Prenatal exposure to opioids: Associations between the caregiving environment and externalizing behaviors.

Maternal opioid use during pregnancy is a rapidly growing public health crisis and is associated with a range of adverse developmental outcomes including externalizing behaviors among exposed children. Recent work has highlighted the role of indirect pathways from prenatal opioid exposure to behavioral outcomes through aspects of the caregiving environment, including parenting. This review highlights maternal sensitivity and related aspects of the caregiving environment that may impact the development of externalizing behaviors among children with a history of prenatal exposure to opioids. We conclude by providing suggestions for future directions in research examining development among children with prenatal opioid exposure.

Potential therapeutic uses of cannabinoids to treat behavioural problems in children and adolescents with developmental disorders.

BACKGROUND: There is a great deal of interest in the potential symptomatic benefits of medicinal cannabis among parents of children and adolescents with developmental disorders. OBJECTIVE: This article provides an overview of what is known about medicinal cannabis as a treatment for paediatric developmental disorders. DISCUSSION: While there is emerging evidence in support of medicinal cannabis for some adult mental health disorders, to date the evidence in children and adolescents is scant. Reports from uncontrolled observational studies suggest that cannabidiol-rich products may be helpful in reducing behavioural problems in autistic youth. Cannabidiol appears to have a relatively benign adverse effect profile and therefore may be worth considering as a treatment option in some cases. Several controlled clinical trials are underway that will provide more definitive information on the therapeutic value of medicinal cannabis in paediatric developmental and behavioural disorders.

Use of Cannabis in Fetal Alcohol Spectrum Disorder.

Background: Fetal alcohol spectrum disorder (FASD) has been recently estimated to afflict up to 5% of American children. Most of these children exhibit different degrees of symptomatology of disruptive behaviors. Yet, there has been very little research on the efficacy and safety of pharmacological modalities, limited mostly to stimulants for attention deficit hyperactive disorder or second generation atypical antipsychotics for aggression. Recently, the use of cannabinoids has been described for symptoms related to autistic spectrum disorder with apparent favorable effects, as well as for other disruptive behaviors. The objective of our study was to follow up in a retrospective case series the effect of cannabis in children and young adults diagnosed with FASD. Methods: In two children and three FASD young adults with severe disruptive behavior, changes in behavior after cannabis use were measured by the parent version of the Nisonger Child Behavior Rating Form. Results: In all five cases, there was a highly statistical decrease in the disruptive behavior score from 18±1.0 before cannabis use to 6±2.1 after introduction of cannabis (p=0.0002). Discussion: In children and young adults with FASD, cannabis, mostly cannabidiol (CBD), has been associated with a marked and statistically significant improvement in serious disruptive behavior. These cases suggest that the efficacy and safety of CBD should be tested in well-controlled studies.

Autonomic functioning among cocaine-exposed kindergarten-aged children: Examination of child sex and caregiving environmental risk as potential moderators.

The purpose of this study was to examine the hypothesis that child sex moderates the association between prenatal cocaine exposure (PCE) and autonomic functioning as well as to examine the role that caregiving environmental risk played in sex differences in autonomic functioning among exposed children. Measures of the parasympathetic nervous system (indexed by respiratory sinus arrhythmia [RSA]) and the sympathetic nervous system (indexed by skin conductance level [SCL]) were obtained from 146 (75 cocaine-exposed, 38 male; and 71 nonexposed, 36 male) children during baseline and a task designed to elicit negative affect (NA). We also examined the role of caregiving environmental risk as a moderator of the association between PCE and autonomic functioning separately for boys and girls. PCE boys had a significantly higher baseline RSA and lower baseline SCL than PCE girls or nonexposed children. Environmental risk also moderated the association between PCE and baseline RSA for boys, but not girls, such that boys with PCE and high environmental risk had the highest baseline RSA. These findings indicate that exposed boys had significantly lower levels of sympathetic activation while at rest. However, for autonomic reactivity, the exposed girls had a larger change in both RSA and SCL relative to nonexposed girls while exposed boys had significantly smaller increases in SCL during environmental challenge. Finally, girls with both PCE and high environmental risk had the highest levels of parasympathetic reactivity during challenge. These results underscore the importance of examining sex differences and considering comorbid environmental risk factors when examining developmental outcomes in cocaine-exposed children and highlight the complexity involved with understanding individual differences in cocaine-exposed populations.

