Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies

Leslie Citrome,1 Judith C Kando,2 Caleb Bliss3 1Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Shire, Global Medical Affairs, Lexington, MA, USA; 3Shire, Biostatistics, Lexington, MA, USA Objectives: In two Phase III studies, lisdexamfetamine dimesy...

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Autores principales:	Citrome L, Kando JC, Bliss C
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	binge eating days binge eating disorder lisdexamfetamine dimesylate clinical rating scales Clinical Global Impressions scale Yale-Brown Obsessive Compulsive Scale modified for Binge Eating Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/b9326646c9c940f0a231e13815458866
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spelling	oai:doaj.org-article:b9326646c9c940f0a231e138154588662021-12-02T05:19:17ZRelationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies1178-2021https://doaj.org/article/b9326646c9c940f0a231e138154588662018-02-01T00:00:00Zhttps://www.dovepress.com/relationships-between-clinical-scales-and-binge-eating-days-in-adults--peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Leslie Citrome,1 Judith C Kando,2 Caleb Bliss3 1Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Shire, Global Medical Affairs, Lexington, MA, USA; 3Shire, Biostatistics, Lexington, MA, USA Objectives: In two Phase III studies, lisdexamfetamine dimesylate (LDX) reduced binge eating (BE) days/week in adults with moderate to severe binge eating disorder (BED) and was associated with improvement based on the Clinical Global Impressions–Improvement (CGI-I) scale. In this study, post hoc analyses examined the relationships between clinical observations and clinical rating scales in individuals with BED. Clinical trial registration: NCT01718483 (ClinicalTrials.gov/ct2/show/NCT01718483); NCT01718509 (ClinicalTrials.gov/ct2/show/NCT01718509). Methods: Two 12-week, double-blind, placebo-controlled studies randomized (1:1) adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, BED criteria and with protocol-defined moderate to severe BED (study 1, N=383; study 2, N=390) to placebo or dose-optimized LDX (50 or 70 mg). Assessments included the number of BE days/week, CGI–Severity (CGI-S) and CGI-I scores, and Yale-Brown Obsessive Compulsive Scale modified for Binge Eating (Y-BOCS-BE) total scores. For these post hoc analyses, data were pooled across studies and treatment arms. Statistical assessments included Spearman correlations and equipercentile linking analyses (ELA). Reported P-values are nominal (descriptive and not adjusted for multiplicity). Results: At baseline, nominally significant correlations with CGI-S scores were reported for BE days/week (r=0.374; P<0.0001) and Y-BOCS-BE total scores (r=0.319; P<0.0001). Baseline ELA for CGI-S further characterized this relationship: a CGI-S score of 4 (moderately ill) corresponding to 3.504 BE days/week and a Y-BOCS-BE total score of 18.6. Nominally significant correlations with CGI-I scores were reported for changes from baseline at study endpoint for BE days/week (r=0.647; P<0.0001) and Y-BOCS-BE total scores (r=0.741; P<0.0001). ELA for CGI-I scores at study endpoint showed that a CGI-I score of 1 (very much improved) corresponds to a reduction from baseline of 4.504 BE days/week and 19.4 points for Y-BOCS-BE total score. Conclusion: These post hoc analyses suggest that indices of global disease severity and improvement positively correlate with BE behavior and with obsessive and compulsive features of BED, measured by the Y-BOCS-BE, supporting the clinical relevance of BED treatment outcomes. Keywords: binge eating days, binge eating disorder, lisdexamfetamine dimesylate, clinical rating scales, Clinical Global Impressions scale, Yale-Brown Obsessive Compulsive Scale modified for Binge EatingCitrome LKando JCBliss CDove Medical Pressarticlebinge eating daysbinge eating disorderlisdexamfetamine dimesylateclinical rating scalesClinical Global Impressions scaleYale-Brown Obsessive Compulsive Scale modified for Binge EatingNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 14, Pp 537-546 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	binge eating days binge eating disorder lisdexamfetamine dimesylate clinical rating scales Clinical Global Impressions scale Yale-Brown Obsessive Compulsive Scale modified for Binge Eating Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	binge eating days binge eating disorder lisdexamfetamine dimesylate clinical rating scales Clinical Global Impressions scale Yale-Brown Obsessive Compulsive Scale modified for Binge Eating Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Citrome L Kando JC Bliss C Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies
