Risperidone In Children Research Articles

Acute Hyperkinetic Movement Disorders as a Multifactorial Pharmacodynamic Drug Interaction Between Methylphenidate and Risperidone in Children and Adolescents.

Acute hyperkinetic movement disorders have been reported with the concomitant use of attention-deficit/hyperactivity disorder (ADHD) stimulants and antipsychotics in children and adolescents. We analyzed postmarketing reports of suspected acute hyperkinetic movement disorder associated with concomitant use of ADHD stimulants and antipsychotics. We searched for postmarketing reports of acute hyperkinetic movement disorders associated with concomitant use of ADHD stimulants-antipsychotics in the US Food and Drug Administration Adverse Event Reporting System through December 6, 2019. PubMed and EMBASE were also searched for acute hyperkinetic movement reports with the concomitant use of ADHD stimulants-antipsychotics through January 13, 2020. We identified 36 cases resulting in acute hyperkinetic movement disorder associated with the concomitant use of ADHD stimulants-antipsychotics, 19 of which were also identified in the medical literature. From an ADHD stimulant perspective, methylphenidate products accounted for the largest number of cases (n = 23 [64%]), followed by amphetamine products (n = 9 [25%]) and atomoxetine (n = 4 [11%]). From an antipsychotic perspective, all 36 cases were reported with second-generation antipsychotics, particularly risperidone (n = 20 [56%]). Most of the cases were reported in boys (n = 31 [86%]) aged 6 to 12 years (n = 27 [75%]). Approximately 53% of the cases reported a time to onset within 24 hours of the drug change. Acute dystonic reactions (n = 27 [75%]) were the most frequently reported movement disorder. As outlined in changes to the US prescribing information for all methylphenidate and risperidone products, health care professionals should be aware that changes to this combination may be associated with a pharmacodynamic drug-drug interaction resulting in acute hyperkinetic movement disorder.

Review of the Long-Term Effect of the Atypical Antipsychotic Medication on the Bone Mineral Density of the Pediatric Patient with Consideration of Autism Spectrum Disorder

Objectives: To shed some light on the understudied complication of chronic prolonged exposure to antipsychotics (AP) in children with consideration to with autism spectrum disorder (ASD). Methods: We electronically searched PubMed, Google Scholar, clinical trial.gov, and Medline Database of clinical studies up to June 2021. We used the following keywords: “bone mineral density, osteoporosis, osteopenia, bone loss, bone changes” AND “antipsychotics, SGAs, atypical antipsychotics” AND “pediatric, adolescent, young, youth, children.” We used [Mesh] Term for “antipsychotics agent” and “bone mineral density” and “autism spectrum disorder” and “child.” We retrieved relevant observational studies, reviews, case series, and randomized clinical trials. Results: Yvette Roke et al., in 2012, reported in a retrospective observational study that lumbar spine bone mineral density (BMD) and the biochemical bone marker were lower in the AP-treated boy with hyperprolactinemia in comparison to the non-AP-treated group, while a retrospective observational study of institutional adolescents with a psychiatric condition, carried out by Bonnot et al. in 2011, found significant vitamin D deficiency in psychiatric inpatient adolescents that is unrelated to the specific APs. Third, Calarge et al. in a 2010 retrospective observational study have reported a significant reduction in BMD in adolescents with risperidone-induced hyperprolactinemia and selective serotonin reuptake inhibitor (SSRI) compared to another group with risperidone-induced hyperprolactinemia without SSRI. On the other hand, Nivin A. Nagiub et al. (2019) in the cross-sectional study found no correlation between BMD and AP use in children with ASD. Houghton et al., in 2021, found a high fracture prevalence of 38% with aripiprazole compared to risperidone in children with ASD. Conclusion: Clinicians should be aware of the potential negative effects of APs on BMD, considerably in children with ASD that has additional risk factors for osteoporosis and bone disease. A provider needs to utilize more sensitive screening and diagnostic tools; the pediatric physician should evaluate other risk factors to prevent early osteopenia and bone fracture in children with ASD who are on chronic psychotropic medication, before adjusting to the AP medication.