Does cannabidiol reduce severe behavioural problems in children with intellectual disability? Study protocol for a pilot single-site phase I/II randomised placebo controlled trial.

INTRODUCTION: Severe behavioural problems (SBPs) are a common contributor to morbidity and reduced quality of life in children with intellectual disability (ID). Current medication treatment for SBP is associated with a high risk of side effects. Innovative and safe interventions are urgently needed. Anecdotal reports and preliminary research suggest that medicinal cannabis may be effective in managing SBP in children with developmental disabilities. In particular, cannabidiol (CBD) may be a plausible and safe alternative to current medications. Families who are in urgent need of solutions are seeking cannabis for their ID children with SBP. However there is no evidence from randomised controlled trials to support the use of CBD for SBP. This pilot study aims to investigate the feasibility of conducting a randomised placebo-controlled trial of CBD to improve SBP in children with ID. METHODS AND ANALYSIS: This is a single-site, double-blind, parallel-group, randomised, placebo-controlled pilot study of 10 participants comparing 98% CBD oil with placebo in reducing SBP in children aged 8-16 years with ID. Eligible participants will be randomised 1:1 to receive either CBD 20 mg/kg/day or placebo for 8 weeks. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, study visit attendance, protocol adherence and the time burden of parent questionnaires. Safety outcomes and adverse events will be recorded. All data will be reported using descriptive statistics. These data will inform the design of a full scale randomised controlled trial to evaluate the efficacy of CBD in this patient group. ETHICS AND DISSEMINATION: This protocol has received ethics approval from the Royal Children's Hospital ethics committee (Human Research Ethics Committee no. 38236). Results will be disseminated through peer-reviewed journals, professional networks, conferences and social media. TRIAL REGISTRATION NUMBER: ACTRN12618001852246.

Impact of Omega-3 Fatty Acids Among Other Nonpharmacological Interventions on Behavior and Quality of Life in Children with Compromised Conduct in Spain.

The aim of this study was to assess the impact of omega-3 fatty acid supplementation among other nonpharmacological treatments on mental health and quality of life (QOL) of children with behavioral disorders. An observational multicenter study of 6- to 12-year-old children with behavior-related problems was performed in Spain with a three-month follow-up assessment. The Kidscreen-10 and Strengths and Difficulties Questionnaires (SDQ) were used to assess effectiveness of each intervention. Characteristics of study population were compared with those of the general population. Subanalyses of two homogenous subgroups, who received versus did not receive dietary supplementation with omega-3 fatty acids, were performed. The study included 942 children (69.1% male) with a mean (SD) age of 8.5 (1.8) years. Overall, patients' health status and QOL significantly improved at three months (p < .001). Scores on the SDQ also improved, with significant reductions on all subscales (p < .05). Comparison of SDQ results with the same-age general population showed higher overall scores in the study population (8.5 [5.5] vs. 18.6 [8.1], respectively) and on all the subscales (p < .001 in all cases). The omega-3 fatty acid supplementation subgroup presented greater improvements in each category of SDQ (p < .05), except for the emotion subscale. Omega-3 fatty acid supplementation alone or in combination with other nonpharmacological treatments is effective in improving children's mental health. Overall, nonpharmacological recommendations currently made by pediatricians seem to be effective in improving the perceived health status and patients' QOL and in the reduction of health problems, especially hyperactivity/inattention and conduct problems.

Review of the clinical approach to the treatment of disruptive mood dysregulation disorder.

