RT Journal Article
T1 Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial.
A1 Coghill, David R
A1 Banaschewski, Tobias
A1 Lecendreux, Michel
A1 Zuddas, Alessandro
A1 Dittmann, Ralf W
A1 Hernández Otero, Isabel
A1 Civil, Richard
A1 Bloomfield, Ralph
A1 Squires, Liza A
K1 ADHD
K1 Lisdexamfetamine dimesylate
K1 Randomized controlled trial
K1 Central nervous system stimulants
K1 Maintenance of efficacy
K1 Conners’ parent rating scale
K1 Estimulantes del sistema nervioso central
K1 Conducta del adolescente
K1 Trastorno por déficit de atención con hiperactividad
K1 Anfetaminas
K1 Resultado del tratamiento
K1 Ensayo clínico controlado aleatorio
K1 Dextroanfetamina
K1 Niño
K1 Adolescente
AB 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).
PB Springer Verlag
SN 1018-8827
YR 2014
FD 2014-02
LK http://hdl.handle.net/10668/1552
UL http://hdl.handle.net/10668/1552
LA en
NO Coghill 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):61-8
NO Journal Article;
DS RISalud
RD Apr 18, 2025