Effectiveness and Adverse Effects of Risperidone in Children with Autism Spectrum Disorder in a Naturalistic Clinical Setting at a University Hospital in Oman.

Objective This study aimed at examining the effectiveness of treating children with autism spectrum disorder (ASD) who present with irritability, aggression, and disruptive behavior at the Sultan Qaboos University Hospital (SQUH) in Muscat, Oman, with risperidone, and to note any sex-based differences among this cohort. Method This was a retrospective study conducted at the Department of Behavioral Medicine at SQUH over two years from January 2017 to December 2018. This study included all children aged 3 to 18 years attending the Child and Adolescent Mental Health Service (CAMHS) outpatient clinic with a diagnosis of ASD, based on the DSM-5 criteria, and comorbid disruptive behavior, who had been prescribed risperidone. Result This study identified 95 ASD patients (72 males). Male patients' BMI score after 12 months of risperidone treatment showed an increase by 0.62 (1.57 SD; P=0.001); however, there was no significant change among female patients. Somnolence was noted in 69.6% of female patients as compared to 34.7% of males (P=0.003). Among those with a family history of ASD, 5 out of 17 patients had treatment success (29.4%), whereas 70 out of 78 patients (90.0%) who did not have a similar history had successful treatment. Conclusion In conclusion, low-dose risperidone monotherapy is effective and well tolerated among some children with ASD who present with disruptive behavior in a naturalistic clinical setting. However, we found that some of the side effects, such as weight gain and somnolence, were concerning.

Baclofen as an adjuvant therapy for autism: a randomized, double-blind, placebo-controlled trial.

Increasing evidence suggests that the function of the GABAergic system is abnormally low in autism spectrum disorder (ASD). Baclofen, which functions as a selective agonist for GABAB receptors, does appear promising for the treatment of ASD. We conducted a 10-week randomized-controlled study aimed at evaluating the potential of baclofen as an adjuvant therapy to enhance the effect of risperidone in children with ASD. Sixty-four children (3-12years) with moderate-to-severe irritability symptoms of ASD were included. We used the Aberrant Behavior Checklist-Community Edition (ABC-C) for the outcome measures on each of the follow-up visits (weeks 0, 5, and 10). Analysis of the combined data revealed significant improvement for all the ABC subscales (irritability: F = 51.644, df = 1.66, p < 0.001, lethargy: F = 39.734, df = 1.38, p < 0.001, stereotypic behavior: F = 25.495, df = 1.56, p < 0.001, hyperactivity: F = 54.135, df = 1.35, p < 0.001, and inappropriate speech: F = 19.277, df = 1.47, p = 0.004). Combined treatment with baclofen and risperidone exerted a greater effect on improvement of hyperactivity symptoms at both midpoint [Cohen's d, 95% confidence interval (CI) = - 3.14, - 5.56 to - 0.72] and endpoint (d, 95% CI = - 4.45, - 8.74 to - 0.16) when compared with treatment with placebo plus risperidone. The two treatments achieved comparable results for other outcome measures. Our data support safety and efficacy of baclofen as an adjuvant to risperidone for improvement of hyperactivity symptoms in children with ASD.

No Differences in Weight Gain Between Risperidone and Aripiprazole in Children and Adolescents After 12 Months.

Weight gain due to the use of second-generation antipsychotics is a major health care issue for adult and paediatric psychiatric patients. Little is known about long-term weight gain effects of aripiprazole compared to risperidone in children and adolescents. The primary aim of this study is to assess whether risperidone and aripiprazole are associated with different weight changes in children and adolescents during the first 12 months of treatment. Secondary aim was to assess the influence of the covariates co-medication, gender and indication on weight change. This study was a retrospective observational cohort study of in- and outpatients of a Dutch mental health organization aged ≤19 years on long-term treatment with risperidone or aripiprazole. Primary outcome measure was body-mass index (BMI) z-score change. Data were extracted from medical charts and analysed using linear mixed models. In total, 89 risperidone patients and 42 aripiprazole patients were included in the study. At baseline, the BMI z-score of aripiprazole subjects was significantly higher than risperidone subjects (p = 0.003). In both treatment groups BMI z-score significantly increased during 12 months of follow-up. This weight change was not significantly different in risperidone and aripiprazole users after 12 months (p = 0.943). Covariates did not significantly influence weight change. This study demonstrated that there was no significant difference in weight gain between risperidone and aripiprazole users during the first year of treatment. Based on this study, aripiprazole should not be favoured over risperidone in children and adolescents because of the degree of weight gain.