Though a decade of research led to the creation of disruptive mood dysregulation disorder (DMDD), it was not until the 2013 publication of the DSM-5 that DMDD became an official diagnosis. The conception of DMDD was largely due to increasing rates of paediatric bipolar disorder (PBD) diagnoses, which significantly impacted treatment for these youth. The core symptoms of DMDD include persistent irritability and recurrent outbursts; the absence of a previous diagnostic category for youth experiencing these symptoms may have led to the over diagnosis of PBD. Due to the chronicity of symptoms, these youth are impaired in multiple areas of functioning. This article will present background information about DMDD, discuss clinical assessment strategies including scales for measuring irritability and aggression, and review pharmacologic and psychosocial treatments for youth with DMDD and clinical phenotypes similar to DMDD.

[Use of antipsychotics in children; too much or too long?] / Antipsychoticagebruik onder kinderen.

Antipsychotics have an important role in the treatment of children with severe behavioural problems. Use of antipsychotics in the Netherlands increased dramatically up until 2009. In recent years, however, the side-effects of antipsychotics in children have received increasing attention. One in eight children uses antipsychotics for at least 4 years. This long-term use increases the risk of side-effects, but these are often not optimally monitored. There should also be more attention for the timely tapering off of antipsychotics in children.

A Prospective Study of the Safety and Effectiveness of Droperidol in Children for Prehospital Acute Behavioral Disturbance.

Study objective: Although uncommon, children (<16 years) with acute behavioral disturbance are a significant issue for emergency medical service providers. In this study, we aimed to investigate the safety and effectiveness of droperidol in children with prehospital acute behavioral disturbance. Methods: This was a prospective observational study over 1 year investigating the use of droperidol (0.1-0.2 mg/kg) for children (< 16 years) with acute behavioral disturbance. Inclusion criteria for acute behavioral disturbance were defined by a sedation assessment tool score of ≥2 determined by the attending paramedic. The primary outcome was the proportion of adverse effects (need for airway intervention, oxygen saturation <90% and/or respiratory rate <12, systolic blood pressure <90 mmHg, sedation assessment tool score of -3 and dystonic reactions). Secondary outcomes included time to sedation (sedation assessment tool score decreased by 2 or more, or a score of zero), requirement for additional sedation, failure to sedate and proportion of sedation success defined as the number of patients successfully sedated who did not suffer any adverse events or receive additional sedation. Results: There were 96 patients (males 51 [53%], median age 14 years [range 7-15 years]) who presented on 102 occasions over the one year study period. Self-harm and/or harm to others was the commonest (74/105 [70%]) cause of acute behavioral disturbance followed by alcohol (16/105 [15%]). There were 9 adverse events in 8 patients (8/102 [8%]; 95% confidence intervals [CI]: 3-13%) Five patients had hypotension, all asymptomatic and only one required treatment; 2 dystonic reactions managed with benztropine and one patient with respiratory depression. Median time to sedation was 14 min (interquartile range (IQR): 10-20 min; range: 3-85 min). There was no requirement for prehospital additional sedation (0/102 [0%]; 95% CI: 0-4%) and additional sedation in the first hour of arrival to hospital was required by 4 patients (4/102 [4%]; 95% CI: 1-10%). Overall successful sedation was achieved in 89 (87%) patients. Conclusions: The use of droperidol in children for acute behavioral disturbance in the prehospital setting is both safe and effective.

Clonidine exposures in children under 6 (2004-2017): a retrospective study.

