Single-dose pharmacokinetics of amphetamine extended-release tablets compared with amphetamine extended-release oral suspension.

OBJECTIVE: Evaluate the relative bioavailability of single-dose amphetamine extended-release tablet (AMPH ER TAB) 20 mg, swallowed whole or chewed, and amphetamine extended-release oral suspension (AMPH EROS) 2.5 mg/mL; evaluate food effect on AMPH ER TAB. METHODS: Healthy volunteers (18-55 years) were randomized to 1 dose of AMPH ER TAB 20 mg swallowed (fasted), chewed (fed/fasted), or 20 mg AMPH EROS (fasted). A crossover study design was used. Plasma samples were collected each period predose and at time points to 60 hours postdose. d- and l-amphetamine were measured and pharmacokinetic (PK) was calculated (90% confidence intervals of the ratios of the plasma levels) for AUC0-t, AUC0-∞, and Cmax. Comparative relative bioavailability between formulations was determined when ratios were within 80% and 125%. Safety was also assessed. RESULTS: Thirty-two subjects completed the study. AMPH ER TAB swallowed versus AMPH EROS (fasted): for d- and l-amphetamine, the total and peak exposure was similar: d: AUC0-t: 100.68% to 108.08%, AUC0-∞: 101.47% to 109.52%, Cmax: 98.10% to 103.17%; l: AUC0-t: 100.31% to 108.57%, AUC0-∞: 101.27% to 111.09%, Cmax: 98.2% to 103.37%. For d- and l-amphetamine when the tablet is swallowed whole, Tmax was 5.00 hours (with a range of 2.00-9.00 hours). AMPH ER TAB chewed versus AMPH EROS (fasted): for d- and l-amphetamine, the total and peak exposure was similar: d: AUC0-t: 99.23% to 106.62%, AUC0-∞: 99.58% to 107.59%, Cmax: 99.91% to 105.14%; l: AUC0-t: 98.16% to 106.35%, AUC0-∞: 98.44% to 108.11%, Cmax: 99.53% to 104.75%. For d- and l-amphetamine when the tablet has been chewed, Tmax was 5.00 hours (with a range of 3.00-7.00 hours). PK results were similar for patients in the fasted and fed groups, indicative of no presence of food effect. No serious adverse events (AEs) were reported, overall AE profiles between the tablet and oral suspension were comparable without any unanticipated safety concerns. CONCLUSIONS: Single doses of AMPH ER TAB for both d- and l-amphetamine demonstrated comparable bioavailability to a 20 mg dose of AMPH EROS, 2.5 mg/mL under fasted conditions when chewed and swallowed whole, and demonstrated equivalent peak and overall exposure without apparent food effect. AMPH ER TAB was well-tolerated and consistent with adverse events noted in other amphetamine formulations.

Time course of the effects of lisdexamfetamine dimesylate in two phase 3, randomized, double-blind, placebo-controlled trials in adults with binge-eating disorder.

OBJECTIVE: This study examined the time course of efficacy-related endpoints for lisdexamfetamine dimesylate (LDX) versus placebo in adults with protocol-defined moderate to severe binge-eating disorder (BED). METHODS: In two 12-week, double-blind, placebo-controlled studies, adults meeting DSM-IV-TR BED criteria were randomized 1:1 to receive placebo or dose-optimized LDX (50 or 70 mg). Analyses across visits used mixed-effects models for repeated measures (binge eating days/week, binge eating episodes/week, Yale-Brown Obsessive Compulsive Scale modified for Binge Eating [Y-BOCS-BE] scores, percentage body weight change) and chi-square tests (Clinical Global Impressions-Improvement [CGI-I; from the perspective of BED symptoms] scale dichotomized as improved or not improved). These analyses were not part of the prespecified testing strategy, so reported p values are nominal (unadjusted and descriptive only). RESULTS: Least squares mean treatment differences for change from baseline in both studies favored LDX over placebo (all nominal p values < .001) starting at Week 1 for binge eating days/week, binge-eating episodes/week, and percentage weight change and at the first posttreatment assessment (Week 4) for Y-BOCS-BE total and domain scores. On the CGI-I, more participants on LDX than placebo were categorized as improved starting at Week 1 in both studies (both nominal p values < .001). Across these efficacy-related endpoints, the superiority of LDX over placebo was maintained at each posttreatment assessment in both studies (all nominal p values < .001). DISCUSSION: In adults with BED, LDX treatment appeared to be associated with improvement on efficacy measures as early as 1 week, which was maintained throughout the 12-week studies.