CYP2D6 genotype and adverse events to risperidone in children and adolescents.

Background:There are few and conflicting data on the role of cytochrome P450 2D6 (CYP2D6) polymorphisms in relation to risperidone adverse events (AEs) in children. This study assessed the association between CYP2D6 metabolizer status and risk for risperidone AEs in children.Methods:Children ≤18 years with at least four weeks of risperidone exposure were identified using BioVU, a de-identified DNA biobank linked to electronic health record data. The primary outcome of this study was AEs. After DNA sequencing, individuals were classified as CYP2D6 poor, intermediate, normal, or ultrarapid CYP2D6 metabolizers.Results:For analysis, the 257 individuals were grouped as poor/intermediate metabolizers (n=33, 13%) and normal/ultrarapid metabolizers (n=224, 87%). AEs were more common in poor/intermediate versus normal/ultrarapid metabolizers (15/33, 46% vs. 61/224, 27%, P=0.04). In multivariate analysis adjusting for age, sex, race, and initial dose, poor/intermediate metabolizers had increased AE risk (adjusted odds ratio 2.4, 95% confidence interval 1.1-5.1, P=0.03).Conclusion:Children with CYP2D6 poor or intermediate metabolizer phenotypes are at greater risk for risperidone AEs. Pre-prescription genotyping could identify this high-risk subset for an alternate therapy, risperidone dose reduction, and/or increased monitoring for AEs.

Risperidone for children and adolescents with autism spectrum disorder: a systematic review.

BackgroundVarious clinical trials suggested that risperidone was beneficial in the treatment of autism spectrum disorder (ASD) in children and adolescents.ObjectiveThe aim of this systematic review was to determine the efficacy, acceptability and tolerability of risperidone in the treatment of children and adolescents with ASD.Data sourcesThe databases of Scopus, PubMed, CINAHL and Cochrane Controlled Trials Register were searched in February 2017.Study eligibility criteria, participants and interventionsEligible RCTs of risperidone in the treatment of child and adolescent patients with ASD. Languages were not restricted.Study appraisal and synthesis methodsThe full-text versions of relevant studies were thoroughly assessed and extracted. The primary efficacy of outcome was the pooled response rate and the pooled mean changed scores of the standardized rating scales for ASD.ResultsA total of 372 randomized subjects from seven RCTs were included in this review. In acute treatment, the pooled mean change score of the Aberrant Behavior Checklist for irritability subscale (ABC-I) and response rate for the risperidone-treated group had a greater significance than that of the placebo-treated group. In the long-term treatment, the pooled mean change score of the CARS in the risperidone-treated group was significantly greater than that in the placebo-treated group. According to the discontinuation phase, the overall pooled relapse rate of the risperidone-treated group was significantly less than that of the placebo-treated group. The rates of pooled overall discontinuation and discontinuation due to adverse events rates were not different between the two groups in acute and long-term treatments.LimitationsA small study was included in the current review.ConclusionIn relation to the current systematic review, risperidone is efficacious in the treatment of symptoms in children and adolescents with ASD. Although its acceptability is comparable to placebo, treatment with risperidone is well tolerated in children and adolescents with ASD.

Erratum to: Effectiveness, Adverse Effects and Drug Compliance of Long-Acting Injectable Risperidone in Children and Adolescents.