OBJECTIVE: To describe trends in clonidine exposures in children under 6. Clonidine has become increasingly popular for management of paediatric behavioural disorders. Clonidine has a narrow therapeutic index, and toxicity can occur with inadvertent double dosing. Clonidine is not recommended for use in children under 6 years. DESIGN AND SETTING: A retrospective review of clonidine exposures in children under 6 reported to the New South Wales Poisons Information Centre (NSWPIC, Australia's largest poison centre), 2004-2017. This was compared with community clonidine utilisation using dispensing data from Australian Statistics on Medicines, 2004-2015. Australian trends were compared with clonidine exposure calls to US poison centres, 2006-2016. MAIN OUTCOME MEASURES: Trends in poisonings and dispensing; demographics, dose, exposure type, clonidine source, symptoms, disposition. RESULTS: There were 802 clonidine exposures in the NSWPIC database, increasing 4.9% per year, 2004-2017 (95% CI 3.1% to 6.7%, p<0.001), correlated with increased dispensing, r=0.846 (95% CI 0.529 to 0.956, p<0.001). 78.6% were hospitalised and medical toxicologists were consulted in 7.2%, indicating high risk and/or morbidity. Clonidine was prescribed for the patient in at least 27.8%, providing evidence for prescribing outside of recommendations. US data reveals 19 056 clonidine exposures, with 3.7% increase per year, 2006-2016 (95% CI 2.2% to 5.3%, p<0.001). CONCLUSIONS: Clonidine exposures in children under 6 are increasing, and this trend is not isolated to Australia. Exposures have a high hospital referral rate and high morbidity. Caution should be exercised when prescribing clonidine, and parent/carer education is important for safe storage and increased vigilance when dosing.

Therapeutic itinerary of children living with epilepsy in Kinshasa: Features, determinants, and relationships with behavioral problems and cognitive impairment.

BACKGROUND: Epilepsy mostly affects children in sub-Saharan Africa. However, little is known about the therapeutic itinerary of these children living with epilepsy (CWE). This study aimed to describe the therapeutic itinerary of CWE in Kinshasa and to analyze its relationships with clinical features, behavioral problems, and cognitive impairment. METHODS: This hospital-based study has included 104 CWE aged 6 to 17  years. The features of their therapeutic itinerary and their relationship with clinical features, behavioral problems, and cognitive impairment were analyzed. RESULTS: The vast majority of CWE (87%) has started their therapeutic itinerary by the Western medicine. The first source of information about epilepsy as well as the type of antiepileptic treatment varied with the socioeconomic status of families of CWE. The total duration of the therapeutic itinerary was shorter for the CWE who were living with both their parents (P = .038), who had generalized seizures (P = .0073) or who had no family history of epileptic seizures (P = .019). The CWE who had total behavioral problem, compared with the others, were putting more time (P = .021) to reach the Centre de Santé Mentale Telema (CSMT) after the suspicion or the diagnostic of epilepsy. The total duration of CWE who had cognitive impairment (P = .021) was longer than that of CWE who had not cognitive impairment. CONCLUSION: The therapeutic itinerary of CWE in Kinshasa began with Western medicine. The remainder of this therapeutic itinerary looks like what is described in sub-Saharan literature with the majority of CWE seeking the healing based on beliefs. This study also shows that the therapeutic itinerary of CWE was associated with socioeconomic conditions, clinical features, behavioral problems, and cognitive impairment.

What do we really know about PRN use in agitated children with mental health conditions: a clinical review.

What is the evidence that 'pro re nata' (PRN) medication is effective for ending agitated outbursts in children and adolescents in psychiatric emergency rooms or inpatient units? Literature search was performed for studies of PRN medication use in children and adolescents that included an outcome measure. One randomised controlled trial, three prospective studies and six retrospective studies that included some outcome measure were identified. Outcome measures were heterogeneous, and frequently did not use standardised metrics assessing agitation level to measure effectiveness. The single small Randomized Controlled Trial (RTC) does not find a difference between placebo and medication, and outcomes of other studies do not control for potential placebo effect of the intervention itself as opposed to the medication. There is insufficient evidence to support the common practice of PRN medications for the management of acute agitation, and no data with which to inform clinical practice, such as which medicines and doses are helpful for specific populations or situations. Psychiatrists have no evidence-based medication interventions for acutely managing agitated outbursts in children and adolescents.

