Methodological issues in designing a multisite trial of risperidone in children and adolescents with autism
To describe the methodological challenges and decisions made in developing a multisite, controlled study of risperidone in children and adolescents with autism. Review the design considerations for clinical trials in children with autistic disorder accompanied by severe tantrums, aggressive and/or s...
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| Veröffentlicht in: | Journal of child and adolescent psychopharmacology 2001-12, Vol.11 (4), p.377-388 |
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| creator | Scahill, L McCracken, J McDougle, C J Aman, M Arnold, L E Tierney, E Cronin, P Davies, M Ghuman, J Gonzalez, N Koenig, K Lindsay, R Martin, A McGough, J Posey, D J Swiezy, N Volkmar, F Ritz, L Vitiello, B |
| description | To describe the methodological challenges and decisions made in developing a multisite, controlled study of risperidone in children and adolescents with autism.
Review the design considerations for clinical trials in children with autistic disorder accompanied by severe tantrums, aggressive and/or self-injurious behaviors. These design considerations include the definition of inclusion criteria that are relevant to clinical practice and matching study design to the goal of evaluating short- and long-term effects. Additional ethical and scientific issues concern the length of trial and sample size.
We undertook a short-term, placebo-controlled study to evaluate the efficacy and safety of risperidone in children and adolescents with autistic disorder. This trial design was followed by an extended open-label maintenance on risperidone to confirm durability of treatment effects and to monitor safety. Finally, a placebo-controlled discontinuation study tested the need for continuous treatment.
In the absence of standard pharmacological treatment for children with autistic disorder, a placebo-controlled study remains the most appropriate method of testing efficacy and safety. The clinical relevance of this study is enhanced by the addition of an extended maintenance phase followed by a placebo discontinuation. |
| doi_str_mv | 10.1089/104454601317261555 |
| format | Article |
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Review the design considerations for clinical trials in children with autistic disorder accompanied by severe tantrums, aggressive and/or self-injurious behaviors. These design considerations include the definition of inclusion criteria that are relevant to clinical practice and matching study design to the goal of evaluating short- and long-term effects. Additional ethical and scientific issues concern the length of trial and sample size.
We undertook a short-term, placebo-controlled study to evaluate the efficacy and safety of risperidone in children and adolescents with autistic disorder. This trial design was followed by an extended open-label maintenance on risperidone to confirm durability of treatment effects and to monitor safety. Finally, a placebo-controlled discontinuation study tested the need for continuous treatment.
In the absence of standard pharmacological treatment for children with autistic disorder, a placebo-controlled study remains the most appropriate method of testing efficacy and safety. The clinical relevance of this study is enhanced by the addition of an extended maintenance phase followed by a placebo discontinuation.</description><identifier>ISSN: 1044-5463</identifier><identifier>EISSN: 1557-8992</identifier><identifier>DOI: 10.1089/104454601317261555</identifier><identifier>PMID: 11838820</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Adolescent ; Age Factors ; Antipsychotic Agents - adverse effects ; Antipsychotic Agents - therapeutic use ; Autism ; Autistic Disorder - drug therapy ; Child ; Child, Preschool ; Controlled Clinical Trials as Topic ; Double-Blind Method ; Female ; Humans ; Male ; Multicenter Studies as Topic ; Planning Techniques ; Research Design ; Risperidone - adverse effects ; Risperidone - therapeutic use ; Time Factors</subject><ispartof>Journal of child and adolescent psychopharmacology, 2001-12, Vol.11 (4), p.377-388</ispartof><rights>Copyright Mary Ann Liebert Inc. Dec 2001</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c326t-4a50f5c0e22218fdb86aabbb63b3c59c7eadb12eb61838a3e936fdb14f7c8f53</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3029,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11838820$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Scahill, L</creatorcontrib><creatorcontrib>McCracken, J</creatorcontrib><creatorcontrib>McDougle, C J</creatorcontrib><creatorcontrib>Aman, M</creatorcontrib><creatorcontrib>Arnold, L E</creatorcontrib><creatorcontrib>Tierney, E</creatorcontrib><creatorcontrib>Cronin, P</creatorcontrib><creatorcontrib>Davies, M</creatorcontrib><creatorcontrib>Ghuman, J</creatorcontrib><creatorcontrib>Gonzalez, N</creatorcontrib><creatorcontrib>Koenig, K</creatorcontrib><creatorcontrib>Lindsay, R</creatorcontrib><creatorcontrib>Martin, A</creatorcontrib><creatorcontrib>McGough, J</creatorcontrib><creatorcontrib>Posey, D J</creatorcontrib><creatorcontrib>Swiezy, N</creatorcontrib><creatorcontrib>Volkmar, F</creatorcontrib><creatorcontrib>Ritz, L</creatorcontrib><creatorcontrib>Vitiello, B</creatorcontrib><title>Methodological issues in designing a multisite trial of risperidone in children and adolescents with autism</title><title>Journal of child and adolescent psychopharmacology</title><addtitle>J Child Adolesc Psychopharmacol</addtitle><description>To describe the methodological challenges and decisions made in developing a multisite, controlled study of risperidone in children and adolescents with autism.
Review the design considerations for clinical trials in children with autistic disorder accompanied by severe tantrums, aggressive and/or self-injurious behaviors. These design considerations include the definition of inclusion criteria that are relevant to clinical practice and matching study design to the goal of evaluating short- and long-term effects. Additional ethical and scientific issues concern the length of trial and sample size.
