{"corpus_id":11443010,"paper_sha":"5e7e9e803e89ac51565a874e7eabbd041839626c","doi":"10.1007/s00787-013-0421-y","arxiv_id":null,"pmid":23708466,"pmcid":"3918120","mag_id":2072871224,"dblp_id":null,"acl_id":null,"title":"Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial","year":2013,"publication_date":"2013-05-25","venue":"European Child and Adolescent Psychiatry","journal":{"name":"European Child & Adolescent Psychiatry","pages":"61 - 68","volume":"23"},"journal_issn":null,"journal_title":null,"publication_types":["JournalArticle"],"pubmed_pub_types":["Journal Article","Randomized Controlled Trial","Research Support, Non-U.S. Gov't"],"s2_fields_of_study":["Medicine","Psychology"],"reference_count":30,"citation_count":35,"influential_citation_count":3,"is_open_access":true,"arxiv_categories":null,"arxiv_license":null,"arxiv_journal_ref":null,"mesh_headings":[{"d":"Adolescent","mj":false,"ui":"D000293"},{"d":"Attention Deficit Disorder with Hyperactivity","mj":false,"qs":[{"q":"drug therapy","mj":true,"ui":"Q000188"},{"q":"psychology","mj":false,"ui":"Q000523"}],"ui":"D001289"},{"d":"Central Nervous System Stimulants","mj":false,"qs":[{"q":"administration & dosage","mj":false,"ui":"Q000008"},{"q":"adverse effects","mj":false,"ui":"Q000009"},{"q":"therapeutic use","mj":true,"ui":"Q000627"}],"ui":"D000697"},{"d":"Child","mj":false,"ui":"D002648"},{"d":"Dextroamphetamine","mj":false,"qs":[{"q":"administration & dosage","mj":false,"ui":"Q000008"},{"q":"adverse effects","mj":false,"ui":"Q000009"},{"q":"therapeutic use","mj":true,"ui":"Q000627"}],"ui":"D003913"},{"d":"Dose-Response Relationship, Drug","mj":false,"ui":"D004305"},{"d":"Double-Blind Method","mj":false,"ui":"D004311"},{"d":"Drug Administration Schedule","mj":false,"ui":"D004334"},{"d":"Female","mj":false,"ui":"D005260"},{"d":"Humans","mj":false,"ui":"D006801"},{"d":"Lisdexamfetamine Dimesylate","mj":false,"ui":"D000069478"},{"d":"Male","mj":false,"ui":"D008297"},{"d":"Methylphenidate","mj":false,"qs":[{"q":"administration & dosage","mj":false,"ui":"Q000008"},{"q":"adverse effects","mj":false,"ui":"Q000009"},{"q":"therapeutic use","mj":false,"ui":"Q000627"}],"ui":"D008774"},{"d":"Parents","mj":false,"ui":"D010290"},{"d":"Prodrugs","mj":false,"ui":"D011355"},{"d":"Treatment Outcome","mj":false,"ui":"D016896"}],"chemicals":[{"n":"Central Nervous System Stimulants","ui":"D000697","reg":"0"},{"n":"Prodrugs","ui":"D011355","reg":"0"},{"n":"Methylphenidate","ui":"D008774","reg":"207ZZ9QZ49"},{"n":"Lisdexamfetamine Dimesylate","ui":"D000069478","reg":"SJT761GEGS"},{"n":"Dextroamphetamine","ui":"D003913","reg":"TZ47U051FI"}],"comments_corrections":null,"source_flags":5,"s2_open_access_pdf_url":"https://link.springer.com/content/pdf/10.1007/s00787-013-0421-y.pdf","s2_open_access_landing_url":"https://www.semanticscholar.org/paper/5e7e9e803e89ac51565a874e7eabbd041839626c","s2_open_access_license":"CCBY","s2_open_access_status":"HYBRID","pmc_open_access_pdf_url":null,"pmc_open_access_landing_url":null,"pmc_open_access_license":null,"pmc_open_access_status":null,"unpaywall_open_access_pdf_url":null,"unpaywall_open_access_landing_url":null,"unpaywall_open_access_license":null,"unpaywall_open_access_status":null,"abstract":"Lisdexamfetamine dimesylate (LDX) is a long-acting, prodrug stimulant therapy for patients with attention-deficit/hyperactivity disorder (ADHD). This randomized placebo-controlled trial of an optimized daily dose of LDX (30, 50 or 70 mg) was conducted in children and adolescents (aged 6–17 years) with ADHD. To evaluate the efficacy of LDX throughout the day, symptoms and behaviors of ADHD were evaluated using an abbreviated version of the Conners’ Parent Rating Scale-Revised (CPRS-R) at 1000, 1400 and 1800 hours following early morning dosing (0700 hours). Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference treatment, but the study was not designed to support a statistical comparison between LDX and OROS-MPH. The full analysis set comprised 317 patients (LDX, n = 104; placebo, n = 106; OROS-MPH, n = 107). At baseline, CPRS-R total scores were similar across treatment groups. At endpoint, differences (active treatment − placebo) in least squares (LS) mean change from baseline CPRS-R total scores were statistically significant (P < 0.001) throughout the day for LDX (effect sizes: 1000 hours, 1.42; 1400 hours, 1.41; 1800 hours, 1.30) and OROS-MPH (effect sizes: 1000 hours, 1.04; 1400 hours, 0.98; 1800 hours, 0.92). Differences in LS mean change from baseline to endpoint were statistically significant (P < 0.001) for both active treatments in all four subscales of the CPRS-R (ADHD index, oppositional, hyperactivity and cognitive). In conclusion, improvements relative to placebo in ADHD-related symptoms and behaviors in children and adolescents receiving a single morning dose of LDX or OROS-MPH were maintained throughout the day and were ongoing at the last measurement in the evening (1800 hours).","claims":[{"public_id":"cl_0fa4d4ac3013bbd64c06f182196aee12","status":"active","text":"A single morning dose of lisdexamfetamine dimesylate produced statistically significant improvements relative to placebo in ADHD-related symptoms and behaviors throughout the day in children and adolescents with ADHD.","confidence":0.98,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_0fa4d4ac3013bbd64c06f182196aee12"},{"public_id":"cl_35679f6f236c8e877a0e92121ca5e65c","status":"active","text":"Improvements relative to placebo were also statistically significant for lisdexamfetamine 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statistically significant improvements relative to placebo throughout the day, but the trial was not designed to support a statistical comparison with lisdexamfetamine dimesylate.","confidence":0.93,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_cd6b0fe3173b040391554e40b81bfefb"}],"concepts":[{"public_id":"co_0e36d27df5ad1662b2cd4c5981c62e92","status":"active","name":"optimized daily dose","description":"A daily dose selected from specified dose levels for the trial treatment.","types":["dose regimen"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_0e36d27df5ad1662b2cd4c5981c62e92"},{"public_id":"co_1681da56184813cb0ec86036892dc5d6","status":"active","name":"Conners’ Parent Rating 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