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

Neuropsychiatric Disease and Treatment
Leslie CitromeCaleb Bliss

Abstract

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. NCT01718483 (ClinicalTrials.gov/ct2/show/NCT01718483); NCT01718509 (ClinicalTrials.gov/ct2/show/NCT01718509). Two 12-week, double-blind, placebo-controlled studies randomized (1:1) adults meetingDiagnostic 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). ReportedP-values are nominal (descriptive and not adjusted...Continue Reading

Citations

Jul 29, 2021·Journal of Psychopharmacology·David J Heal, Sharon L Smith

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NCT01718483
NCT01718509

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