Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) / V. CRUTEL in Journal of Autism and Developmental Disorders, 51-8 (August 2021)  

Public ISBD [article]  inJournal of Autism and Developmental Disorders > 51-8 (August 2021) . - p.2959-2972 Titre : Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) Type de document : Texte imprimé et/ou numérique Auteurs : V. CRUTEL, Auteur ; E. LAMBERT, Auteur ; P. F. PENELAUD, Auteur ; C. ALBARRÁN SEVERO, Auteur ; J. FUENTES, Auteur ; A. ROSIER, Auteur ; A. HERVAS, Auteur ; S. MARRET, Auteur ; G. OLIVEIRA, Auteur ; Mara PARELLADA, Auteur ; S. KYAGA, Auteur ; S. GOUTTEFANGEAS, Auteur ; M. BERTRAND, Auteur ; D. RAVEL, Auteur ; B. FALISSARD, Auteur Article en page(s) : p.2959-2972 Langues : Anglais (eng) Mots-clés : Adolescent  Autism Spectrum Disorder/drug therapy  Bumetanide/administration & dosage/therapeutic use  Child  Child, Preschool  Double-Blind Method  Humans  Male  Research Design  Social Behavior  Treatment Outcome  Autism spectrum disorder  Bumetanide  Pediatrics  Randomized controlled trial  for Actelion, Allergan, Almirall, Astellas, AstraZeneca, Bayer, Biotronik, BMS,  Boehringer Ingelheim, Daiichi- Sankyo, Eli Lilly, Genzyme, Gilead, Grunenthal, GSK,  HRA, Janssen, Lundbeck, MSD, Novartis, Otsuka, Pierre Fabre, Roche, Sanofi, Servier,  Stallergene, UCB, ViiV. JF has received research support from Servier and  AIMS-2-Trials project ID 777394. DR is an employee of Neurochlore. GO, SM, AR, AH,  and MP report no conflict of interest. Index. décimale : PER Périodiques Résumé : There are currently no approved pharmacological treatments to improve social reciprocity and limit repetitive and rigid behaviors in autism spectrum disorder (ASD). We describe the design of two Phase III studies evaluating the efficacy/safety of bumetanide oral liquid formulation in ASD. These are international, multicenter, randomized, double-blind, placebo-controlled studies in children and adolescents with ASD aged 7 to 17 years (n?=?200; study 1), or younger children with ASD aged 2 to 6 years (n?=?200; study 2). The primary endpoint of each is change in Childhood Autism Rating Scale 2 total raw score after 6 months. These studies could contribute to the first pharmacological treatment to improve social reciprocity and limit repetitive and rigid behaviors in children and adolescents with ASD. En ligne : http://dx.doi.org/10.1007/s10803-020-04709-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=453 [article] Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) [Texte imprimé et/ou numérique] / V. CRUTEL, Auteur ; E. LAMBERT, Auteur ; P. F. PENELAUD, Auteur ; C. ALBARRÁN SEVERO, Auteur ; J. FUENTES, Auteur ; A. ROSIER, Auteur ; A. HERVAS, Auteur ; S. MARRET, Auteur ; G. OLIVEIRA, Auteur ; Mara PARELLADA, Auteur ; S. KYAGA, Auteur ; S. GOUTTEFANGEAS, Auteur ; M. BERTRAND, Auteur ; D. RAVEL, Auteur ; B. FALISSARD, Auteur . - p.2959-2972. Langues : Anglais (eng) in Journal of Autism and Developmental Disorders > 51-8 (August 2021) . - p.2959-2972 Mots-clés : Adolescent  Autism Spectrum Disorder/drug therapy  Bumetanide/administration & dosage/therapeutic use  Child  Child, Preschool  Double-Blind Method  Humans  Male  Research Design  Social Behavior  Treatment Outcome  Autism spectrum disorder  Bumetanide  Pediatrics  Randomized controlled trial  for Actelion, Allergan, Almirall, Astellas, AstraZeneca, Bayer, Biotronik, BMS,  Boehringer Ingelheim, Daiichi- Sankyo, Eli Lilly, Genzyme, Gilead, Grunenthal, GSK,  HRA, Janssen, Lundbeck, MSD, Novartis, Otsuka, Pierre Fabre, Roche, Sanofi, Servier,  Stallergene, UCB, ViiV. JF has received research support from Servier and  AIMS-2-Trials project ID 777394. DR is an employee of Neurochlore. GO, SM, AR, AH,  and MP report no conflict of interest. Index. décimale : PER Périodiques Résumé : There are currently no approved pharmacological treatments to improve social reciprocity and limit repetitive and rigid behaviors in autism spectrum disorder (ASD). We describe the design of two Phase III studies evaluating the efficacy/safety of bumetanide oral liquid formulation in ASD. These are international, multicenter, randomized, double-blind, placebo-controlled studies in children and adolescents with ASD aged 7 to 17 years (n?