We undertook a short-term, placebo-controlled study to evaluate the efficacy and safety of risperidone in children and adolescents with autistic disorder. This trial design was followed by an extended open-label maintenance on risperidone to confirm durability of treatment effects and to monitor safety. Finally, a placebo-controlled discontinuation study tested the need for continuous treatment.
In the absence of standard pharmacological treatment for children with autistic disorder, a placebo-controlled study remains the most appropriate method of testing efficacy and safety. The clinical relevance of this study is enhanced by the addition of an extended maintenance phase followed by a placebo discontinuation.</description><subject>Adolescent</subject><subject>Age Factors</subject><subject>Antipsychotic Agents - adverse effects</subject><subject>Antipsychotic Agents - therapeutic use</subject><subject>Autism</subject><subject>Autistic Disorder - drug therapy</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Controlled Clinical Trials as Topic</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Multicenter Studies as Topic</subject><subject>Planning Techniques</subject><subject>Research Design</subject><subject>Risperidone - adverse effects</subject><subject>Risperidone - therapeutic use</subject><subject>Time Factors</subject><issn>1044-5463</issn><issn>1557-8992</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNplkMtOwzAURC0EolD4ARbIYh_wI3acJap4SUVsuo_8SuuS2MV2hPh7XLUSC1ZzF2fmagaAG4zuMRLtA0Z1zWqOMMUN4ZgxdgIuijSVaFtyWu4CVIWgM3CZ0hYVkiN-DmYYCyoEQRfg893mTTBhCGun5QBdSpNN0HlobHJr7_waSjhOQ3bJZQtzdIUKPYwu7Wx0Jni7p_XGDSZaD6U3UJY8m7T1OcFvlzdQTsU-XoGzXg7JXh91DlbPT6vFa7X8eHlbPC4rTQnPVS0Z6plGlhCCRW-U4FIqpThVVLNWN1YahYlVfN9CUttSXihc940WPaNzcHeI3cXwVcrkbhum6MvHjqCatXVDRYHIAdIxpBRt3-2iG2X86TDq9ut2_9ctpttj8qRGa_4sxznpL9sudvY</recordid><startdate>20011201</startdate><enddate>20011201</enddate><creator>Scahill, L</creator><creator>McCracken, J</creator><creator>McDougle, C J</creator><creator>Aman, M</creator><creator>Arnold, L E</creator><creator>Tierney, E</creator><creator>Cronin, P</creator><creator>Davies, M</creator><creator>Ghuman, J</creator><creator>Gonzalez, N</creator><creator>Koenig, K</creator><creator>Lindsay, R</creator><creator>Martin, A</creator><creator>McGough, J</creator><creator>Posey, D J</creator><creator>Swiezy, N</creator><creator>Volkmar, F</creator><creator>Ritz, L</creator><creator>Vitiello, B</creator><general>Mary Ann Liebert, Inc</general><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>3V.</scope><scope>7QG</scope><scope>7RV</scope><scope>7TK</scope><scope>7TM</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope></search><sort><creationdate>20011201</creationdate><title>Methodological issues in designing a multisite trial of risperidone in children and adolescents with autism</title><author>Scahill, L ; McCracken, J ; McDougle, C J ; Aman, M ; Arnold, L E ; Tierney, E ; Cronin, P ; Davies, M ; Ghuman, J ; Gonzalez, N ; Koenig, K ; Lindsay, R ; Martin, A ; McGough, J ; Posey, D J ; Swiezy, N ; Volkmar, F ; Ritz, L ; Vitiello, B</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c326t-4a50f5c0e22218fdb86aabbb63b3c59c7eadb12eb61838a3e936fdb14f7c8f53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Adolescent</topic><topic>Age Factors</topic><topic>Antipsychotic Agents - 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Review the design considerations for clinical trials in children with autistic disorder accompanied by severe tantrums, aggressive and/or self-injurious behaviors. These design considerations include the definition of inclusion criteria that are relevant to clinical practice and matching study design to the goal of evaluating short- and long-term effects. Additional ethical and scientific issues concern the length of trial and sample size.
We undertook a short-term, placebo-controlled study to evaluate the efficacy and safety of risperidone in children and adolescents with autistic disorder. This trial design was followed by an extended open-label maintenance on risperidone to confirm durability of treatment effects and to monitor safety. Finally, a placebo-controlled discontinuation study tested the need for continuous treatment.
In the absence of standard pharmacological treatment for children with autistic disorder, a placebo-controlled study remains the most appropriate method of testing efficacy and safety. The clinical relevance of this study is enhanced by the addition of an extended maintenance phase followed by a placebo discontinuation.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>11838820</pmid><doi>10.1089/104454601317261555</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of child and adolescent psychopharmacology, 2001-12, Vol.11 (4), p.377-388 |
| issn | 1044-5463 1557-8992 |
| language | eng |
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| source | Mary Ann Liebert Online Subscription; MEDLINE |
| subjects | Adolescent Age Factors Antipsychotic Agents - adverse effects Antipsychotic Agents - therapeutic use Autism Autistic Disorder - drug therapy Child Child, Preschool Controlled Clinical Trials as Topic Double-Blind Method Female Humans Male Multicenter Studies as Topic Planning Techniques Research Design Risperidone - adverse effects Risperidone - therapeutic use Time Factors |
| title | Methodological issues in designing a multisite trial of risperidone in children and adolescents with autism |
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