Coghill, David RBanaschewski, TobiasLecendreux, MichelZuddas, AlessandroDittmann, Ralf WHernández Otero, IsabelCivil, RichardBloomfield, RalphSquires, Liza A2014-03-262014-03-262014-02Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, et al. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2014 ; 23(2):61-81018-8827http://hdl.handle.net/10668/1552Journal Article;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).enADHDLisdexamfetamine dimesylateRandomized controlled trialCentral nervous system stimulantsMaintenance of efficacyConners’ parent rating scaleEstimulantes del sistema nervioso centralConducta del adolescenteTrastorno por déficit de atención con hiperactividadAnfetaminasResultado del tratamientoEnsayo clínico controlado aleatorioDextroanfetaminaNiñoAdolescenteMedical Subject Headings::Psychiatry and Psychology::Mental Disorders::Mental Disorders Diagnosed in Childhood::Attention Deficit and Disruptive Behavior Disorders::Attention Deficit Disorder with HyperactivityMedical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amines::Ethylamines::Phenethylamines::AmphetaminesMedical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System StimulantsMedical Subject Headings::Named Groups::Persons::Age Groups::ChildMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amines::Ethylamines::Phenethylamines::Amphetamines::Amphetamine::DextroamphetamineMedical Subject Headings::Psychiatry and Psychology::Behavior and Behavior Mechanisms::Behavior::Adolescent BehaviorMedical Subject Headings::Health Care::Health Services Administration::Quality of Health Care::Outcome and Process Assessment (Health Care)::Outcome Assessment (Health Care)::Treatment OutcomeMedical Subject Headings::Publication Characteristics::Study Characteristics::Clinical Trial::Randomized Controlled TrialMedical Subject Headings::Named Groups::Persons::Age Groups::Adolescentresearch article23708466open access10.1007/s00787-013-0421-y1435-165XPMC3918120