Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials
Children with autism spectrum disorder are prescribed various medications to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity and prevent contamination of clinical endpoints. However, this choice may com...
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| Veröffentlicht in: | Autism : the international journal of research and practice 2023-05, Vol.27 (4), p.952-966 |
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| creator | Shurtz, Logan Schwartz, Chloe DiStefano, Charlotte McPartland, James C Levin, April R Dawson, Geraldine Kleinhans, Natalia M Faja, Susan Webb, Sara J Shic, Frederick Naples, Adam J Seow, Helen Bernier, Raphael A Chawarska, Katarzyna Sugar, Catherine A Dziura, James Senturk, Damla Santhosh, Megha Jeste, Shafali S |
| description | Children with autism spectrum disorder are prescribed various medications to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity and prevent contamination of clinical endpoints. However, this choice may compromise the representativeness of the sample. In a recent study designed to identify biomarkers and endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, providing the opportunity to examine characteristics of psychotropic medication use and guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the study and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Our findings suggest that exclusion of children taking concomitant psychotropic medications could limit the representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options.
Lay abstract
Children with autism spectrum disorder are prescribed a variety of medications that affect the central nervous system (psychotropic medications) to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity of the sample and prevent contamination of biomarkers or clinical endpoints. However, this choice may significantly diminish the clinical representativeness of the sample. In a recent multisite study designed to identify biomarkers and behavioral endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, thus providing a unique opportunity to examine characteristics of psychotropic medication use in a research cohort and to guide future decisions on medication-related inclusion criteria. The aims of the current analysis were |
| doi_str_mv | 10.1177/13623613221121425 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9995606</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><ericid>EJ1374443</ericid><sage_id>10.1177_13623613221121425</sage_id><sourcerecordid>2800556350</sourcerecordid><originalsourceid>FETCH-LOGICAL-c488t-2c6862f643f11e5aad868f6cd39735581a577e3f4df663669a1cb760c599d5023</originalsourceid><addsrcrecordid>eNp1kUtv1TAQhS0EoqXwA1iALHXTTYrHryQskMql0KJKbMrach271yWxL7ZT1D0_HF-lXF5iNZbPN3NmdBB6DuQYoG1fAZOUSWCUAlDgVDxA-8AlNC0h4mF9V73ZAnvoSc43pP5yAY_RHpOkkx0R--j7KgYTJ190KHiygze6-BjwnC32AZu1H4dkA_7myxrrufg84byxpqR5woPPMQ02vcbvdNHYpTjhsrb4ZOHe-jjp9MWmjKtLRYuvTS4mvBp9qE4jvkxej_kpeuRqsc_u6wH6_P70cnXWXHz6cL46uWgM77rSUCM7SZ3kzAFYofVQj3DSDKxvmRAdaNG2ljk-OCmZlL0Gc9VKYkTfD4JQdoDeLHM381W91dhQkh7VJvm6552K2qs_leDX6jreqr7vhSSyDji6H5Di19nmoiafjR1HHWycs6It0I4LIrdeh3-hN3FOoZ6naFeDEJIJUilYKJNizsm63TJA1DZj9U_Gtefl71fsOn6GWoEXC2CTNzv59COwlnPOqn686Flf219r_d_xB-bjubQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2800556350</pqid></control><display><type>article</type><title>Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials</title><source>MEDLINE</source><source>Applied Social Sciences Index & Abstracts (ASSIA)</source><source>SAGE Complete A-Z List</source><creator>Shurtz, Logan ; Schwartz, Chloe ; DiStefano, Charlotte ; McPartland, James C ; Levin, April R ; Dawson, Geraldine ; Kleinhans, Natalia M ; Faja, Susan ; Webb, Sara J ; Shic, Frederick ; Naples, Adam J ; Seow, Helen ; Bernier, Raphael A ; Chawarska, Katarzyna ; Sugar, Catherine A ; Dziura, James ; Senturk, Damla ; Santhosh, Megha ; Jeste, Shafali S</creator><creatorcontrib>Shurtz, Logan ; Schwartz, Chloe ; DiStefano, Charlotte ; McPartland, James C ; Levin, April R ; Dawson, Geraldine ; Kleinhans, Natalia M ; Faja, Susan ; Webb, Sara J ; Shic, Frederick ; Naples, Adam J ; Seow, Helen ; Bernier, Raphael A ; Chawarska, Katarzyna ; Sugar, Catherine A ; Dziura, James ; Senturk, Damla ; Santhosh, Megha ; Jeste, Shafali S</creatorcontrib><description>Children with autism spectrum disorder are prescribed various medications to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity and prevent contamination of clinical endpoints. However, this choice may compromise the representativeness of the sample. In a recent study designed to identify biomarkers and endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, providing the opportunity to examine characteristics of psychotropic medication use and guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the study and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Our findings suggest that exclusion of children taking concomitant psychotropic medications could limit the representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options.
