Evaluating functional disability in clinical trials of lisdexamfetamine dimesylate in binge eating disorder using the Sheehan Disability Scale.
Int J Methods Psychiatr Res
; 30(1): e1849, 2021 03.
Article
em En
| MEDLINE
| ID: mdl-32841462
ABSTRACT
OBJECTIVES:
This study examined Sheehan Disability Scale (SDS) performance in binge eating disorder (BED) and explored relationships between SDS and BED outcomes using data from three placebo-controlled lisdexamfetamine (LDX) studies (two short-term, dose-optimized studies and one double-blind, randomized-withdrawal study) in adults with Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR)-defined BED.METHODS:
Analyses evaluated the psychometric properties of the SDS.RESULTS:
Confirmatory factor analysis supported a unidimensional total score in the short-term studies, with internal consistency (Cronbach's α) being 0.878. Total score exhibited good construct validity, with moderate and statistically significant correlations observed with Yale-Brown Obsessive Compulsive Scale modified for binge eating, Binge Eating Scale (BES), and EuroQol Group 5-Dimension 5-Level health status index scores. Known-groups validity analysis for the short-term studies demonstrated a significantly lower total score at end of study in participants considered "not ill" versus "ill" based on Clinical Global Impressions-Severity scores. SDS total score changes in the short-term studies were greater in responders than nonresponders based on binge eating abstinence or BES score. In the randomized-withdrawal study, SDS scores increased relative to baseline to a greater extent in participants randomized to placebo than LDX.CONCLUSIONS:
These analyses support the reliability, validity, and responsiveness to change of the SDS in individuals with BED.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Transtorno da Compulsão Alimentar
/
Dimesilato de Lisdexanfetamina
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Adult
/
Humans
Idioma:
En
Revista:
Int J Methods Psychiatr Res
Assunto da revista:
PSIQUIATRIA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Estados Unidos