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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EIn light of the continuing controversy concerning the use and safety of psychiatric medications in children and adolescents, several researchers in the field of child psychiatry met to discuss recent findings concerning adverse events in this population.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Epsychopharmacology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Echild \u0026amp; adolescent psychiatry\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EIn light of the continuing controversy concerning the use and safety of psychiatric medications in children and adolescents, several researchers in the field of child psychiatry met to discuss recent findings concerning adverse events in this population.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EAssessing Safety Outcomes\u003C\/h2\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EAdverse event (AE) data in clinical trials of depression typically are collected using spontaneous reports that are given by patients in response to general questions (eg, \u201cHow have you been?\u201d \u201cWhat\u0027s been happening?\u201d). Graham Emslie, MD, University of Texas Southwestern, Dallas, TX, discussed the prospective systematic approach that was used in the TORDIA (Treatment of Resistant Depression in Adolescents) and TADS (Treatment for Adolescents with Depression Study) trials.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EBoth trials used spontaneous reports; however, during the TADS trial, AE data also were collected using several self and clinician reports (one patient form, five clinician forms and one summary form). The TORDIA study added the Side Effects Form for Children and Adolescents (SEFCA), as well as a weekly clinician form for monitoring clinically significant worsening of symptoms. The investigators also conducted weekly consensus calls to discuss AE reporting and weekly calls to patients to monitor safety. Prodromal symptoms that were associated with an increase in suicidality were monitored, and all reports of suicide attempts were reviewed against a common definition.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EIn both studies, the investigators noted that different methods for eliciting AEs produced different results, which were at times associated with the background of the individual who was taking the report or were the result of unclear definitions. Dr. Emslie said, \u201cMore refinement is needed in the collection of adverse event data, including improved prospective measures and clarification and consensus among study sites on these AE definitions. Adequate training on all of these measures is critical.\u201d\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EFurther reading: TADS [March J et al. \u003Cem\u003EJAMA\u003C\/em\u003E 2004; Emslie et al. \u003Cem\u003EJ Am Acad Child Adolesc Psychiatry\u003C\/em\u003E 2006; \u003Ca href=\u0022http:\/\/trialweb.dcri.duke.edu\/tads\/index.html\u0022\u003Ehttps:\/\/trialweb.dcri.duke.edu\/tads\/index.html\u003C\/a\u003E]. TORDIA [Brent et al. \u003Cem\u003EJAMA\u003C\/em\u003E 2008].\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-3\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EAdverse Effects of Antipsychotic Treatment of Early Onset Schizophrenia Spectrum Disorders\u003C\/h2\u003E\n         \u003Cp id=\u0022p-7\u0022\u003ELinmarie Sikich, MD, University of North Carolina, Chapel Hill, NC, presented unpublished data from the TEOSS (Treatment of Early Onset Schizophrenia Spectrum Disorders) study, a randomized, double-blind, 8-week trial that compared the safety and efficacy of once-daily doses of 3 antipsychotic treatments in youths aged 8\u201319 years with schizophrenia or schizoaffective disorder with active psychotic symptoms.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003ESafety was monitored at each visit using the following: systematically elicited adverse events, The Simpson Angus Extrapyramidal Scale, the Barnes Akathisia Scale, vital signs, skinfold thickness, and waist and hip circumference. Laboratory tests (CBC, SMA 20, leptin, insulin, C-peptide, HbA1c, free fatty acids, lipids, and prolactin) were conducted at Weeks 0, 4, 8, 24, 26, 52, or at termination. Patients also received an ECG and Abnormal Involuntary Movement Scale (AIMS) rating.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EApproximately 50% of 116 subjects who received study medication withdrew before the end of 8 weeks because of lack of efficacy or side effects. Serious adverse events (SAEs) during the acute phase included 7 hospitalizations for worsening psychosis, which often was associated with suicidal ideation and aggression toward others. One hospitalization for severe urinary retention (risperidone) was reported.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EOf the 54 subjects who entered the maintenance phase, 65% withdrew before the end of 12 months. One SAE occurred during the maintenance phase (hospitalization for dangerousness to others; risperidone). The primary reasons for withdrawal were lack of efficacy and side effects (primarily weight gain and akathisia).\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EA variety of AEs were seen during this study (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). Some were significant and varied by medication and class. Dr. Sikich concluded, \u201cWe know that side effects differ among the antipsychotic medications, but we still don\u0027t know how to weigh them in terms of what keeps individuals on their medications and what the long-term health consequences are. There is remaining work to do.\u201d\u003C\/p\u003E\n         \u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/10891\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/10891\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/10891\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-12\u0022 class=\u0022first-child\u0022\u003EAdverse Events in Acute Phase.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-4\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EStimulants and Risk of Vascular Events\u003C\/h2\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EThe American Heart Association has suggested that children and adolescents receive an ECG before starting stimulants and that those who are already on stimulants receive one if they have not already done so [Vetter VL et al. \u003Cem\u003ECirculation\u003C\/em\u003E 2008]. Mark Olfson, MD, Columbia University, New York, NY, reviewed some of the literature concerning possible relationships between stimulant use and cardiovascular disease.\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EMuch of the concern over the risk of stimulant-associated cardiovascular effects comes from the adult literature, which shows some evidence that small increases in systolic blood pressure (BP) over a long period of time are associated with an increased risk for stroke [Prospective Studies Collaboration. \u003Cem\u003ELancet\u003C\/em\u003E 2002], as well as myocardial infarction and total mortality. A similar connection also has been seen with heart rate and cardiovascular mortality [Palatin P et al. \u003Cem\u003EArch Int Med\u003C\/em\u003E 1999]. The concern is that these small changes, when seen in youth over many years, may be associated with morbidity.\u003C\/p\u003E\n         \u003Cp id=\u0022p-15\u0022\u003E\u201cWhile there are some data in youth that show statistically significant changes in diastolic BP and pulse over time [Findling RL et al. \u003Cem\u003EJ Am Acad Child Adolesc Psychiatry\u003C\/em\u003E 2001; Samuels JA et al. \u003Cem\u003EPediatr Nephrol\u003C\/em\u003E 2006], the question we need to ask as clinicians is, \u201cAre these changes clinically significant?\u201d said Dr. Olfson.\u003C\/p\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EWinterstein and colleagues recently published results from a retrospective cohort study that followed youths aged 3 to 20 years who were newly diagnosed with ADHD. Stimulant use was tracked as: current, former, or nonuse (time preceding the first stimulant claim, including follow-up of youth who were never exposed to stimulants). Study endpoints were cardiac death, first hospital admission for cardiac causes, or first emergency department visit for cardiac causes. Results show that during 124,932 person-years of observation (n=55,383), there were 73 deaths (5 due to cardiac causes, none of which occurred during stimulant use). The incidence of cardiac events that required hospitalization was small and similar to national background rates (27 youths hospitalized; 8 current use, 11 former use, 8 nonuse). Stimulants were associated with an increase in cardiac emergency department visits (1091 youths). Former use did not confer an additional risk when compared with nonuse [Winterstein AG et al. \u003Cem\u003EPediatrics\u003C\/em\u003E 2007].\u003C\/p\u003E\n         \u003Cp id=\u0022p-17\u0022\u003E\u201cWe really don\u0027t yet have the kind of evidence that one would need before reaching a firm conclusion of a causal association between stimulants and risk of cardiovascular events in youth,\u201d said Dr. Olfson, noting that the current evidence is cause for caution, not alarm.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2008 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/8\/3\/18.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzmdxq\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzmdxq\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}