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

• Published in: Neuropsychiatric disease and treatment 2018-01, Vol.14, p.537-546
• Main Authors: Citrome, Leslie, Kando, Judith C, Bliss, Caleb
• Format: Article
• Language: English
• Subjects: Adults; Anorexia nervosa; Attention deficit hyperactivity disorder; Binge eating; binge eating days; Binge eating disorder; Bulimia; Clinical Global Impressions scale; clinical rating scales; Clinical trials; Eating behavior; Eating disorders; Handbooks; Hyperactivity; Lisdexamfetamine; lisdexamfetamine dimesylate; Medical research; Mental disorders; Obesity; Original Research; Psychiatry; Schizophrenia; Studies; Substance abuse treatment; Yale-Brown Obsessive Compulsive Scale modified for Binge Eating
• ISSN: 1176-6328; 1178-2021; 1178-2021
• DOI: 10.2147/NDT.S158395

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 meeting , 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 -values are nominal (descriptive and not adjusted for multiplicity). At baseline, nominally significant correlations with CGI-S scores were reported for BE days/week ( =0.374;