Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial
Copyright policy )Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial
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).
- Heidelberg University Germany
- University of Cagliari Italy
- University of Dundee United Kingdom
- University of Melbourne Australia
- Central Institute of Mental Health Germany
Male, Parents, Dextroamphetamine, Adolescent, Medical Subject Headings::Publication Characteristics::Study Characteristics::Clinical Trial::Randomized Controlled Trial, 610, Drug Administration Schedule, Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans, Double-Blind Method, Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amines::Ethylamines::Phenethylamines::Amphetamines::Amphetamine::Dextroamphetamine, Humans, Prodrugs, Pediatrics, Perinatology, and Child Health, Lisdexamfetamine Dimesylate, Child, Medical Subject Headings::Named Groups::Persons::Age Groups::Adolescent, Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Stimulants, Medical Subject Headings::Psychiatry and Psychology::Mental Disorders::Mental Disorders Diagnosed in Childhood::Attention Deficit and Disruptive Behavior Disorders::Attention Deficit Disorder with Hyperactivity, Dose-Response Relationship, Drug, Medical Subject Headings::Named Groups::Persons::Age Groups::Child, Original Contribution, Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amines::Ethylamines::Phenethylamines::Amphetamines, Medical Subject Headings::Psychiatry and Psychology::Behavior and Behavior Mechanisms::Behavior::Adolescent Behavior, Psychiatry and Mental health, Treatment Outcome, Attention Deficit Disorder with Hyperactivity, Methylphenidate, Medical Subject Headings::Health Care::Health Services Administration::Quality of Health Care::Outcome and Process Assessment (Health Care)::Outcome Assessment (Health Care)::Treatment Outcome, Central Nervous System Stimulants, Female
Male, Parents, Dextroamphetamine, Adolescent, Medical Subject Headings::Publication Characteristics::Study Characteristics::Clinical Trial::Randomized Controlled Trial, 610, Drug Administration Schedule, Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans, Double-Blind Method, Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amines::Ethylamines::Phenethylamines::Amphetamines::Amphetamine::Dextroamphetamine, Humans, Prodrugs, Pediatrics, Perinatology, and Child Health, Lisdexamfetamine Dimesylate, Child, Medical Subject Headings::Named Groups::Persons::Age Groups::Adolescent, Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Stimulants, Medical Subject Headings::Psychiatry and Psychology::Mental Disorders::Mental Disorders Diagnosed in Childhood::Attention Deficit and Disruptive Behavior Disorders::Attention Deficit Disorder with Hyperactivity, Dose-Response Relationship, Drug, Medical Subject Headings::Named Groups::Persons::Age Groups::Child, Original Contribution, Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amines::Ethylamines::Phenethylamines::Amphetamines, Medical Subject Headings::Psychiatry and Psychology::Behavior and Behavior Mechanisms::Behavior::Adolescent Behavior, Psychiatry and Mental health, Treatment Outcome, Attention Deficit Disorder with Hyperactivity, Methylphenidate, Medical Subject Headings::Health Care::Health Services Administration::Quality of Health Care::Outcome and Process Assessment (Health Care)::Outcome Assessment (Health Care)::Treatment Outcome, Central Nervous System Stimulants, Female
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