Lay abstract
Children with autism spectrum disorder are prescribed a variety of medications that affect the central nervous system (psychotropic medications) to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity of the sample and prevent contamination of biomarkers or clinical endpoints. However, this choice may significantly diminish the clinical representativeness of the sample. In a recent multisite study designed to identify biomarkers and behavioral endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, thus providing a unique opportunity to examine characteristics of psychotropic medication use in a research cohort and to guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the ABC-CT and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half of these children. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Descriptive analysis showed that children taking antipsychotics displayed a trend toward greater overall impairment. Our findings suggest that exclusion of children taking concomitant psychotropic medications in trials could limit the clinical representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options.</description><identifier>ISSN: 1362-3613</identifier><identifier>EISSN: 1461-7005</identifier><identifier>DOI: 10.1177/13623613221121425</identifier><identifier>PMID: 36086805</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Age ; Antipsychotic Agents - therapeutic use ; Antipsychotics ; Autism Spectrum Disorder - drug therapy ; Autism Spectrum Disorder - epidemiology ; Autism Spectrum Disorders ; Autistic children ; Autistic Disorder ; Behavior ; Behavior Problems ; Behavior rating scales ; Biological markers ; Biomarkers ; Central nervous system ; Child ; Child Behavior ; Children ; Clinical research ; Clinical trials ; Consortia ; Contamination ; Drug Therapy ; Humans ; Hyperactivity ; Incidence ; Individual Characteristics ; Melatonin ; Nervous system ; Original ; Personality Traits ; Polypharmacy ; Preadolescents ; Prescription drugs ; Psychotropic drugs ; Psychotropic Drugs - therapeutic use ; Representativeness ; Research Methodology ; Serotonin reuptake inhibitors ; Stimulants</subject><ispartof>Autism : the international journal of research and practice, 2023-05, Vol.27 (4), p.952-966</ispartof><rights>The Author(s) 2022</rights><rights>The Author(s) 2022 2022 The National Autistic Society, SAGE Publications</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c488t-2c6862f643f11e5aad868f6cd39735581a577e3f4df663669a1cb760c599d5023</citedby><cites>FETCH-LOGICAL-c488t-2c6862f643f11e5aad868f6cd39735581a577e3f4df663669a1cb760c599d5023</cites><orcidid>0000-0001-6876-3643 ; 0000-0003-4669-0388</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/13623613221121425$$EPDF$$P50$$Gsage$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/13623613221121425$$EHTML$$P50$$Gsage$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,21818,27923,27924,30998,43620,43621</link.rule.ids><backlink>$$Uhttp://eric.ed.gov/ERICWebPortal/detail?accno=EJ1374443$$DView record in ERIC$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36086805$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shurtz, Logan</creatorcontrib><creatorcontrib>Schwartz, Chloe</creatorcontrib><creatorcontrib>DiStefano, Charlotte</creatorcontrib><creatorcontrib>McPartland, James C</creatorcontrib><creatorcontrib>Levin, April R</creatorcontrib><creatorcontrib>Dawson, Geraldine</creatorcontrib><creatorcontrib>Kleinhans, Natalia M</creatorcontrib><creatorcontrib>Faja, Susan</creatorcontrib><creatorcontrib>Webb, Sara J</creatorcontrib><creatorcontrib>Shic, Frederick</creatorcontrib><creatorcontrib>Naples, Adam J</creatorcontrib><creatorcontrib>Seow, Helen</creatorcontrib><creatorcontrib>Bernier, Raphael A</creatorcontrib><creatorcontrib>Chawarska, Katarzyna</creatorcontrib><creatorcontrib>Sugar, Catherine A</creatorcontrib><creatorcontrib>Dziura, James</creatorcontrib><creatorcontrib>Senturk, Damla</creatorcontrib><creatorcontrib>Santhosh, Megha</creatorcontrib><creatorcontrib>Jeste, Shafali S</creatorcontrib><title>Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials</title><title>Autism : the international journal of research and practice</title><addtitle>Autism</addtitle><description>Children with autism spectrum disorder are prescribed various medications to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity and prevent contamination of clinical endpoints. However, this choice may compromise the representativeness of the sample. In a recent study designed to identify biomarkers and endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, providing the opportunity to examine characteristics of psychotropic medication use and guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the study and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Our findings suggest that exclusion of children taking concomitant psychotropic medications could limit the representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options.