Binge-eating disorder in the Swedish national registers: Somatic comorbidity.

OBJECTIVE: To evaluate associations between binge-eating disorder (BED) and somatic illnesses and determine whether medical comorbidities are more common in individuals who present with BED and comorbid obesity. METHOD: Cases (n = 850) were individuals with a BED diagnosis in the Swedish eating disorders quality registers. Ten community controls were matched to each case on sex, and year, month, and county of birth. Associations of BED status with neurologic, immune, respiratory, gastrointestinal, skin, musculoskeletal, genitourinary, circulatory, and endocrine system diseases were evaluated using conditional logistic regression models. We further examined these associations by adjusting for lifetime psychiatric comorbidity. Amongst individuals with BED, we explored whether comorbid obesity was associated with risk of somatic disorders. RESULTS: BED was associated with most classes of diseases evaluated; strongest associations were with diabetes [odds ratio (95% confidence interval) = 5.7 (3.8; 8.7)] and circulatory systems [1.9 (1.3; 2.7)], likely indexing components of metabolic syndrome. Amongst individuals with BED, those with comorbid obesity were more likely to have a lifetime history of respiratory [1.5 (1.1; 2.1)] and gastrointestinal [2.6 (1.7; 4.1)] diseases than those without comorbid obesity. Increased risk of some somatic disease classes in individuals with BED was not simply due to obesity or other lifetime psychiatric comorbidity. DISCUSSION: The association of BED with many somatic illnesses highlights the morbidity experienced by individuals with BED. Clinicians treating patients with BED should be vigilant for medical comorbidities. Nonpsychiatric providers may be the first clinical contact for those with BED underscoring the importance of screening in primary care. © 2016 The Authors International Journal of Eating Disorders Published by Wiley Periodicals, Inc. (Int J Eat Disord 2017; 50:58-65).

Impact of binge eating disorder on functional impairment and work productivity in an adult community sample in the United States.

AIM: This study compared functioning and productivity in individuals meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for binge eating disorder (BED) to those without BED. METHODS: A sample of US adults from the National Health and Wellness Survey completed an Internet survey in October 2013. In addition to BED diagnostic criteria, the survey assessed functional impairment and productivity, respectively, using the Sheehan Disability Scale (SDS) and Work Productivity and Activity Impairment (WPAI) questionnaire. Differences between BED and non-BED respondents were assessed using multivariate models controlling for factors, including age, sex and comorbidities. RESULTS: Of 22 397 respondents, 344 were categorised as BED respondents and 20 437 as non-BED respondents. Compared with non-BED respondents, BED respondents exhibited significantly (all P<.001) greater functional impairment on the SDS, as measured by mean±SD total (14.04±9.46 vs 3.41±6.36), work/school (3.86±3.62 vs 1.01±2.21), social life/leisure activities (5.29±3.49 vs 1.22±2.33) and family life/home responsibilities (4.89±3.44 vs 1.18±2.26) scores. Adjusted odds ratios (95% CIs) indicated that BED respondents were more impaired than non-BED respondents on the work/school (4.24 [3.33-5.40]), social life/leisure activities (6.37 [4.97-8.15]) and family life/home responsibilities (5.76 [4.51-7.34]) domains of the SDS. On the WPAI, BED respondents reported significantly (all P<.001) higher percentages (mean±SD) of absenteeism (9.59%±19.97% vs 2.90%±12.95%), presenteeism (30.00%±31.64% vs 10.86%±20.07%), work productivity loss (33.19%±33.85% vs 12.60%±23.22%) and activity impairment (43.52%±34.36% vs 19.94%±27.22%) than non-BED respondents. CONCLUSIONS: The findings suggest individuals with BED experience considerable impairment in functioning and work productivity compared with individuals without BED.

Treatment-seeking patients with binge-eating disorder in the Swedish national registers: clinical course and psychiatric comorbidity.

