Potential Areas of in Risperidone - Research Paper Example

? POTENTIAL AREAS OF RESEARCH IN RISPERIDONE Written by Presented to [mentor In partial fulfillment of the requirements of [program name] [university name] [date] POTENTIAL AREAS OF RESEARCH IN RISPERIDONE Findling et al have conducted a very important study related to the use and efficacy of risperidone in children with severe disruptive behaviors and below average IQs. Risperidone is among the second generation antipsychotics, which has been advocated for use as an antipsychotic drug (Eapen and Guraraj, 2005). Low doses of risperidone have been proposed to decrease aggressive behavior among children suffering from conduct and behavioral disorders. The drug acts by blocking the postsynaptic function of dopamine and serotonin receptors in the brain, however, how it is able to improve the behavior is still unknown (McCracken et al, 2002). These drugs enhance protection against extrapyramidal symptoms (Findling, 2003). This is one of the prime reasons why risperidone is used more frequently for the treatment of behavioral disorders among children (Risperidone in Children with Autism, 2002). So far, it is one of the few drugs that have been approved by the Food and Drug Administration or FDA to treat aggressive behavior and irritability among children with autism (Buck, 2008). This approval was expanded in 2007 to include treatment of cases suffering from bipolar disorder in children 10 years of age, and children with schizophrenia 13 years of age and over (Buck, 2008). The recommended dosage in children is less than 1 mg per day, which can be given once or twice daily. The drug takes at least one week to start showing its effects, where the child may become calmer and less aggressive in nature (Eapen and Guraraj, 2005). The duration of the drug is variable, and is prescribed based on individual needs. Studies are showing positive correlation between the uses of the drug and lessening of the effects of aggression among children (Eapen and Gururaj, 2005, McCracken et al, 2002). A common side effect of the drug is EPS or extrapyramidal side effects, which include muscle rigidity, eye rolling and restlessness (Eapen and Gururaj, 2005). Usually the EPS is reversed by the administration of diphenhydramine 25 mg, within half an hour of the episode. There is still somewhat limited number of studies about the side effects of the drugs and more research in this area is needed. Children with ADHD receiving the drug for a prolonged time are likely to display tardive dyskinesia, which is reversible after discontinuation of the drug (Robb, 2010). Other less common side effects include muscle spasms and stiffness, agitation and feeling of restlessness, difficulty in swallowing, unexplained fever confusion, and fast and irregular heartbeat respectively. Children can also rarely display high blood sugar levels, increased prolactine horomones and high blood lipid levels (Eapena dn Gururaj, 2005). Risperidone increases appetite and sleep, which is why it is of concern in obese children. Other probable side effects may include increased risk to metabolic syndrome, diabetes or increased lipids. These effects can be utilized for children who have low appetite or who are restless and difficult sleepers (Eapen and Gururaj, 2005). The selection of the topic for research is justified. There is need to expand the research and learn more about the mechanism of action of the drug, and how it affects the behavioral problems among children. Alongside, new research in the same area will help in reinforcing the already found conclusions as well as identify possible new areas of research, such as how to reduce the side effects of the drug among children. As stated in the study by Eapen and Gururaj, (2005), ‘Although psychostimulants remain the mainstay of pharmacological treatment for ADHD, they may not be tolerated by some children, may be ineffective in some, and in yet others may exacerbate a comorbid medical condition such as seizures or tics’(Eapen and Gururaj, 2005, pp 224). The same study states, ‘most of the conventional antipsychotics used in these situations do not combat persistant irritability, extreme aggression, and other maladaptive behaviors, which often coexist in children with developmental disorders’(Eapen and Gururaj, 2005, pp 224). The number of researches carried out on risperidone and its effects has so far been limited in the time frame. In this regard, new researches which study the effects of the drug for longer time period among children will help identify any effects that have been overlooked. Alongside, the long term studies will help in identifying the highest amount of dose that can be administered safely among children. The study clearly aims to study the effects of risperidone in long term among children with developmental disabilities and disruptive behavior disorders. However, the introduction and the thesis statement fail to clarify whether there have been many researches of the same sort conducted before. Although the researchers have pointed the challenges to the study very well, they have failed to identify any long term researches. If the presence or absence of these researches was acknowledged, it would have provided a much clearer perspective to the potential importance of the study. The hypothesis does not present itself very well. What is the need to carry out long term research on the use of risperidone. Already there are many researches on the topic. Then what significant difference does this particular approach give to the already present research. Again the lack of discussion about the presence or absence of long term research is a very important reason why this area is not self explanatory. The biggest limitation of the study perhaps is the inclusion of patients who were already involved in a pervious trial on risperidone. This means that the children were already taking the drug, and therefore, the complete picture, that is from the commencement of the drug to the last dosage taken are not completely assessed. The children in other words present themselves during a stage where they already have derived some benefit or adverse effect of the drug. Therefore, the true impact of the drug from the first point A till the last point remains unidentified. Second, those children who suffered from side effects of the drug were excluded. In this way, the complete segregation of the percentage of children who may suffer from the long term use of risperidone in the form of side effects may not be properly identified. The number of subjects is adequate, which makes it a significant study for finding results, which remains one of its strong points. Another concern when looking at the selection criteria is presented. The patient pool included patients with mild to moderate mental retardation. Therefore, the results may be somewhat limited for the dosage of children with mental retardation. This on the other hand can be considered as a beneficial aspect of the study; however, this part should have