=?200; study 1), or younger children with ASD aged 2 to 6 years (n?=?200; study 2). The primary endpoint of each is change in Childhood Autism Rating Scale 2 total raw score after 6 months. These studies could contribute to the first pharmacological treatment to improve social reciprocity and limit repetitive and rigid behaviors in children and adolescents with ASD. En ligne : http://dx.doi.org/10.1007/s10803-020-04709-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=453

Correction to: Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) / V. CRUTEL in Journal of Autism and Developmental Disorders, 51-8 (August 2021)  

Public ISBD [article]  inJournal of Autism and Developmental Disorders > 51-8 (August 2021) . - p.2973 Titre : Correction to: Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) Type de document : Texte imprimé et/ou numérique Auteurs : V. CRUTEL, Auteur ; E. LAMBERT, Auteur ; P. F. PENELAUD, Auteur ; C. ALBARRÁN SEVERO, Auteur ; J. FUENTES, Auteur ; A. ROSIER, Auteur ; A. HERVAS, Auteur ; S. MARRET, Auteur ; G. OLIVEIRA, Auteur ; Mara PARELLADA, Auteur ; S. KYAGA, Auteur ; S. GOUTTEFANGEAS, Auteur ; M. BERTRAND, Auteur ; D. RAVEL, Auteur ; B. FALISSARD, Auteur Article en page(s) : p.2973 Langues : Anglais (eng) Index. décimale : PER Périodiques En ligne : http://dx.doi.org/10.1007/s10803-020-04822-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=453 [article] Correction to: Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) [Texte imprimé et/ou numérique] / V. CRUTEL, Auteur ; E. LAMBERT, Auteur ; P. F. PENELAUD, Auteur ; C. ALBARRÁN SEVERO, Auteur ; J. FUENTES, Auteur ; A. ROSIER, Auteur ; A. HERVAS, Auteur ; S. MARRET, Auteur ; G. OLIVEIRA, Auteur ; Mara PARELLADA, Auteur ; S. KYAGA, Auteur ; S. GOUTTEFANGEAS, Auteur ; M. BERTRAND, Auteur ; D. RAVEL, Auteur ; B. FALISSARD, Auteur . - p.2973. Langues : Anglais (eng) in Journal of Autism and Developmental Disorders > 51-8 (August 2021) . - p.2973 Index. décimale : PER Périodiques En ligne : http://dx.doi.org/10.1007/s10803-020-04822-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=453

Sex differences in psychiatric comorbidity and clinical presentation in youths with conduct disorder / K. KONRAD in Journal of Child Psychology and Psychiatry, 63-2 (February 2022)  

Public ISBD [article]  inJournal of Child Psychology and Psychiatry > 63-2 (February 2022) . - p.218-228 Titre : Sex differences in psychiatric comorbidity and clinical presentation in youths with conduct disorder Type de document : Texte imprimé et/ou numérique Auteurs : K. KONRAD, Auteur ; G. KOHLS, Auteur ; S. BAUMANN, Auteur ; A. BERNHARD, Auteur ; A. MARTINELLI, Auteur ; Katharina ACKERMANN, Auteur ; A. SMARAGDI, Auteur ; K. GONZALEZ-MADRUGA, Auteur ; A. WELLS, Auteur ; J. C. ROGERS, Auteur ; R. PAULI, Auteur ; R. CLANTON, Auteur ; R. BAKER, Auteur ; L. KERSTEN, Auteur ; M. PRÄTZLICH, Auteur ; H. OLDENHOF, Auteur ; L. JANSEN, Auteur ; A. KLEEVEN, Auteur ; Aitana BIGORRA, Auteur ; A. HERVAS, Auteur ; I. KEREXETA-LIZEAGA, Auteur ; E. SESMA-PARDO, Auteur ; M. ANGEL GONZALEZ-TORRES, Auteur ; R. SIKLÓSI, Auteur ; R. DOCHNAL, Auteur ; Z. KALOGERAKIS, Auteur ; M. PIRLYMPOU, Auteur ; L. PAPADAKOS, Auteur ; H. CORNWELL, Auteur ; W. SCHARKE, Auteur ; Dimitris DIKEOS, Auteur ; A. FERNÁNDEZ-RIVAS, Auteur ; A. POPMA, Auteur ; C. STADLER, Auteur ; B. HERPERTZ-DAHLMANN, Auteur ; Stephane A. DE BRITO, Auteur ; G. FAIRCHILD, Auteur ; C. M. FREITAG, Auteur Article en page(s) : p.218-228 Langues : Anglais (eng) Mots-clés : Conduct disorder  callous-unemotional traits  psychiatric comorbidity  sex differences Index. décimale : PER Périodiques Résumé : BACKGROUND: Conduct disorder (CD) rarely occurs alone but is