Dataset Information

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

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; P<0.0001) and Y-BOCS-BE total scores (r=0.319; P<0.0001). Baseline ELA for CGI-S further characterized this relationship: a CGI-S score of 4 (moderately ill) corresponding to 3.504 BE days/week and a Y-BOCS-BE total score of 18.6. Nominally significant correlations with CGI-I scores were reported for changes from baseline at study endpoint for BE days/week (r=0.647; P<0.0001) and Y-BOCS-BE total scores (r=0.741; P<0.0001). ELA for CGI-I scores at study endpoint showed that a CGI-I score of 1 (very much improved) corresponds to a reduction from baseline of 4.504 BE days/week and 19.4 points for Y-BOCS-BE total score.

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.

SUBMITTER: Citrome L

PROVIDER: S-EPMC5819587 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Citrome Leslie L Kando Judith C JC Bliss Caleb C

Neuropsychiatric disease and treatment 20180215

<h4>Objectives</h4>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.<h4>Clinical trial registration</h4>NCT01718483 (ClinicalTrials.gov/ct2/show/N ...[more]

PMID: 29497297

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Project description:ImportanceThe ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important.ObjectiveTo assess lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder.Design, setting, and participantsA multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults met DSM-IV-R binge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions-Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase.InterventionsLisdexamfetamine administration.Main outcomes and measuresThe primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events.ResultsOf the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized lisdexamfetamine responders (placebo, n = 138; lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37; P < .001) for time to relapse; the hazard ratio, based on a Cox proportional hazards model for lisdexamfetamine vs placebo, was 0.09 (95% CI, 0.04-0.23). The treatment-emergent adverse events observed were generally consistent with the known profile of lisdexamfetamine.Conclusions and relevanceRisk of binge-eating relapse over 6 months was lower in participants continuing lisdexamfetamine than in those randomized to placebo. The hazard for relapse was lower with lisdexamfetamine than placebo.Trial registrationclinicaltrials.gov Identifier: NCT02009163.

Project description:ObjectiveAlthough several effective behavioral treatments for binge-eating disorder (BED) exist, there are racial disparities in treatment access, with African-Americans and/or Black individuals having some of the lowest rates of access to care. Little is known about the experience and treatment of binge eating (BE) and BED among Black women.MethodThis systematic review, conducted according to PRISMA guidelines, synthesizes information related to BE and BED in Black women.ResultsA total of N = 38 studies met our eligibility criteria. We did not identify any systematic risk of bias across studies. The majority of included studies used cross-sectional survey methodology, and relied on interview (EDE) and self-report measures (particularly the Binge Eating Scale, BES) for the assessment of BE. Outcomes were inconsistently measured across trials, and there are limited data on the results of evidence-based treatments for BE/BED in Black women.DiscussionAlthough Black women have similar or higher rates of BE than White women, most research on BE and BED has focused on White women, with Black individuals underrepresented in clinical trials. Future research should examine evidence-based treatments to prevent and treat BED in this population.ObjetivoAunque existen varios tratamientos conductuales que son efectivos para el Trastorno de Atracones (BED, por sus siglas en inglés), existen disparidades raciales en el acceso a tratamiento, con individuos Afroamericanos y/o personas de color teniendo algunas de las tasas más bajas de acceso al cuidado de la salud. Se sabe muy poco acerca de la experiencia y tratamiento del comer en atracones (BE, por sus siglas en inglés) y BED entre mujeres afroamericanas y/o de color. MÉTODO: Esta revisión sistemática, realizada bajo lineamientos de las guías PRISMA, sintetiza información relacionada con BE y BED en mujeres afroamericanas y/o de color.ResultadosUn total de N = 38 estudios cumplieron con nuestros criterios de elegibilidad. No identificamos ningún riesgo sistemático de sesgo entre los estudios. La mayoría de los estudios incluidos utilizaron una metodología de encuesta transversal y se basaron en la entrevista (EDE) y las medidas de autoinforme (en particular, la Binge Eating Scale, BES) para la evaluación de BE. Los resultados se midieron de manera inconsistente entre los ensayos, y hay datos limitados sobre los resultados de los tratamientos basados en la evidencia para BE/BED en mujeres afroamericanas y/o de color. DISCUSIÓN: Aunque las mujeres afroamericanas y/o de color tienen tasas similares o más altas de BE que las mujeres blancas, la mayoría de las investigaciones sobre BE y BED se han centrado en las mujeres blancas, con individuos afroamericanos y/o de color subrepresentados en ensayos clínicos. La investigación futura debería examinar los tratamientos basados en la evidencia para prevenir y tratar el BED en esta población.