Although the use of oral risperidone in children and adolescents has been well studied, there is little information on the intramuscular use of long-acting injectable risperidone (LAIR). The aims of this study were to investigate the effectiveness and adverse effects of LAIR in children and adolescents with conduct disorder, bipolar disorder, and schizophrenia. In total, 42 patients (age range 12–17 years) who were non-adherent to oral antipsychotic drugs, received 25 mg of LAIR intramuscularly every 2 weeks. The drug was administered at least four times and up to 66 times (median drug use: 9.50 times). The effectiveness and adverse effects of the treatment were examined. There was an improvement in 13 (92.8%) of the 14 patients diagnosed with bipolar disorder, in 25 (78.1%) of 32 patients diagnosed with conduct disorder and in one (50%) of two patients diagnosed with schizophrenia. Six patients had comorbid conduct disorder and bipolar disorder. Totally, 81% of the patients improved with LAIR. Weight-gain, daytime somnolence, muscle stiffness and spasms, impaired concentration, and fatigue were the most common side effects through the whole sample. Menstrual problems were common in girls. In the study, 57.1% of the patients continued to receive their injections regularly until the end of the treatment, under physician control. A total of 16.7% discontinued the treatment due to non-adherence. The LAIR treatment was terminated in 26.2% of the patients, due to weight-gain, dystonia, and galactorrhea. In children and adolescents with conduct disorder, bipolar disorder and schizophrenia who show noncompliance with oral drugs, LAIR may improve treatment compliance. LAIR is a reliable treatment in terms of its effectiveness. Weight-gain, dystonia, and galactorrhea were the adverse effects that were responsible for LAIR treatment cessation.

Comparison of the effect of lithium plus quetiapine with lithium plus risperidone in children and adolescents with bipolar I disorder: a randomized clinical trial.

Background: In the treatment of bipolar disorder in youths, often more than one medication should be prescribed. In the current study, we compared the efficacy and tolerability of the combination of lithium and quetiapine with lithium and risperidone in the treatment of manic or mixed episodes in children and adolescents. Methods: Thirty patients (aged 10-18 years) who were hospitalized for a manic or mixed episode were recruited from consecutive inpatient admissions to the Child and Adolescent Psychiatric Unit at Razi Psychiatric Hospital (University of Social Welfare and Rehabilitation Sciences, Tehran, Iran) from June 2012 to September. They were randomly treated with lithium (with the usual dose to achieve blood levels 0.8-1) and quetiapine (400-600 mg per day) or risperidone (0.5-6 mg per day). The primary outcome measure with respect to efficacy was the mean decrease in Young Mania Rating Scale (YMRS) score. Side effects were also assessed. The independent t test and two-factor repeated measure analysis of variance (ANOVA) was used for data analysis. P-value of less than 0.05 was considered statistically significant. Results: The reduction in YMRS scores was similar in both groups. The remission rate (YMRS <12) in the group treated with quetiapine was 80% and with risperidone was 66.6%; the difference was not significant. The most common side effect was sedation in both groups. Extrapyramidal side effects were observed only with risperidone. Both drugs caused increased levels of prolactin. Conclusion: Both protocols were effective. Quetiapine in combination with lithium in manic or mixed episodes of bipolar I disorder in children and adolescents was not superior to lithium and risperidone, but was associated with fewer complications.

No Apparent Cardiac Conduction Effects of Acute Treatment with Risperidone in Children with Autism Spectrum Disorder.