typically accompanied by comorbid psychiatric disorders, which complicates the clinical presentation and treatment of affected youths. The aim of this study was to investigate sex differences in comorbidity pattern in CD and to systematically explore the 'gender paradox' and 'delayed-onset pathway' hypotheses of female CD. METHODS: As part of the FemNAT-CD multisite study, semistructured clinical interviews and rating scales were used to perform a comprehensive phenotypic characterization of 454 girls and 295 boys with CD (9-18?years), compared to 864 sex- and age-matched typically developing controls. RESULTS: Girls with CD exhibited higher rates of current major depression, anxiety disorders, post-traumatic stress disorder and borderline personality disorder, whereas boys with CD had higher rates of current attention-deficit/hyperactivity disorder. In line with the 'gender paradox' hypothesis, relative to boys, girls with CD showed significantly more lifetime psychiatric comorbidities (incl. Alcohol Use Disorder), which were accompanied by more severe CD symptoms. Female and male youths with CD also differed significantly in their CD symptom profiles and distribution of age-of-onset subtypes of CD (i.e. fewer girls with childhood-onset CD). In line with the 'delayed-onset pathway' hypothesis, girls with adolescent-onset CD showed similar levels of dimensional psychopathology like boys with childhood-onset CD, while boys with adolescent-onset CD had the lowest levels of internalizing psychopathology. CONCLUSIONS: Within the largest study of CD in girls performed to date, we found compelling evidence for sex differences in comorbidity patterns and clinical presentation of CD. Our findings further support aspects of the 'gender paradox' and 'delayed-onset pathway' hypotheses by showing that girls with CD had higher rates of comorbid lifetime mental disorders and functional impairments, and they usually developed CD during adolescence. These novel data on sex-specific clinical profiles of CD will be critical in informing intervention and prevention programmes. En ligne : http://dx.doi.org/10.1111/jcpp.13428 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=457 [article] Sex differences in psychiatric comorbidity and clinical presentation in youths with conduct disorder [Texte imprimé et/ou numérique] / K. KONRAD, Auteur ; G. KOHLS, Auteur ; S. BAUMANN, Auteur ; A. BERNHARD, Auteur ; A. MARTINELLI, Auteur ; Katharina ACKERMANN, Auteur ; A. SMARAGDI, Auteur ; K. GONZALEZ-MADRUGA, Auteur ; A. WELLS, Auteur ; J. C. ROGERS, Auteur ; R. PAULI, Auteur ; R. CLANTON, Auteur ; R. BAKER, Auteur ; L. KERSTEN, Auteur ; M. PRÄTZLICH, Auteur ; H. OLDENHOF, Auteur ; L. JANSEN, Auteur ; A. KLEEVEN, Auteur ; Aitana BIGORRA, Auteur ; A. HERVAS, Auteur ; I. KEREXETA-LIZEAGA, Auteur ; E. SESMA-PARDO, Auteur ; M. ANGEL GONZALEZ-TORRES, Auteur ; R. SIKLÓSI, Auteur ; R. DOCHNAL, Auteur ; Z. KALOGERAKIS, Auteur ; M. PIRLYMPOU, Auteur ; L. PAPADAKOS, Auteur ; H. CORNWELL, Auteur ; W. SCHARKE, Auteur ; Dimitris DIKEOS, Auteur ; A. FERNÁNDEZ-RIVAS, Auteur ; A. POPMA, Auteur ; C. STADLER, Auteur ; B. HERPERTZ-DAHLMANN, Auteur ; Stephane A. DE BRITO, Auteur ; G. FAIRCHILD, Auteur ; C. M. FREITAG, Auteur . - p.218-228. Langues : Anglais (eng) in Journal of Child Psychology and Psychiatry > 63-2 (February 2022) . - p.218-228 Mots-clés : Conduct disorder  callous-unemotional traits  psychiatric comorbidity  sex differences Index. décimale : PER Périodiques Résumé : BACKGROUND: Conduct disorder (CD) rarely occurs alone but is typically accompanied by comorbid psychiatric disorders, which complicates the clinical presentation and treatment of affected youths. The aim of this study was to investigate sex differences in comorbidity pattern in CD and to systematically explore the 'gender paradox' and 'delayed-onset pathway' hypotheses of female CD. METHODS: As part of the FemNAT-CD multisite study, semistructured clinical interviews and rating scales were