg. Part II included 32 patients. The relapse rates were 62.5% for gradual placebo substitution and 12.5% for continued risperidone; this difference was statistically significant. CONCLUSIONS: Risperidone showed persistent efficacy and good tolerability for intermediate-length treatment of children with autism characterized by tantrums, aggression, and/or self-injurious behavior. Discontinuation after 6 months was associated with a rapid return of disruptive and aggressive behavior in most subjects.

Risperidone was well tolerated and effective in treating behavioral problems in autistic children, according to the results of a multisite, double-blind, randomized trial reported in the Aug. 1 issue of New England Journal of Medicine. However, long-term safety has not been established.

A systematic review of randomized controlled trials of the use of atypical antipsychotics and selective serotonin reuptake inhibitors in the treatment of behavioural problems associated with pervasive developmental disorders is reported. A search through both published and unpublished literature, including contacting drug companies and known experts in the field was undertaken. Six trials met the criteria for inclusion in the review. They largely suffer from methodological weaknesses; only two trials had satisfactory methodological quality. The heterogeneity in outcome measurements prevented from conducting a meta-analysis. There is yet no coherent body of data concerning the effects of these medications across all sub-classifications of pervasive developmental disorders, across all age categories, and concerning their medium- and long-term effects, and their effects on quality of life. Atypical antipsychotics and selective serotonin reuptake inhibitors may be of benefit for behavioural problems associated with pervasive developmental disorders. Risperidone has been the best studied among these medications. Atypical antipsychotics appear to have a low risk of extrapyramidal symptoms during short-term treatment. The reviewed trials cannot provide data on the use of selective serotonin reuptake inhibitors in the treatment of children with pervasive developmental disorders. No firm conclusions for clinical practice can be drawn. Larger, well-conducted randomized controlled trials with long-term follow-up are needed.