Extended-release guanfacine hydrochloride in 6–17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study / Jeffrey H. NEWCORN in Journal of Child Psychology and Psychiatry, 57-6 (June 2016)  

Public ISBD [article]  inJournal of Child Psychology and Psychiatry > 57-6 (June 2016) . - p.717-728 Titre : Extended-release guanfacine hydrochloride in 6–17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study Type de document : Texte imprimé et/ou numérique Auteurs : Jeffrey H. NEWCORN, Auteur ; Valerie HARPIN, Auteur ; Michael HUSS, Auteur ; Andrew LYNE, Auteur ; Vanja SIKIRICA, Auteur ; Mats JOHNSON, Auteur ; Josep Antoni RAMOS-QUIROGA, Auteur ; Judy VAN STRALEN, Auteur ; Benoit DUTRAY, Auteur ; Sasha SRECKOVIC, Auteur ; Ralph BLOOMFIELD, Auteur ; Brigitte ROBERTSON, Auteur Article en page(s) : p.717-728 Langues : Anglais (eng) Mots-clés : Long term  efficacy  randomised  withdrawal  attention-deficit/hyperactivity disorder  guanfacine Index. décimale : PER Périodiques Résumé : Background Extended-release guanfacine hydrochloride (GXR), a selective ?2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder (ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6–17 years) with ADHD received open-label GXR (1–7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase (RWP). The primary endpoint was the percentage of treatment failure (?50% increase in ADHD Rating Scale version IV total score and ?2-point increase in Clinical Global Impression-Severity compared with RWP baseline, at two consecutive visits). The key secondary endpoint was time to treatment failure (TTF). Trial registration ClinicalTrials.gov identifier NCT01081145; EudraCT 2009-018161-12. Results A total of 528 participants enrolled; 316 (59.8%) entered the RWP. Treatment failure occurred in 49.3% of the GXR and 64.9% of the placebo group (p = 0.006). TTF was significantly longer in GXR versus placebo (p = 0.003). GXR was well tolerated. Conclusions Guanfacine hydrochloride demonstrated long-term maintenance of efficacy compared with placebo in children/adolescents with ADHD. Implications of the placebo substitution design and findings with different ADHD medications are discussed. En ligne : http://dx.doi.org/10.1111/jcpp.12492 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=289 [article] Extended-release guanfacine hydrochloride in 6–17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study [Texte imprimé et/ou numérique] / Jeffrey H. NEWCORN, Auteur ; Valerie HARPIN, Auteur ; Michael HUSS, Auteur ; Andrew LYNE, Auteur ; Vanja SIKIRICA, Auteur ; Mats JOHNSON, Auteur ; Josep Antoni RAMOS-QUIROGA, Auteur ; Judy VAN STRALEN, Auteur ; Benoit DUTRAY, Auteur ; Sasha SRECKOVIC, Auteur ; Ralph BLOOMFIELD, Auteur ; Brigitte ROBERTSON, Auteur . - p.717-728. Langues : Anglais (eng) in Journal of Child Psychology and Psychiatry > 57-6 (June 2016) . - p.717-728 Mots-clés : Long term  efficacy  randomised  withdrawal  attention-deficit/hyperactivity disorder  guanfacine Index. décimale : PER Périodiques Résumé : Background Extended-release guanfacine hydrochloride (GXR), a selective ?2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder (ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6–17 years) with ADHD received open-label GXR (1–7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase (RWP). The primary endpoint was the percentage of treatment failure (?50% increase in ADHD Rating Scale version IV total score and ?2-point increase in Clinical Global Impression-Severity compared with RWP baseline, at two consecutive visits). The key secondary endpoint was time to treatment failure (TTF). Trial registration ClinicalTrials.gov identifier NCT01081145; EudraCT 2009-018161-12. Results A total of 528 participants enrolled; 316 (59.8%) entered the RWP. Treatment failure occurred in 49.3% of the GXR and 64.9% of the placebo group (p = 0.006). TTF was significantly longer in GXR versus placebo (p = 0.003). GXR was well tolerated. Conclusions Guanfacine hydrochloride demonstrated long-term maintenance of efficacy compared with placebo in children/adolescents with ADHD. Implications of the placebo substitution design and findings with different ADHD medications are discussed. En ligne : http://dx.doi.org/10.1111/jcpp.12492 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=289

Omega 3/6 fatty acids for reading in children: a randomized, double-blind, placebo-controlled trial in 9-year-old mainstream schoolchildren in Sweden / Mats JOHNSON in Journal of Child Psychology and Psychiatry, 58-1 (January 2017)  