used to perform a comprehensive phenotypic characterization of 454 girls and 295 boys with CD (9-18?years), compared to 864 sex- and age-matched typically developing controls. RESULTS: Girls with CD exhibited higher rates of current major depression, anxiety disorders, post-traumatic stress disorder and borderline personality disorder, whereas boys with CD had higher rates of current attention-deficit/hyperactivity disorder. In line with the 'gender paradox' hypothesis, relative to boys, girls with CD showed significantly more lifetime psychiatric comorbidities (incl. Alcohol Use Disorder), which were accompanied by more severe CD symptoms. Female and male youths with CD also differed significantly in their CD symptom profiles and distribution of age-of-onset subtypes of CD (i.e. fewer girls with childhood-onset CD). In line with the 'delayed-onset pathway' hypothesis, girls with adolescent-onset CD showed similar levels of dimensional psychopathology like boys with childhood-onset CD, while boys with adolescent-onset CD had the lowest levels of internalizing psychopathology. CONCLUSIONS: Within the largest study of CD in girls performed to date, we found compelling evidence for sex differences in comorbidity patterns and clinical presentation of CD. Our findings further support aspects of the 'gender paradox' and 'delayed-onset pathway' hypotheses by showing that girls with CD had higher rates of comorbid lifetime mental disorders and functional impairments, and they usually developed CD during adolescence. These novel data on sex-specific clinical profiles of CD will be critical in informing intervention and prevention programmes. En ligne : http://dx.doi.org/10.1111/jcpp.13428 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=457

Temporal and Geographical Variability of Prevalence and Incidence of Autism Spectrum Disorder Diagnoses in Children in Catalonia, Spain / L. PEREZ-CRESPO in Autism Research, 12-11 (November 2019)  

Public ISBD [article]  inAutism Research > 12-11 (November 2019) . - p.1693-1705 Titre : Temporal and Geographical Variability of Prevalence and Incidence of Autism Spectrum Disorder Diagnoses in Children in Catalonia, Spain Type de document : Texte imprimé et/ou numérique Auteurs : L. PEREZ-CRESPO, Auteur ; A. PRATS-URIBE, Auteur ; A. TOBIAS, Auteur ; E. DURAN-TAULERIA, Auteur ; R. CORONADO, Auteur ; A. HERVAS, Auteur ; M. GUXENS, Auteur Article en page(s) : p.1693-1705 Langues : Anglais (eng) Mots-clés : Europe  autistic disorder  child development disorder  epidemiology  neurodevelopmental disorders Index. décimale : PER Périodiques Résumé : This study aims to estimate the prevalence of autism spectrum disorders (ASD) in 2017 and the ASD diagnosis incidence between 2009 and 2017 in children living in Catalonia region in Spain, and their temporal and geographical variability. We used administrative data for all children aged 2-17 years who were insured in the public Catalan Health System between 2009 and 2017. We identified all ASD cases diagnosed between 2009 and 2017 (ICD-9 codes 299.0, 299.1, 299.8, and 299.9). We estimated the ASD prevalence in 2017 and the overall annual incidence between 2009 and 2017, then stratified by sex, age group, and healthcare area. We used Poisson regression models to assess temporal trends in the incidence and mixed-effects Poisson regression models to assess geographical variability. We observed an ASD prevalence of 1.23% (95% confidence interval [CI] 1.21-1.25) in 2017, with 1.95% (95% CI 1.92-1.99) for boys and 0.46% (95% CI 0.44-0.48) for girls, the highest prevalence being in 11- to 17-year-olds (1.80%, 95% CI 1.76-1.83). The ASD diagnosis incidence increased from 0.07% (95% CI 0.06-0.09) in 2009 to 0.23% (95% CI 0.21-0.24) in 2017, with a higher increase in girls, and in children aged 2-5 years at the time of diagnosis. We only observed geographical differences in prevalence in the 2017 data. We also detected a threefold increase in the diagnosis