Percepción de niños y adolescentes sobre la calidad de vida en casos de trastorno por déficit de atención/hiperactividad con y sin tratamiento farmacológico y en controles / Children's and adolescents' perception of their quality of life in cases of attention deficit hyperactivity disorder with and without pharmacological treatment and in controls

Introducción. La calidad de vida relacionada con la salud percibida por niños y adolescentes es un factor importante para valorar los efectos de una intervención terapéutica. Objetivo. Analizar la calidad de vida comparando casos con trastorno por déficit de atención/hiperactividad (TDAH) tratados farmacológicamente con metilfenidato, casos no tratados y controles. Sujetos y métodos. Muestra de 228 participantes de 8-14 años. Muestreo consecutivo de casos de TDAH según los criterios del Manual diagnóstico y estadístico de los trastornos mentales, cuarta edición, y muestreo aleatorio de controles emparejados por sexo, edad y zona sociodemográfica. Evaluación de la calidad de vida mediante el KIDSCREEN-52 (versión niños y adolescentes). Para responder al objetivo se utilizó ANOVA con corrección de Bonferroni. Resultados. Observamos una correlación significativa moderada entre mayor intensidad de síntomas de TDAH y peor calidad de vida, excepto en el bienestar físico. Los casos de TDAH no tratados tienen significativamente peor calidad de vida que los controles en bienestar psíquico, autonomía, estado de ánimo, entorno escolar y aceptación social. Los casos de TDAH tratados observan similares resultados excepto en el entorno escolar y el bienestar psíquico, que no presentan diferencias significativas con los controles. Los casos de TDAH tratados por comparación con los de TDAH no tratados sólo presentan significativamente mejor calidad de vida en el entorno escolar. Conclusión. Los casos de TDAH presentan dimensiones del KIDSCREEN-52 con peor calidad de vida que los controles y los casos de TDAH tratados con metilfenidato sólo se diferencian significativamente de los no tratados porque presentan mejores resultados en el entorno escolar

Introduction. Health-related quality of life perceived by children and teenagers is important to assess the effects of therapeutic intervention. Aim: To analyze quality of life, comparing cases of attention deficit hyperactivity disorder (ADHD) treated with methylphenidate, untreated cases and controls. Subjects and methods: Sampling of 228 participants between 8 and 14 years-old. Consecutive sampling in ADHD according to DSM-IV criteria (ADHD Rating Scales IV) and random sampling of matched controls by sex and age. Evaluation of quality of life using KIDSCREEN-52 (children version). ANOVA with Bonferroni correction was used. Results: There is a moderate significant correlation between greater intensity of ADHD symptoms and worse quality of life, except in the dimension of physical well-being. Cases of untreated ADHD have significantly worse quality of life than controls on psychic well-being, mood, autonomy school environment and social acceptance. Cases of treated ADHD present similar results, except in the school environment and psychological well-being. The cases of ADHD treated only differ significantly from ADHD not treated in having a better school environment. Conclusions: The cases of ADHD present dimensions of KIDSCREEN-52 with worse quality of life than controls and the cases of ADHD treated with methylphenidate only differ significantly from those not treated in presenting better results in the school environment

Ablative stereotactic neurosurgery for irreducible neuroaggressive disorder in pediatric patients. / Neurocirugía estereotáctica ablativa para trastorno neuroagresivo irreductible en pediátricos.

