| Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study. | |
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MedLine Citation:
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PMID: 16322134 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Modafinil, which is structurally and pharmacologically different from other agents that are used for the treatment of children with attention-deficit/hyperactivity disorder (ADHD), selectively activates the cortex and has low potential for abuse. Initial studies of the use of modafinil to treat ADHD showed significant improvements in the core symptoms of the disorder, namely inattention, hyperactivity, and impulsivity. This study evaluated a new formulation of modafinil (modafinil film-coated tablets) in children and adolescents with ADHD. METHODS: This 9-week, multicenter, randomized, double-blind, placebo-controlled, flexible-dose study evaluated the film-coated tablet formulation of modafinil, which was titrated to an optimal dose on the basis of efficacy and tolerability (range: 170-425 mg once daily). Efficacy was assessed by clinicians who completed the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) based on interviews with teachers (School Version) and parents (Home Version) and the Clinical Global Impression of Improvement scale. Safety evaluation was based on assessments of adverse event reports, laboratory tests, vital signs, and body weight. RESULTS: A total of 248 subjects were randomly assigned in a 2:1 ratio, and 246 were treated with modafinil (n = 164) or placebo (n = 82). Treatment groups were comparable with respect to demographics and baseline characteristics. Intention-to-treat analysis (ITT) showed that compared with placebo, treatment with modafinil significantly improved the core symptoms of ADHD as shown by greater reductions in the ADHD-RS-IV School Version total scores from baseline to final visit (mean change [SD]: -15.0 [11.8] vs -7.3 [9.7]) (effect size: 0.69; 95% confidence interval: 0.57-0.82). Significant improvements were observed with modafinil treatment on the ADHD-RS-IV School Version at week 1, with improvements maintained throughout the study. Similar differences in symptom improvements were observed on the ADHD-RS-IV Home Version between modafinil-treated and placebo-treated patients. Treatment with modafinil also significantly reduced subscale scores for inattention and hyperactivity-impulsivity on both School and Home Versions compared with placebo. At the final visit, 48% of modafinil-treated patients were rated as "much" or "very much" improved in overall clinical condition compared with 17% of placebo-treated patients (Clinical Global Impression of Improvement). Most adverse events were mild to moderate in severity, and the majority resolved during treatment. The most commonly reported adverse events in the modafinil group were insomnia (29%), headache (20%), and decreased appetite (16%). Three percent of modafinil-treated patients and 4% of placebo-treated patients discontinued treatment because of adverse events. CONCLUSIONS: Modafinil film-coated tablets significantly improved ADHD symptoms at school and home as evaluated by clinicians, teachers, and parents. Treatment with once-daily modafinil was generally well tolerated, with few discontinuations as a result of adverse events. |
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Authors:
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Joseph Biederman; James M Swanson; Sharon B Wigal; Christopher J Kratochvil; Samuel W Boellner; Craig Q Earl; John Jiang; L Greenhill |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Pediatrics Volume: 116 ISSN: 1098-4275 ISO Abbreviation: Pediatrics Publication Date: 2005 Dec |
Date Detail:
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Created Date: 2005-12-02 Completed Date: 2005-12-22 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0376422 Medline TA: Pediatrics Country: United States |
Other Details:
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Languages: eng Pagination: e777-84 Citation Subset: AIM; IM |
Affiliation:
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Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston, MA 02114, USA. jbiederman@partners.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Attention Deficit Disorder with Hyperactivity / drug therapy* Benzhydryl Compounds / administration & dosage, therapeutic use* Central Nervous System Stimulants / administration & dosage, therapeutic use* Child Double-Blind Method Female Humans Male Tablets |
| Chemical | |
Reg. No./Substance:
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0/Benzhydryl Compounds; 0/Central Nervous System Stimulants; 0/Tablets; 68693-11-8/modafinil |
| Comments/Corrections | |
Comment In:
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Evid Based Ment Health. 2006 Aug;9(3):68
[PMID:
16868187
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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