incidence overall, which was even more pronounced in girls and at early ages. In conclusion, the ASD prevalence observed in this study was 1.23% in 2017, with a sex ratio of 4.5 in favor of boys, which is consistent with previous studies. Autism Res2019. (c) 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Autism spectrum disorders (ASD) are currently well known in our society as one of the most common neurodevelopmental disorders during childhood. The results of our study showed that, in 2017 in Catalonia, slightly more than one in a 100 children had an ASD diagnosis, it was more common in boys than in girls, and also in older children. In addition, between 2009 and 2017, we observed an increase in the number of new cases diagnosed each year. The data presented in this study will assist in planning and evaluating the needs of health services in this geographical region. En ligne : http://dx.doi.org/10.1002/aur.2172 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=412 [article] Temporal and Geographical Variability of Prevalence and Incidence of Autism Spectrum Disorder Diagnoses in Children in Catalonia, Spain [Texte imprimé et/ou numérique] / L. PEREZ-CRESPO, Auteur ; A. PRATS-URIBE, Auteur ; A. TOBIAS, Auteur ; E. DURAN-TAULERIA, Auteur ; R. CORONADO, Auteur ; A. HERVAS, Auteur ; M. GUXENS, Auteur . - p.1693-1705. Langues : Anglais (eng) in Autism Research > 12-11 (November 2019) . - p.1693-1705 Mots-clés : Europe  autistic disorder  child development disorder  epidemiology  neurodevelopmental disorders Index. décimale : PER Périodiques Résumé : This study aims to estimate the prevalence of autism spectrum disorders (ASD) in 2017 and the ASD diagnosis incidence between 2009 and 2017 in children living in Catalonia region in Spain, and their temporal and geographical variability. We used administrative data for all children aged 2-17 years who were insured in the public Catalan Health System between 2009 and 2017. We identified all ASD cases diagnosed between 2009 and 2017 (ICD-9 codes 299.0, 299.1, 299.8, and 299.9). We estimated the ASD prevalence in 2017 and the overall annual incidence between 2009 and 2017, then stratified by sex, age group, and healthcare area. We used Poisson regression models to assess temporal trends in the incidence and mixed-effects Poisson regression models to assess geographical variability. We observed an ASD prevalence of 1.23% (95% confidence interval [CI] 1.21-1.25) in 2017, with 1.95% (95% CI 1.92-1.99) for boys and 0.46% (95% CI 0.44-0.48) for girls, the highest prevalence being in 11- to 17-year-olds (1.80%, 95% CI 1.76-1.83). The ASD diagnosis incidence increased from 0.07% (95% CI 0.06-0.09) in 2009 to 0.23% (95% CI 0.21-0.24) in 2017, with a higher increase in girls, and in children aged 2-5 years at the time of diagnosis. We only observed geographical differences in prevalence in the 2017 data. We also detected a threefold increase in the diagnosis incidence overall, which was even more pronounced in girls and at early ages. In conclusion, the ASD prevalence observed in this study was 1.23% in 2017, with a sex ratio of 4.5 in favor of boys, which is consistent with previous studies. Autism Res2019. (c) 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Autism spectrum disorders (ASD) are currently well known in our society as one of the most common neurodevelopmental disorders during childhood. The results of our study showed that, in 2017 in Catalonia, slightly more than one in a 100 children had an ASD diagnosis, it was more common in boys than in girls, and also in older children. In addition, between 2009 and 2017, we observed an increase in the number of new cases diagnosed each year. The data presented in this study will assist in planning and evaluating the needs of health services in this geographical region. En ligne : http://dx.doi.org/10.1002/aur.2172 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=412

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