Risperidone is approved for the treatment of serious behavioral problems in children with autism spectrum disorder (ASD). This study examined the effects of risperidone on cardiac conduction in children with ASD. Data were collected from an 8-week, five-site trial conducted by the Research Units on Pediatric Psychopharmacology Autism Network. Children (age 5-17 years) were randomly assigned to risperidone (n = 49) or placebo (n = 52) under double-blind conditions. Risperidone was superior to placebo in reducing serious behavioral problems. A standard 12-lead, electrocardiogram (ECG) was obtained in most subjects at screening and week 8. A pediatric electrophysiologist blind to treatment assignment reviewed all available ECGs for readability, abnormalities, and cardiac conduction parameters, including QTc. The electrophysiologist measurements were compared to machine readings. A second blinded electrophysiologist examined all available ECGs for abnormalities and a 20% random sample for QTc. Of the 101 randomized subjects in the trial, complete pretreatment and week 8 data were available on 65 subjects (placebo n = 30; risperidone n = 35). The electrophysiologist did not identify any cardiac conduction adverse effects of risperidone and there was no difference in mean change on the QTc compared to placebo. The Bland-Altman plot showed a systematic bias in QTc measurements by the electrophysiologist and machine. Machine readings produced higher values than the electrophysiologist for shorter QTc intervals and machine scoring was lower than electrophysiologist readings for longer QTc values (p = 0.001). Two electrophysiologists had overall percent agreements of 82.9% (95% CI: 76.3 to 89.6) on qualitative assessment and 88.6% (95% CI: 79.3 to 98.0) on QTc interval. Using conventional doses during acute treatment in children with ASD and serious behavioral problems, there was no difference in the mean change in QTc between risperidone and placebo. Compared to the electrophysiologist, the machine readings may miss elevated QTc measurements.

Prescribing pattern and monitoring of children with neuro developmental disorders who were treated with risperidone at Lady Ridgeway Hospital, Colombo

Background Behavioural disturbances are a common and challenging issue in the management of neurodevelopmental disorders in children. Treatment with pharmacological methods becomes necessary when these behaviours interfere with the general wellbeing and daily activities of these children, and with therapeutic programmess. There is a growing evidence base for the use of risperidone in this context. However the use of this medication is limited by its side-effect profile and the need for consistent and regular monitoring of these side-effects. Currently there is a paucity of data on the usage patterns of risperidone and its side-effect profile in children in Sri Lanka. Aims To analyse the prescribing patterns, indications and monitoring of risperidone in children with a primary diagnosis of a neurodevelopmental disorder who were prescribed risperidone. Methods This was a retrospective study carried out in University Psychological Medicine Unit, Lady Rideway Hospital for Children, Colombo (LRH). All children diagnosed with Neurodevelopmental disorders in the years 2013 and 2014 who were commenced on risperidone were included. Results A total of 27 children, 14 in 2013 and 13 in 2014 were prescribed risperidone. This amounted to 2.1% of the total number of referrals in 2013 and 2.6% in 2014. Majority were males (77.8%) and ages ranged from 4 years and 3 months to 13 years. The main diagnosis was attention deficit hyperactivity disorder (29%) and aggression was the commonest indication (40.74%). Initial weight of the patient was not measured in 59.3% and weight gain thereafter was monitored only in two patients. Other common side effects were not monitored. Tardive dyskinesia was reported in one child. Pre-treatment investigations were not done in a majority (92.59%). Post-treatment monitoring was not done in 44.4%. Conclusion Prescription of risperidone for neurodevelopmental disorders was found to be used very sparingly in this sample. Deficiencies in monitoring for side effects were identified highlighting the need for regular monitoring.

Minocycline as Adjunctive Treatment to Risperidone in Children with Autistic Disorder: A Randomized, Double-Blind Placebo-Controlled Trial.

This is an investigation of minocycline efficacy and safety as an adjuvant to risperidone in management of children with autism. Forty-six children with diagnosis of autistic disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria and a score of ≥12 on the Aberrant Behavior Checklist-Community (ABC-C) irritability subscale, who were already drug-free for at least 6 months participated in a randomized controlled trial and underwent 10 weeks of treatment with either minocycline (50 mg twice per day) or placebo in addition to risperidone titrated up to 2 mg/day (based on bodyweight). Patients were evaluated using ABC-C at baseline and at weeks 5 and 10. General linear model repeated measures showed significant effect for time × treatment interaction on the irritability [F(2, 88) = 3.94, p = 0.02] and hyperactivity/noncompliance [F(1.50, 66.05) = 7.92, p = 0.002], but not for lethargy/social withdrawal [F(1.61, 71.02) = 0.98, p = 0.36], stereotypic behavior [F(1.34, 58.80) = 1.55, p = 0.22], and inappropriate speech subscale scores [F(1.52, 66.88) = 1.15, p = 0.31]. By week 10, 21 (91.3%) patients in the minocycline group and 15 (65.5%) patients in the placebo group achieved at least partial response (p = 0.03). Frequencies of adverse events were not significantly different between groups. Minocycline seems to be a safe and effective adjuvant in management of patients with autistic disorder. Future studies with larger sample sizes, longer follow-ups, and inflammatory cytokine measurements are warranted to confirm these findings and provide insight into minocycline mechanism of action in autistic disorder.

