کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
10299175 539694 2013 11 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder
ترجمه فارسی عنوان
مطالعۀ اروپائی، تصادفی، فاز 3 مطالعه داروی لیسکسمایفتامین در کودکان و نوجوانان مبتلا به اختلال کمبود توجه / بیش فعالی
کلمات کلیدی
نوجوانان اختلال کمبود توجه با بیش فعالی، محرک های سیستم عصبی مرکزی، کودک، لیسدسامفاتامین دیمسیلات، پیش دارو
موضوعات مرتبط
علوم زیستی و بیوفناوری علم عصب شناسی روانپزشکی بیولوژیکی
چکیده انگلیسی
This study evaluated the efficacy and safety of lisdexamfetamine dimesylate (LDX) compared with placebo in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) in Europe. Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference arm. Patients (6-17 years old) with a baseline ADHD Rating Scale version IV (ADHD-RS-IV) total score ≥28 were randomized (1:1:1) to dose-optimized LDX (30, 50, or 70 mg/day), OROS-MPH (18, 36, or 54 mg/day) or placebo for 7 weeks. Primary and key secondary efficacy measures were the investigator-rated ADHD-RS-IV and the Clinical Global Impressions-Improvement (CGI-I) rating, respectively. Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms, and vital signs. Of 336 patients randomized, 196 completed the study. The difference between LDX and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was −18.6 (95% confidence interval [CI]: −21.5 to −15.7) (p<0.001; effect size, 1.80). The difference between OROS-MPH and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was −13.0 (95% CI: −15.9 to −10.2) (p<0.001; effect size, 1.26). The proportions (95% CI) of patients showing improvement (CGI-I of 1 or 2) at endpoint were 78% (70-86), 14% (8-21), and 61% (51-70) for LDX, placebo, and OROS-MPH. The most common TEAEs for LDX were decreased appetite, headache, and insomnia. Mean changes in vital signs were modest and consistent with the known profile of LDX. LDX was effective and generally well tolerated in children and adolescents with ADHD.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Neuropsychopharmacology - Volume 23, Issue 10, October 2013, Pages 1208-1218
نویسندگان
, , , , , , , , , , ,