description	Leslie Citrome,1 Judith C Kando,2 Caleb Bliss3 1Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Shire, Global Medical Affairs, Lexington, MA, USA; 3Shire, Biostatistics, Lexington, MA, USA Objectives: In two Phase III studies, lisdexamfetamine dimesylate (LDX) reduced binge eating (BE) days/week in adults with moderate to severe binge eating disorder (BED) and was associated with improvement based on the Clinical Global Impressions–Improvement (CGI-I) scale. In this study, post hoc analyses examined the relationships between clinical observations and clinical rating scales in individuals with BED. Clinical trial registration: NCT01718483 (ClinicalTrials.gov/ct2/show/NCT01718483); NCT01718509 (ClinicalTrials.gov/ct2/show/NCT01718509). Methods: Two 12-week, double-blind, placebo-controlled studies randomized (1:1) adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, BED criteria and with protocol-defined moderate to severe BED (study 1, N=383; study 2, N=390) to placebo or dose-optimized LDX (50 or 70 mg). Assessments included the number of BE days/week, CGI–Severity (CGI-S) and CGI-I scores, and Yale-Brown Obsessive Compulsive Scale modified for Binge Eating (Y-BOCS-BE) total scores. For these post hoc analyses, data were pooled across studies and treatment arms. Statistical assessments included Spearman correlations and equipercentile linking analyses (ELA). Reported P-values are nominal (descriptive and not adjusted for multiplicity). Results: At baseline, nominally significant correlations with CGI-S scores were reported for BE days/week (r=0.374; P<0.0001) and Y-BOCS-BE total scores (r=0.319; P<0.0001). Baseline ELA for CGI-S further characterized this relationship: a CGI-S score of 4 (moderately ill) corresponding to 3.504 BE days/week and a Y-BOCS-BE total score of 18.6. Nominally significant correlations with CGI-I scores were reported for changes from baseline at study endpoint for BE days/week (r=0.647; P<0.0001) and Y-BOCS-BE total scores (r=0.741; P<0.0001). ELA for CGI-I scores at study endpoint showed that a CGI-I score of 1 (very much improved) corresponds to a reduction from baseline of 4.504 BE days/week and 19.4 points for Y-BOCS-BE total score. Conclusion: These post hoc analyses suggest that indices of global disease severity and improvement positively correlate with BE behavior and with obsessive and compulsive features of BED, measured by the Y-BOCS-BE, supporting the clinical relevance of BED treatment outcomes. Keywords: binge eating days, binge eating disorder, lisdexamfetamine dimesylate, clinical rating scales, Clinical Global Impressions scale, Yale-Brown Obsessive Compulsive Scale modified for Binge Eating
format	article
author	Citrome L Kando JC Bliss C
author_facet	Citrome L Kando JC Bliss C
author_sort	Citrome L
title	Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies
title_short	Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies
title_full	Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies
title_fullStr	Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies
title_full_unstemmed	Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies
title_sort	relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two phase iii studies
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/b9326646c9c940f0a231e13815458866
work_keys_str_mv	AT citromel relationshipsbetweenclinicalscalesandbingeeatingdaysinadultswithmoderatetoseverebingeeatingdisorderintwophaseiiistudies AT kandojc relationshipsbetweenclinicalscalesandbingeeatingdaysinadultswithmoderatetoseverebingeeatingdisorderintwophaseiiistudies AT blissc relationshipsbetweenclinicalscalesandbingeeatingdaysinadultswithmoderatetoseverebingeeatingdisorderintwophaseiiistudies
_version_	1718400494359019520

Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies

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