NYMC Faculty Publications
DOI
10.2147/NDT.S158395
Journal Title
Neuropsychiatric Disease and Treatment
First Page
537
Last Page
546
Document Type
Article
Publication Date
2-1-2018
Department
Psychiatry and Behavioral Sciences
Abstract
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; Pr=0.319; Pr=0.647; Pr=0.741; P
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.
Recommended Citation
Citrome, L. L., Kando, J., & Bliss, C. (2018). 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, 14, 537-546. https://doi.org/10.2147/NDT.S158395
Publisher's Statement
Originally published in Neuropsychiatric Disease and Treatment, 14, 537-546. The original material can be found here.
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial 3.0 License