Public ISBD [article]  inJournal of Child Psychology and Psychiatry > 58-1 (January 2017) . - p.83-93 Titre : Omega 3/6 fatty acids for reading in children: a randomized, double-blind, placebo-controlled trial in 9-year-old mainstream schoolchildren in Sweden Type de document : Texte imprimé et/ou numérique Auteurs : Mats JOHNSON, Auteur ; Gunnar FRANSSON, Auteur ; Sven ÖSTLUND, Auteur ; Björn ARESKOUG, Auteur ; Christopher GILLBERG, Auteur Article en page(s) : p.83-93 Langues : Anglais (eng) Mots-clés : Omega 3/6  Logos test  reading  mainstream schoolchildren  attention problems Index. décimale : PER Périodiques Résumé : Background Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. Methods We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active treatment for all subjects. Mainstream schoolchildren aged 9–10 years were randomized 1:1 to receive three Omega 3/6 capsules twice daily or identical placebo. Assessments were made at baseline, 3 months, and 6 months. The primary outcome measure was the Logos test battery for evaluating reading abilities. The trial is registered with ClinicalTrials.gov, number NCT02557477. Results The study enrolled 154 children (active n = 78; placebo n = 76), of whom 122 completed the first 3 months (active n = 64; placebo n = 58) and 105 completed the whole study (active/active n = 55; placebo/active n = 50). Outcomes were assessed by per protocol (PP) and intention-to-treat (ITT) analyses. Active treatment was superior to placebo at 3 months for improvement in phonologic decoding time (PP active/placebo difference ?0.16; 95% CI ?0.03, ?0.29; effect size (ES) .44; p = .005; and ITT ES .37; p = .036), in visual analysis time (PP active/placebo difference ?0.19; 95% CI ?0.05, ?0.33; ES .49; p = .013; and ITT ES .40; p = .01), and for boys in phonologic decoding time (PP ?0.22; 95% CI ?0.03, ?0.41; ES .62; p = .004). Children with ADHD-RS scores above the median showed treatment benefits in visual analysis time (PP ES .8, p = .009), reading speed per word (PP ES .61, p = .008), and phonologic decoding time per word (PP ES .85, p = .006). Adverse events were rare and mild, mainly stomach pain/diarrhea (active n = 9, placebo n = 2). Conclusions Compared with placebo, 3 months of Omega 3/6 treatment improved reading ability – specifically the clinically relevant ‘phonologic decoding time’ and ‘visual analysis time’ – in mainstream schoolchildren. In particular, children with attention problems showed treatment benefits. En ligne : http://dx.doi.org/10.1111/jcpp.12614 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=298 [article] Omega 3/6 fatty acids for reading in children: a randomized, double-blind, placebo-controlled trial in 9-year-old mainstream schoolchildren in Sweden [Texte imprimé et/ou numérique] / Mats JOHNSON, Auteur ; Gunnar FRANSSON, Auteur ; Sven ÖSTLUND, Auteur ; Björn ARESKOUG, Auteur ; Christopher GILLBERG, Auteur . - p.83-93. Langues : Anglais (eng) in Journal of Child Psychology and Psychiatry > 58-1 (January 2017) . - p.83-93 Mots-clés : Omega 3/6  Logos test  reading  mainstream schoolchildren  attention problems Index. décimale : PER Périodiques Résumé : Background Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. Methods We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active treatment for all subjects. Mainstream schoolchildren aged 9–10 years were randomized 1:1 to receive three Omega 3/6 capsules twice daily or identical placebo. Assessments were made at baseline, 3 months, and 6 months. The primary outcome measure was the Logos test battery for evaluating reading abilities. The trial is registered with ClinicalTrials.gov, number NCT02557477. Results The study enrolled 154 children (active n = 78; placebo n = 76), of whom 122 completed the first 3 months (active n = 64; placebo n = 58) and 105 completed the whole study (active/active n = 55; placebo/active n = 50). Outcomes were assessed by per protocol (PP) and intention-to-treat (ITT) analyses. Active treatment was superior to placebo at 3 months for improvement in phonologic decoding time (PP active/placebo difference ?0.16; 95% CI ?0.03, ?0.29; effect size (ES) .44; p = .005; and ITT ES .37; p = .036), in visual analysis time (PP active/placebo difference ?0.19; 95% CI ?0.05, ?0.33; ES .49; p = .013; and ITT ES .40; p = .01), and for boys in phonologic decoding time (PP ?0.22; 95% CI ?0.03, ?0.41; ES .62; p = .004). Children with ADHD-RS scores above the median showed treatment benefits in visual analysis time (PP ES .8, p = .009), reading speed per word (PP ES .61, p = .008), and phonologic decoding time per word (PP ES .85, p = .006). Adverse events were rare and mild, mainly stomach pain/diarrhea (active n = 9, placebo n = 2). Conclusions Compared with placebo, 3 months of Omega 3/6 treatment improved reading ability – specifically the clinically relevant ‘phonologic decoding time’ and ‘visual analysis time’ – in mainstream schoolchildren. In particular, children with attention problems showed treatment benefits. En ligne : http://dx.doi.org/10.1111/jcpp.12614 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=298

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