INTRODUCTION AND OBJECTIVES: The irreducible neuroaggressive disorder (IND) is a well-described entity known to be associated with impulsive and aggressive behavior. While various studies have assessed available pharmacological and non-pharmacological treatment regimens, patients with IND continue to pose a major threat to themselves and society. While targeted stereotactic therapy for IND has gained traction in recent years, there is a paucity of information describing comparative effectiveness of different validated anatomic regions. In this paper, we discuss the surgical results for patients with IND following targeted lesional therapy with a special focus on selection criteria and operative methods. The objective is to analyze the efficacy and safety of the different described targets for this disorder in pediatric patients. MATERIALS AND METHODS: Eight pediatric patients met strict criteria for IND and were enrolled in this study. Electroencephalography (EEG), video electroencephalography (VEEG) and magnetic resonance imaging (MRI) were performed in all patients prior to surgery. Irreducible neuroagressive symptom was approached by lesional therapy based on most described targets for this disorder and assessed by The Overt Agressive Scale (OAS) pre-operatively and 6 months following surgery, using Wilcoxon test for statistical analysis. RESULTS AND CONCLUSIONS: The average patient age was 13 years 2 months. 7 of the 8 patients enrolled had intellectual disabilities, 1 patient suffered neurologic sequelae referable to Dandy Walker syndrome and 7 patients had no preoperative anatomical alterations. Following surgery, patients with IND noted improvement in their OAS. On average, the OAS improved by 39.29% (P=.0156), a figure similar in comparison to studies assessing treatment of IND in adult patients. The most satisfactory results were achieved in patients whose ablative therapy involved the Amygdala in their targets. There were no deaths or permanent neurological deficits attributable to procedure. To the author's knowledge, this is the largest series described in the literature for pediatric patients with IND treated with lesional stereotactic therapy.

Characteristics of Children Prescribed Antipsychotics: Analysis of Routinely Collected Data.

OBJECTIVE: Antipsychotics are licensed for psychosis and are also prescribed for behavior control. This study aims to examine characteristics and outcomes of children prescribed antipsychotics. METHODS: A cohort study using general practice and hospital records linked with education records for 1,488,936 children living in Wales between 1999 and 2015. The characteristics of the children who were prescribed antipsychotics are presented using descriptive statistics and outcomes such as respiratory illness, diabetes, and injury were analyzed using multilevel logistic regression and the prior event rate ratio (PERR). RESULTS: Children with intellectual difficulty/autism were more likely to be prescribed antipsychotics (2.8% have been prescribed an antipsychotic [75% with autism] compared with 0.15% of children without intellectual difficulty). Those with intellectual disabilities/autism were prescribed antipsychotics at a younger age and for a longer period. Antipsychotic use was associated with a higher rate of respiratory illness for all (PERR of hospital admission: 1.55 [95% CI: 1.51-1.598] or increase in rate of 2 per 100 per year in those treated), and for those with intellectual difficulty/autism, there was a higher rate of injury and hospitalized depression. However, among those without intellectual difficulty/autism, there were lower rates of depression (PERR: 0.55 [95% CI: 0.51-0.59]). CONCLUSIONS: This work shows real-world use of antipsychotics and provides information on the rate of possible adverse events in children treated. Antipsychotics are predominantly used for those with intellectual difficulty/autism rather than those with a psychotic diagnosis. There is evidence that rates of respiratory disease, epilepsy, and diabetes are also higher postantipsychotic use for all. In those with intellectual difficulty/autism, hospital-admitted depression and injury are higher postantipsychotic use. The use of antipsychotics for behavioral management is likely to have increased cost implications to the healthcare system.

Antipsychotic Prescribing and Safety Monitoring Practices in Children and Youth: A Population-Based Study in Alberta, Canada.