Lay abstract
Children with autism spectrum disorder are prescribed a variety of medications that affect the central nervous system (psychotropic medications) to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity of the sample and prevent contamination of biomarkers or clinical endpoints. However, this choice may significantly diminish the clinical representativeness of the sample. In a recent multisite study designed to identify biomarkers and behavioral endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, thus providing a unique opportunity to examine characteristics of psychotropic medication use in a research cohort and to guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the ABC-CT and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half of these children. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Descriptive analysis showed that children taking antipsychotics displayed a trend toward greater overall impairment. Our findings suggest that exclusion of children taking concomitant psychotropic medications in trials could limit the clinical representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options.</description><subject>Age</subject><subject>Antipsychotic Agents - therapeutic use</subject><subject>Antipsychotics</subject><subject>Autism Spectrum Disorder - drug therapy</subject><subject>Autism Spectrum Disorder - epidemiology</subject><subject>Autism Spectrum Disorders</subject><subject>Autistic children</subject><subject>Autistic Disorder</subject><subject>Behavior</subject><subject>Behavior Problems</subject><subject>Behavior rating scales</subject><subject>Biological markers</subject><subject>Biomarkers</subject><subject>Central nervous system</subject><subject>Child</subject><subject>Child Behavior</subject><subject>Children</subject><subject>Clinical research</subject><subject>Clinical trials</subject><subject>Consortia</subject><subject>Contamination</subject><subject>Drug Therapy</subject><subject>Humans</subject><subject>Hyperactivity</subject><subject>Incidence</subject><subject>Individual Characteristics</subject><subject>Melatonin</subject><subject>Nervous system</subject><subject>Original</subject><subject>Personality Traits</subject><subject>Polypharmacy</subject><subject>Preadolescents</subject><subject>Prescription drugs</subject><subject>Psychotropic drugs</subject><subject>Psychotropic Drugs - therapeutic use</subject><subject>Representativeness</subject><subject>Research Methodology</subject><subject>Serotonin reuptake inhibitors</subject><subject>Stimulants</subject><issn>1362-3613</issn><issn>1461-7005</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>AFRWT</sourceid><sourceid>EIF</sourceid><sourceid>7QJ</sourceid><recordid>eNp1kUtv1TAQhS0EoqXwA1iALHXTTYrHryQskMql0KJKbMrach271yWxL7ZT1D0_HF-lXF5iNZbPN3NmdBB6DuQYoG1fAZOUSWCUAlDgVDxA-8AlNC0h4mF9V73ZAnvoSc43pP5yAY_RHpOkkx0R--j7KgYTJ190KHiygze6-BjwnC32AZu1H4dkA_7myxrrufg84byxpqR5woPPMQ02vcbvdNHYpTjhsrb4ZOHe-jjp9MWmjKtLRYuvTS4mvBp9qE4jvkxej_kpeuRqsc_u6wH6_P70cnXWXHz6cL46uWgM77rSUCM7SZ3kzAFYofVQj3DSDKxvmRAdaNG2ljk-OCmZlL0Gc9VKYkTfD4JQdoDeLHM381W91dhQkh7VJvm6552K2qs_leDX6jreqr7vhSSyDji6H5Di19nmoiafjR1HHWycs6It0I4LIrdeh3-hN3FOoZ6naFeDEJIJUilYKJNizsm63TJA1DZj9U_Gtefl71fsOn6GWoEXC2CTNzv59COwlnPOqn686Flf219r_d_xB-bjubQ</recordid><startdate>20230501</startdate><enddate>20230501</enddate><creator>Shurtz, Logan</creator><creator>Schwartz, Chloe</creator><creator>DiStefano, Charlotte</creator><creator>McPartland, James C</creator><creator>Levin, April R</creator><creator>Dawson, Geraldine</creator><creator>Kleinhans, Natalia M</creator><creator>Faja, Susan</creator><creator>Webb, Sara J</creator><creator>Shic, Frederick</creator><creator>Naples, Adam J</creator><creator>Seow, Helen</creator><creator>Bernier, Raphael A</creator><creator>Chawarska, Katarzyna</creator><creator>Sugar, Catherine A</creator><creator>Dziura, James</creator><creator>Senturk, Damla</creator><creator>Santhosh, Megha</creator><creator>Jeste, Shafali S</creator><general>SAGE Publications</general><general>SAGE PUBLICATIONS, INC</general><scope>AFRWT</scope><scope>7SW</scope><scope>BJH</scope><scope>BNH</scope><scope>BNI</scope><scope>BNJ</scope><scope>BNO</scope><scope>ERI</scope><scope>PET</scope><scope>REK</scope><scope>WWN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QJ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6876-3643</orcidid><orcidid>https://orcid.org/0000-0003-4669-0388</orcidid></search><sort><creationdate>20230501</creationdate><title>Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials</title><author>Shurtz, Logan ; Schwartz, Chloe ; DiStefano, Charlotte ; McPartland, James C ; Levin, April R ; Dawson, Geraldine ; Kleinhans, Natalia M ; Faja, Susan ; Webb, Sara J ; Shic, Frederick ; Naples, Adam J ; Seow, Helen ; Bernier, Raphael A ; Chawarska, Katarzyna ; Sugar, Catherine A ; Dziura, James ; Senturk, Damla ; Santhosh, Megha ; Jeste, Shafali S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c488t-2c6862f643f11e5aad868f6cd39735581a577e3f4df663669a1cb760c599d5023</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Age</topic><topic>Antipsychotic Agents - therapeutic use</topic><topic>Antipsychotics</topic><topic>Autism Spectrum Disorder - drug therapy</topic><topic>Autism