Tolerability, Safety, and Benefits of Risperidone in Children and Adolescents with Autism: 21-Month Follow-up After 8-Week Placebo-Controlled Trial.

Risperidone has demonstrated efficacy for acute (8 week) and intermediate length (6 month) management of severe irritability and aggression in children and adolescents with autism. Less is known about the long-term effects of risperidone exposure in this population. We examined the tolerability, safety, and therapeutic benefit of risperidone exposure over a 1-2 year follow-up period. In a naturalistic study, 84 children and adolescents 5-17 years of age (from an original sample of 101) were assessed an average of 21.4 months after initial entry into a placebo-controlled 8 week trial of risperidone for children and adolescents with autism and severe irritability. They were assessed at baseline and at follow-up on safety and tolerability measures (blood, urinalysis, electrocardiogram [ECG], medical history, vital signs, neurological symptoms, other adverse events), developmental measures (adaptive behavior, intelligence quotient [IQ]), and standardized rating instruments. Treatment over the follow-up period, after completion of protocol participation, was uncontrolled. Statistical analyses assessed outcome over time with or without prolonged risperidone therapy. Two-thirds of the 84 subjects continued to receive risperidone (mean 2.47 mg/day, S.D. 1.29 mg). At follow-up, risperidone was associated with more enuresis, more excessive appetite, and more weight gain, but not more adverse neurological effects. No clinically significant events were noted on blood counts, chemistries, urinalysis, ECG, or interim medical history. Regardless of drug condition at follow-up, there was considerable improvement in maladaptive behavior compared with baseline, including core symptoms associated with autism. Height and weight gains were elevated with risperidone. Social skills on Vineland Adaptive Behavior Scale (VABS) improved with risperidone. Parent-rated Aberrant Behavior Checklist (ABC) Irritability subscale scores were reduced in those taking risperidone at follow-up. Several other measures of maladaptive behavior (some related to socialization) also showed improved functioning in association with risperidone on the ABC or on the Modified Real Life Rating Scale. Increased appetite, weight gain, and enuresis are risks associated with long-term risperidone. Our data suggest that these risks were balanced by longer-term behavioral and social benefits for many children over 1.8 years of ongoing treatment.

An open clinical trial of risperidone in children with seizures and hyperactivity

Children with seizures may also have behavioral problems including hyperactivity. The management of hyperactivity in these cases is complicated by the fact that pharmacotherapeutic interventions may worsen the seizures. In this study 10 children with epilepsy and attention deficit hyperactivity disorder were treated with risperidone in an open label fashion. The dose was titrated up from 0.5 mg to a maximum of 3 mg per day based on clinical efficacy and tolerability. Clinical improvement was noted in all the 10 patients. Tiredness was reported by one patient, and drowsiness by another, but none experienced extra pyramidal side effects. Furthermore, there were no untoward effects on the frequency or intensity of the seizures. Our findings suggest that risperidone in combination with anticonvulsant medication is safe and effective in treating children with seizures and hyperactivity. Controlled studies are needed to determine long-term efficacy and safety of this drug in this special population.

