Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies
| Autor: | Caleb Bliss, Leslie Citrome, Judith C. Kando |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Neuropsychiatric Disease and Treatment Yale-Brown Obsessive Compulsive Scale modified for Binge Eating binge eating days lisdexamfetamine dimesylate Placebo 03 medical and health sciences 0302 clinical medicine Binge-eating disorder Rating scale Internal medicine Severity of illness binge eating disorder medicine clinical rating scales Clinical significance Original Research Binge eating business.industry medicine.disease humanities 030227 psychiatry Clinical trial Clinical Global Impressions scale Compulsive behavior medicine.symptom business 030217 neurology & neurosurgery |
| Zdroj: | Neuropsychiatric Disease and Treatment |
| ISSN: | 1178-2021 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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