BACKGROUND AND OBJECTIVE: Antipsychotic medication use has steadily increased in Canada, with an expansion in the profile of users and the diagnoses for which they are used. The use of antipsychotics is associated with a number of adverse effects for which routine monitoring is recommended. The objectives of this study were to determine the most common diagnoses associated with antipsychotic use in children in Alberta, Canada and the proportion who receive recommended laboratory tests for adverse effects. METHODS: Data on dispensed antipsychotics, diagnoses, prescribers, and laboratory testing were obtained from provincial data sources. To assess the frequency of metabolic and hormonal laboratory baseline and/or follow-up testing, the sample was divided into an antipsychotic-naïve cohort and an antipsychotic non-naïve cohort. RESULTS: In 2014, 6916 children were dispensed at least one second- or third-generation antipsychotic. The most frequently dispensed antipsychotics were risperidone (3908 children), quetiapine (2140 children), and aripiprazole (1302 children). The majority of children prescribed risperidone were diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) or conduct disorder. Quetiapine was mainly prescribed for neurotic disorder or depression, while aripiprazole was prescribed most frequently for conduct disorder or neurotic disorders. Among antipsychotic-naïve patients, 17% had at least one laboratory test done at baseline, and 35% had at least one laboratory test done at follow-up. In the non-naïve patients, 42% had at least one follow-up laboratory test. Lipid and glucose testing were done in less than 5% of the naïve cohort at baseline, and in less than 15% at follow-up. In the non-naïve cohort, less than 22% received lipid or glucose testing during the year 2014. CONCLUSIONS: The majority of antipsychotic use in children in Alberta is off-label and associated with disruptive behavior disorders, depression, and anxiety disorders. The vast majority of children prescribed antipsychotic medications do not undergo recommended laboratory tests.

Comparison of Unlicensed and Off-Label Use of Antipsychotics Prescribed to Child and Adolescent Psychiatric Outpatients for Treatment of Mental and Behavioral Disorders with Different Guidelines: The China Food and Drug Administration Versus the FDA.

OBJECTIVES: This study aims to compare the prevalence of unlicensed and off-label use of antipsychotics among child and adolescent psychiatric outpatients with guidelines proposed by the China Food and Drug Administration (CFDA) and the U.S. Food and Drug Administration (FDA), and to identify factors associated with inconsistencies between the two regulations. METHODS: A retrospective analysis of 29,326 drug prescriptions for child and adolescent outpatients from the Affiliated Brain Hospital of Guangzhou Medical University was conducted. Antipsychotics were classified as "unlicensed" or "off-label use" according to the latest pediatric license information registered by the CFDA and the FDA or the package inserts of antipsychotics authorized by the CFDA or the FDA for the treatment of pediatric mental and behavioral disorders, respectively. Binary logistic regression analysis was performed to assess factors associated with inconsistencies between the two regulations. RESULTS: The total unlicensed use, according to the CFDA analysis, was higher than that found in the FDA analysis (74.14% vs. 22.04%, p < 0.001). However, the total off-label use, according to the FDA analysis, was higher than that found in the CFDA analysis (46.53% vs. 15.77%, p < 0.001). Antipsychotic drug classes, age group, number of diagnoses, and diagnosis of schizophrenia and schizotypal and delusional disorders were associated with inconsistent unlicensed use. Antipsychotic drug classes, age group, number of prescribed psychotropic drugs, gender, diagnosis of schizophrenia and schizotypal and delusional disorders, diagnosis of mood [affective] disorders, diagnosis of mental retardation, and diagnosis of psychological development disorders were associated with inconsistent off-label use. CONCLUSIONS: The difference in prevalence of total unlicensed and off-label use of antipsychotics between the two regulations was statistically significant. This inconsistency could be partly attributed to differences in pediatric license information and package inserts of antipsychotics. The results indicate a need for further clinical pediatric studies and better harmonization between agencies regarding antipsychotic used in pediatrics.

Five-Year-Old Boy With Behavioral Changes and Papilledema.

A 5-year-old boy had initial symptoms of behavioral changes, nausea, vomiting, headache, weight loss, and progressive vision failure. Brain MRI revealed abnormal signal intensity in both optic nerves, the optic chiasm, the right medial temporal lobe, and tissues surrounding the right supraclinoid internal carotid artery with associated leptomeningeal and spinal cord enhancement. After nondiagnostic dural and spinal arachnoid biopsies, a temporal lobe biopsy was diagnostic for a rare malignant peripheral nerve sheath tumor.