Participant Satisfaction in a Study of Stimulant, Parent Training, and Risperidone in Children with Severe Physical Aggression

The purpose of this study was to examine the satisfaction of families who participated in the Treatment of Severe Childhood Aggression (TOSCA) study. TOSCA was a randomized clinical trial of psychostimulant plus parent training plus placebo (basic treatment) versus psychostimulant plus parent training plus risperidone (augmented treatment) for children with severe physical aggression, disruptive behavior disorder, and attention-deficit/hyperactivity disorder. Parents completed a standardized Parent Satisfaction Questionnaire (PSQ). Of the 168 families randomized, 150 (89.3%) provided consumer satisfaction data. When they were asked if they would join the study again if they had the option to repeat, 136 (91%) said "yes," 11 (7%) said "maybe," and one (<1%) said "no." When asked if they would recommend the study to other parents with children having similar problems, 147 (98%) said "yes" and 3 (2%) said "maybe." Between 71% (rating one aspect of the Parent Training) and 96% (regarding the diagnostic interview) endorsed study procedures using the most positive response option. Asked if there were certain aspects of the study that they especially liked, 64 (43%) spontaneously reported parent training. Treatment assignment (basic vs. augmented) and responder status were not associated with reported satisfaction. However, responder status was strongly associated with parent confidence in managing present (p<0.001) and future (p<0.005) problem behaviors. These findings indicate high levels of satisfaction with TOSCA study involvement and, taken together with previous pediatric psychopharmacology social validity studies, suggest high levels of support for the research experience. These findings may inform research bioethics and may have implications for deliberations of institutional review boards. Treatment of Severe Childhood Aggression (The TOSCA Study), NCT00796302, clinicaltrials.gov .

Autistic Traits and Factors Related to a Clinical Decision to Use Risperidone in Children with Attention Deficit Hyperactivity Disorder

Amac: Calismanin amaci, ana tanisi dikkat eksikligi hiperaktivite bozuklugu (DEHB) olan cocuk ve ergenlerde risperidon kullanma kararini belirleyen faktorleri, DEHB’de otizme ozgu ozellikleri (OO) ve bu ozelliklerin tedavi tercihi uzerindeki etkilerini arastirmaktir. Yontem: Ozel bir cocuk-ergen psikiyatrisi kliniginde takip edilmekte olan, aldiklari tedaviye gore dort gruba ayrilan DEHB tanili cocuklar geriye donuk olarak karsilastirildi [ilacsiz tedavi, IT (n=73, ortalama yas=9.22±2.94 yil), sadece stimulan, S (n=184, ortalama yas=10.52±2.98 yil), sadece risperidon R (n=51, ortalama yas=10.18±3.52 yil), ve stimulan ve risperidon, SR (n=30, ortalama yas=9.37±2.71 yil)]. Yari yapilandirilmis klinik gorusmeye ek olarak, ilk degerlendirmede, ebeveyn tarafindan bir sosyodemografik form, Cocuklar icin Davranis Degerlendirme Olcegi-6-18 (CDDO-6-18) ve SNAP-IV (Swanson, Nolan and Pelham), ogretmen tarafindan ise SNAP-IV olceklerinin doldurulmasi istendi. Bulgular: CDDO toplam puani, dissallastirici problemler, sosyal problemler, dusunce problemleri, dikkat problemleri ve agresyon olcekleri T skorlarinda (butun p’ler < 0.05) ve ebeveyn tarafindan doldurulan SNAP dikkat eksikligi ve toplam puanlarinda gruplar arasi anlamli fark bulundu (tek yonlu ANOVA analizi). SR grubunun (i) CBCL’in sozu gecen alt olceklerinin puani, IT ve S gruplarindan yuksekti, (ii) CBCL sosyal problemler alt olcegi puanlari R grubundan yuksekti, (iii) ebeveyn tarafindan doldurulan SNAP dikkat eksikligi alt olcegi puanlari IT ve R gruplarindan yuksekti (iv) ebeveyn tarafindan doldurulan SNAP toplam puani diger uc gruptan yuksekti (Tukey post hoc testi). CBCL-OO esiginin uzerindeki 64 cocugun ebeveyn ve ogretmen tarafindan derecelendirilen DEHB belirti siddetleri, CBCL-OO esiginin altinda olanlardan daha yuksekti. Lojistik regresyon analizinde hekimin risperidon iceren bir tedaviyi (tek basina veya stimulanla birlikte) tercih etmesi CBCL sosyal problemler (p=0.025) ve dusunce problemleri (p=0.039) alt olcekleri ile iliskili bulundu. Kategorik olarak otistik ozelliklerin bulunmasi tedavi tercihiyle iliskilendirilemedi. Sonuc: Bu klinik orneklemde, CDDO ebeveyn bildirimindeki sosyal problemler ve dusunce problemlerinin, DEHB tanisi olan cocuklarda, hekimin tedavi icin risperidon kullanma karariyla iliskili oldugu gorulmektedir. Calismamizin sinirlari icinde, otistik ozellikleri olan cocuklarda DEHB belirtilerinin daha siddetli oldugu ve bu cocuklarda daha fazla ogrenme guclugu oldugu, ancak otistik ozelliklerin, bir kategori olarak alindiginda, risperidon kullanimi ile iliskili olmadigi anlasilmaktadir. DEHB’li cocuklarda DEHB disi belirtilerin ayrintisiyla tanimlanmasi (sosyal ya da emosyonel belirtiler vb.), sosyal gelisimi destekleme yaklasimlari gibi, bireysellestirilmis klinik mudahalelerin gelistirilmesini saglayarak, ayni belirtileri duzeltme amacli, dogrudan DEHB’ye donuk olmayan, ilaclara daha az basvurulmasini saglayabilir.

