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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)
[article]
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
in Journal of Child Psychology and Psychiatry > 57-6 (June 2016) . - p.717-728[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 Object interest in autism spectrum disorder: A treatment comparison / Andrea MCDUFFIE in Autism, 16-4 (July 2012)
[article]
Titre : Object interest in autism spectrum disorder: A treatment comparison Type de document : Texte imprimé et/ou numérique Auteurs : Andrea MCDUFFIE, Auteur ; Rebecca G. LIEBERMAN, Auteur ; Paul J. YODER, Auteur Année de publication : 2012 Article en page(s) : p.398-405 Langues : Anglais (eng) Mots-clés : autism intervention object interest play randomised RPMT Index. décimale : PER Périodiques Résumé : A randomized control trial comparing two social communication treatments for children with autism spectrum disorder examined the effect of treatment on object interest. Thirty-two children, 18–60 months, were randomly assigned to the Picture Exchange Communication System (PECS) or Responsive Education and Prelinguistic Milieu Teaching (RPMT) condition. Assessment of object interest was conducted in an unstructured play session with different toys, activities, adult, and location than experienced in treatment. Results indicated children in the RPMT condition showed greater increases in object interest as compared to children in the PECS condition. Because child characteristics such as interest in objects may influence response to interventions using object play as contexts for treatment, it is important to improve our understanding of whether intervention can affect object interest. En ligne : http://dx.doi.org/10.1177/1362361309360983 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=178
in Autism > 16-4 (July 2012) . - p.398-405[article] Object interest in autism spectrum disorder: A treatment comparison [Texte imprimé et/ou numérique] / Andrea MCDUFFIE, Auteur ; Rebecca G. LIEBERMAN, Auteur ; Paul J. YODER, Auteur . - 2012 . - p.398-405.
Langues : Anglais (eng)
in Autism > 16-4 (July 2012) . - p.398-405
Mots-clés : autism intervention object interest play randomised RPMT Index. décimale : PER Périodiques Résumé : A randomized control trial comparing two social communication treatments for children with autism spectrum disorder examined the effect of treatment on object interest. Thirty-two children, 18–60 months, were randomly assigned to the Picture Exchange Communication System (PECS) or Responsive Education and Prelinguistic Milieu Teaching (RPMT) condition. Assessment of object interest was conducted in an unstructured play session with different toys, activities, adult, and location than experienced in treatment. Results indicated children in the RPMT condition showed greater increases in object interest as compared to children in the PECS condition. Because child characteristics such as interest in objects may influence response to interventions using object play as contexts for treatment, it is important to improve our understanding of whether intervention can affect object interest. En ligne : http://dx.doi.org/10.1177/1362361309360983 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=178