Spectrum Disorder - epidemiology</topic><topic>Autism Spectrum Disorders</topic><topic>Autistic children</topic><topic>Autistic Disorder</topic><topic>Behavior</topic><topic>Behavior Problems</topic><topic>Behavior rating scales</topic><topic>Biological markers</topic><topic>Biomarkers</topic><topic>Central nervous system</topic><topic>Child</topic><topic>Child Behavior</topic><topic>Children</topic><topic>Clinical research</topic><topic>Clinical trials</topic><topic>Consortia</topic><topic>Contamination</topic><topic>Drug Therapy</topic><topic>Humans</topic><topic>Hyperactivity</topic><topic>Incidence</topic><topic>Individual Characteristics</topic><topic>Melatonin</topic><topic>Nervous system</topic><topic>Original</topic><topic>Personality Traits</topic><topic>Polypharmacy</topic><topic>Preadolescents</topic><topic>Prescription drugs</topic><topic>Psychotropic drugs</topic><topic>Psychotropic Drugs - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Autism : the international journal of research and practice</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shurtz, Logan</au><au>Schwartz, Chloe</au><au>DiStefano, Charlotte</au><au>McPartland, James C</au><au>Levin, April R</au><au>Dawson, Geraldine</au><au>Kleinhans, Natalia M</au><au>Faja, Susan</au><au>Webb, Sara J</au><au>Shic, Frederick</au><au>Naples, Adam J</au><au>Seow, Helen</au><au>Bernier, Raphael A</au><au>Chawarska, Katarzyna</au><au>Sugar, Catherine A</au><au>Dziura, James</au><au>Senturk, Damla</au><au>Santhosh, Megha</au><au>Jeste, Shafali S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><ericid>EJ1374443</ericid><atitle>Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials</atitle><jtitle>Autism : the international journal of research and practice</jtitle><addtitle>Autism</addtitle><date>2023-05-01</date><risdate>2023</risdate><volume>27</volume><issue>4</issue><spage>952</spage><epage>966</epage><pages>952-966</pages><issn>1362-3613</issn><eissn>1461-7005</eissn><abstract>Children with autism spectrum disorder are prescribed various medications to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity and prevent contamination of clinical endpoints. However, this choice may compromise the representativeness of the sample. In a recent study designed to identify biomarkers and endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, providing the opportunity to examine characteristics of psychotropic medication use and guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the study and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Our findings suggest that exclusion of children taking concomitant psychotropic medications could limit the representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options.
Lay abstract
Children with autism spectrum disorder are prescribed a variety of medications that affect the central nervous system (psychotropic medications) to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity of the sample and prevent contamination of biomarkers or clinical endpoints. However, this choice may significantly diminish the clinical representativeness of the sample. In a recent multisite study designed to identify biomarkers and behavioral endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, thus providing a unique opportunity to examine characteristics of psychotropic medication use in a research cohort and to guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the ABC-CT and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half of these children. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Descriptive analysis showed that children taking antipsychotics displayed a trend toward greater overall impairment. Our findings suggest that exclusion of children taking concomitant psychotropic medications in trials could limit the clinical representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>36086805</pmid><doi>10.1177/13623613221121425</doi><tpages>15</tpages><orcidid>https://orcid.org/0000-0001-6876-3643</orcidid><orcidid>https://orcid.org/0000-0003-4669-0388</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1362-3613 |
| ispartof | Autism : the international journal of research and practice, 2023-05, Vol.27 (4), p.952-966 |
| issn | 1362-3613 1461-7005 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9995606 |
| source | MEDLINE; Applied Social Sciences Index & Abstracts (ASSIA); SAGE Complete A-Z List |
| subjects | Age Antipsychotic Agents - therapeutic use Antipsychotics Autism Spectrum Disorder - drug therapy Autism Spectrum Disorder - epidemiology Autism Spectrum Disorders Autistic children Autistic Disorder Behavior Behavior Problems Behavior rating scales Biological markers Biomarkers Central nervous system Child Child Behavior Children Clinical research Clinical trials Consortia Contamination Drug Therapy Humans Hyperactivity Incidence Individual Characteristics Melatonin Nervous system Original Personality Traits Polypharmacy Preadolescents Prescription drugs Psychotropic drugs Psychotropic Drugs - therapeutic use Representativeness Research Methodology Serotonin reuptake inhibitors Stimulants |
| title | Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials |
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