been mentioned more clearly in the hypothesis and mission statements. The study however, is well organized, with clear guidelines about the selection criteria, which assures one that the patients were very much similar in the severity of their mental condition. The DSM-IV axis remains one of the cornerstones in personality assessment. According to this scale, there are three disruptive behavior disorders. These are conduct disorders, oppositional defiant disorder and disruptive behavior disorder not otherwise specified (Findling, 2003). The use of the Stanford-Binet and Wechsler Intelligence Scales both are reliable indicators of the children’s IQs. The Nisonger Child Behavior Rating Form was used in the study for effectiveness analysis. The behavioral as well as the social component are both useful to assess the behavioral and cognitive changes among the subjects. The research provides substantive evidence and evaluation of the results, by categorizing it in different aspects. This helps in clarifying the linkages between different aspects and findings, to create a fuller understanding of the impact. The ethical perspective of the study was well taken care of. The detailed and tabulated evaluation of the results is indeed very helpful. A major concern arises with the use of risperidone as open labeled when the previous trial was double blind placebo. This means that some of the patients may have been receiving the drug before others. Will this affect the outcome of the efficacy of the drug, when compared to those children who had not received the drug? More so, the previous research does not help identify cases who received the drug, in order to make adjustments in the new trial. This creates some concerns to the true efficacy of the drug. The drug was given systematically, by increasing the dosage gradually, which made it an effective technique. Another concern is the use of other drugs “under restricted conditions”. Since these drugs are also psychostimulant, that is, affecting the brain, can the results be considered as the sole effect of the drug risperidone? Again, the research does not identify whether the children were taking any medication even prior to the first double blind placebo trial. If so, were they receiving any medication for their extra pyramidal effects? The safety assessments were properly carried out and well planned. The intervals were well timed to study the efficacy of the drug risperidone. The EEG assessments in timely intervals were helpful in identifying changes taking place in the children. Descriptive analysis was applied to the study. Again, the inclusion of all the subjects, whether received risperidone during the double trial study, questions the full results achieved. Even thought the data from these patients was analyzed and assessed, the true effect of the drug given previously remains unassessed. The paired t test has been utilized in the study. Overall, the final number of patients who remained in the study was mostly composed of boys. This study may therefore, provide a ground work for studies regarding the effect of risperidone on both sexes individually. Since half of the study subjects were receiving psychostimulants alongside risperidone, one needs to assess the effect on the final outcomes among children who did not receive psychostimulants versus those who did receive these. The safety issues are perhaps a main concern in the overall study, since over 90% of the subjects showed one or the other adverse effect. Although most of these side effects were mild to moderate in nature, there are numerous researches that point towards the adverse effects of the drug. This again can lead to questions of whether the use of risperidone is safe in children. Surprisingly, most of the studies do study the results of the use of the drug, but not the safety aspects. The only common feature related to safety in trials of risperidone are that subjects who show adverse effects are either put off the drug, or they are given other psychostimulants to counter the effects. There should be more studies that focus more on the safety of the drug both in short and long term. Three most common side effects are seen among children after the use of risperidone. The first is the increase in prolactin levels. In this study, the same side effect was observed. Among boys, the maximum level of prolactin achieved was 27.6ng/ml, where as in female, the same was 23.9 ng/ml respectively. Approximately 9.3% of the patients demonstrated an increase in appetite, where as weight gain was seen in 20.6% of the patients. Children have shown comparatively higher rates of obesity and weight gain than adults using the same drug. Therefore, such children should be involved in physical activity in order to prevent weight gain (Findling, 2003). Future studies can try to assess if the use of risperidone be carried out without any adverse effects. The cognitive aspects of the results showed the desired response predicted by the researchers. Improvement in the cognitive scores among children was indicative of the efficacy of risperidone. The discussion reveals the discontinuation rate within normal range of the open end clinical trials. There are very limited placebo controlled trials on risperidone among autism children, or any other behavioral disorders. Therefore, this research will provide one of the first initiatives in carrying out researches of the same style (Risperidone in Children with Autism, 2002). It also justifies the preponderance of male subjects in the study due to higher rates of disruptive disorders among males. The discussion mainly addresses the findings of the results and places various references in support of it. However, as mentioned above, these should be critically evaluated to find new areas of research. CONCLUSION The study was able to verify the benefits of using risperidone in the treatment of aggressive behavior among children with mild to moderate behavioral problems. There is need to carry out more researches that study the side effects of risperidone in children. REFERENCE Buck ML, 2008.Use of RIsperidone in Children with Autism, Bipolar Disease or Schizophrenia. Accessed on March 10th, 2011 from http://www.medscape.com/viewarticle/571416 Eapen Valsamma and Gururaj AK, 2005. Risperidone Treatment in 12 Children With Developmental Disorders and Attention-Deficit/Hyperactivity Disorder. Prim Care Companion J Clin Psychiatry:7;221-224. Findling Robert L, 2003. Treatment of Aggression in Children. Primary Care Companion J Clin Psychiatry 5[Suppl 6]: 5-9. Robb AS, 2010. Pharmacotherapy for Aggression in Children and Adolescents Psychiatric Annals 40:4, pp 231-236. Risperidone in Children with Autism and Serious Behavioral Problems. The New England Journal of Medicine Vol 347, No. 5, pp 314-321. McCracken JT,McGough J, Shah B,Cronin P, Hong D, Aman MG, Arnold LE, Lindsey R, Nash P, Hollway J, McDougle CJ, Posey D et al, 2002. Risperidone in Children with Autism and Serious Behavioral Problems. N Engl J Med 1; 347(5):314-321. Read More