Project description:IntroductionResearch on binge eating disorder continues to evolve and advance our understanding of recurrent binge eating.MethodsThis mixed-methods, cross-sectional survey aimed to collect information from experts in the field about clinical aspects of adult binge eating disorder pathology. Fourteen experts in binge eating disorder research and clinical care were identified based on receipt of relevant federal funding, PubMed-indexed publications, active practice in the field, leadership in relevant societies, and/or clinical and popular press distinction. Anonymously recorded semi-structured interviews were analyzed by ≥2 investigators using reflexive thematic analysis and quantification.ResultsIdentified themes included: (1) obesity (100%); (2) intentional/voluntary or unintentional/involuntary food/eating restriction (100%); (3) negative affect, emotional dysregulation, and negative urgency (100%); (4) diagnostic heterogeneity and validity (71%); (5) paradigm shifts in understanding binge eating disorder (29%); and (6) research gaps/future directives (29%).DiscussionOverall, experts call for a better understanding of the relationship between binge eating disorder and obesity, including a need for clarification around the extent to which the two health issues are separate vs. related/overlapping. Experts also commonly endorse food/eating restriction and emotion dysregulation as important components of binge eating disorder pathology, which aligns with two common models of binge eating disorder conceptualization (e.g., dietary restraint theory and emotion/affect regulation theory). A few experts spontaneously identified several paradigm shifts in our understanding of who can have an eating disorder (beyond the anorexi-centric "thin, White, affluent, cis-gendered neurotypical female" stereotype), and the various factors that can drive binge eating. Experts also identified several areas where classification issues may warrant future research. Overall, these results highlight the continual advancement of the field to better understand adult binge eating disorder as an autonomous eating disorder diagnosis.

Project description:BackgroundInefficient mechanisms of emotional regulation appear essential in understanding the development and maintenance of binge-eating disorder (BED). Previous research focused mainly on a very limited emotion regulation strategies in BED, such as rumination, suppression, and positive reappraisal. Therefore, the aim of the study was to assess a wider range of emotional regulation strategies (i.e. acceptance, refocusing on planning, positive refocusing, positive reappraisal, putting into perspective, self-blame, other-blame, rumination, and catastrophizing), as well as associations between those strategies and binge-eating-related beliefs (negative, positive, and permissive), and clinical variables (eating disorders symptoms, both anxiety, depressive symptoms, and alexithymia).MethodsWomen diagnosed with BED (n = 35) according to the DSM-5 criteria and healthy women (n = 41) aged 22-60 years were assessed using: the Eating Attitudes Test-26, the Eating Beliefs Questionnaire-18, the Hospital Anxiety and Depression Scale, the Toronto Alexithymia Scale-20, the Cognitive Emotion Regulation Questionnaire, and the Difficulties in Emotion Regulation Scale. Statistical analyses included: Student t - tests or Mann-Whitney U tests for testing group differences between BED and HC group, and Pearson's r coefficient or Spearman's rho for exploring associations between the emotion regulation difficulties and strategies, and clinical variables and binge-eating-related beliefs in both groups.ResultsThe BED group presented with a significantly higher level of emotion regulation difficulties such as: nonacceptance of emotional responses, lack of emotional clarity, difficulties engaging in goal-directed behavior, impulse control difficulties, and limited access to emotion regulation strategies compared to the healthy controls. Moreover, patients with BED were significantly more likely to use maladaptive strategies (rumination and self-blame) and less likely to use adaptive strategies (positive refocusing and putting into perspective). In the clinical group, various difficulties in emotion regulation difficulties occurred to be positively correlated with the level of alexithymia, and anxiety and depressive symptoms. Regarding emotion regulation strategies, self-blame and catastrophizing were positively related to anxiety symptoms, but solely catastrophizing was related to the severity of eating disorder psychopathology.ConclusionsOur results indicate an essential and still insufficiently understood role of emotional dysregulation in BED. An especially important construct in this context seems to be alexithymia, which was strongly related to the majority of emotion regulation difficulties. Therefore, it might be beneficial to pay special attention to this construct when planning therapeutic interventions, as well as to the maladaptive emotion regulation strategies self-blame and catastrophizing, which were significantly related to BED psychopathology.

Dataset Information

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

Objectives

Clinical trial registration

Methods

Results

Conclusion

Publications

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

Similar Datasets

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