Relation between dosage, serum concentration and therapeutic response of risperidone in children and adolescents with schizophrenic psychosis: data from a routine TDM-Service

Relation between dosage, serum concentration and therapeutic response of risperidone in children and adolescents with schizophrenic psychosis: data from a routine TDM-Service

PMH81 - Use of aripiprazole and risperidone in children with autism: Effects of introducing an alternative new patented drug and debuting the first generic drug

PMH81 - Use of aripiprazole and risperidone in children with autism: Effects of introducing an alternative new patented drug and debuting the first generic drug

Adverse effects of risperidone in children with autism spectrum disorders in a naturalistic clinical setting at siriraj hospital, Thailand.

A cross-sectional study was conducted to evaluate adverse effects associated with risperidone in 45 children with autism spectrum disorders (ASD), aged 2–15 years, who were treated at Siriraj Hospital, Thailand, between the years 2006 and 2007. Adverse effects were assessed by parent interview, using a semistructure questionnaire, and medical records review. The mean ± SD age of the children at starting risperidone was 8.15 ± 2.98 years. The mean ± SD of risperidone dose was 0.94 ± 0.74 mg/day and the mean ± SD duration of treatment was 36.8 ± 27.8 months. Adverse effects were reported in 39 children (86.7%). Common adverse effects included increased appetite, somnolence, and rhinorrhea and most of the adverse effects were tolerable. Tardive dyskinesia or other serious adverse events were not found in this study. The child's mean ± SD weight gain was 4.18 ± 2.82 kg/year, which exceeded developmentally expected norms. The results from this study suggest that risperidone treatment in children with ASD is associated with frequent mild and tolerable adverse effects. However, excessive weight gain could be found to be a concerning adverse effect and weight monitoring is warranted when risperidone is being prescribed.

Paediatric European Risperidone Studies (PERS): context, rationale, objectives, strategy, and challenges

In children and adolescents with conduct disorder (CD), pharmacotherapy is considered when non-pharmacological interventions do not improve symptoms and functional impairment. Risperidone, a second-generation antipsychotic is increasingly prescribed off-label in this indication, but its efficacy and tolerability is poorly studied in CD, especially in young people with normal intelligence. The Paediatric European Risperidone Studies (PERS) include a series of trials to assess short-term efficacy, tolerability and maintenance effects of risperidone in children and adolescents with CD and normal intelligence as well as long-term tolerability in a 2-year pharmacovigilance. In addition to its core studies, secondary PERS analyses will examine moderators of drug effects. As PERS is a large-scale academic project involving a collaborative network of expert centres from different countries, it is expected that results will lead to strengthen the evidence base for the use of risperidone in CD and improve standards of care. Challenging issues faced by the PERS consortium are described to facilitate future developments in paediatric neuropsychopharmacology.Electronic supplementary materialThe online version of this article (doi:10.1007/s00787-013-0498-3) contains supplementary material, which is available to authorized users.