BACKGROUND: We linked extensive longitudinal data from the Swedish national eating disorders quality registers and patient registers to explore clinical characteristics at diagnosis, diagnostic flux, psychiatric comorbidity, and suicide attempts in 850 individuals diagnosed with binge-eating disorder (BED). METHOD: Cases were all individuals who met criteria for BED in the quality registers (N = 850). We identified 10 controls for each identified case from the Multi-Generation Register matched on sex, and year, month, and county of birth. We evaluated characteristics of individuals with BED at evaluation and explored diagnostic flux across eating disorders presentations between evaluation and one-year follow-up. We applied conditional logistic regression models to assess the association of BED with each comorbid psychiatric disorder and with suicide attempts and explored whether risk for depression and suicide were differentially elevated in individuals with BED with or without comorbid obesity. RESULTS: BED shows considerable diagnostic flux with other eating disorders over time, carries high psychiatric comorbidity burden with other eating disorders (OR 85.8; 95 % CI: 61.6, 119.4), major depressive disorder (OR 7.6; 95 % CI: 6.2, 9.3), bipolar disorder (OR 7.5; 95 % CI: 4.8, 11.9), anxiety disorders (OR 5.2; 95 % CI: 4.2, 6.4), and post-traumatic stress disorder (OR 4.3; 95 % CI: 3.2, 5.7) and is associated with elevated risk for suicide attempts (OR 1.8; 95 % CI: 1.2, 2.7). Depression and suicide attempt risk were elevated in individuals with BED with and without comorbid obesity. CONCLUSIONS: Considerable flux occurs across BED and other eating disorder diagnoses. The high psychiatric comorbidity and suicide risk underscore the severity and clinical complexity of BED.

A systematic review of the health-related quality of life and economic burdens of anorexia nervosa, bulimia nervosa, and binge eating disorder.

PURPOSE: To perform a systematic review of the health-related quality of life (HRQoL) and economic burdens of anorexia nervosa (AN), bulimia nervosa (BN), and binge eating disorder (BED). METHODS: A systematic literature search of English-language studies was performed in Medline, Embase, PsycINFO, PsycARTICLES, Academic Search Complete, CINAHL Plus, Business Source Premier, and Cochrane Library. Cost data were converted to 2014 Euro. RESULTS: Sixty-nine studies were included. Data on HRQoL were reported in 41 studies (18 for AN, 17 for BN, and 18 for BED), on healthcare utilization in 20 studies (14 for AN, 12 for BN, and 8 for BED), and on healthcare costs in 17 studies (9 for AN, 11 for BN, and only 2 for BED). Patients' HRQoL was significantly worse with AN, BN, and BED compared with healthy populations. AN, BN, and BED were associated with a high rate of hospitalization, outpatient care, and emergency department visits. However, patients rarely received specific treatment for their eating disorder. The annual healthcare costs for AN, BN, and BED were €2993 to €55,270, €888 to €18,823, and €1762 to €2902, respectively. CONCLUSIONS: AN, BN, and BED have a serious impact on patient's HRQoL and are also associated with increased healthcare utilization and healthcare costs. The burden of BED should be examined separately from that of BN. The limited evidence suggests that further research is warranted to better understand the differences in long-term HRQoL and economic burdens of AN, BN, and BED.

Validation of the yale-brown obsessive compulsive scale modified for binge eating.

OBJECTIVE: Establish the Yale-Brown obsessive compulsive scale modified for binge eating (YBOCS-BE) as a fit for purpose measure of treatment benefit in clinical trials of binge eating disorder (BED). METHODS: YBOCS-BE psychometric properties were evaluated with data from a Phase 2 randomized controlled trial of lisdexamfetamine dimesylate in 260 adults with BED. Assessments included: Cohen's effect size estimates of item-level sensitivity and scale-level external responsiveness; item-to-total correlations; Cronbach's alpha for internal consistency reliability; Spearman correlations against reference measures for construct validity; known-groups analyses for discriminating ability; t tests of within-group differences between baseline and post baseline visits for internal responsiveness; and multiple anchor-based approaches to estimate minimum clinically important change (MCIC). RESULTS: No significant distribution anomalies were seen. Items appear sensitive to treatment group differences. Item-to-total correlations were positive. Internal consistency is 0.81. Large correlations (>0.50) were seen between YBOCS-BE score change and the Clinical Global Impression-Improvement (CGI-I; 0.58) and score changes for the following; number of binge days (0.38), Clinical Global Impression-Severity (CGI-S; 0.57), the disinhibition (0.57) and hunger (0.52) subscales of the Three-Factor Eating Questionnaire (TFEQ), and the Barratt Impulsiveness Scale (BIS-11; 0.58). MCIC estimates range from -4 to -17. DISCUSSION: The YBOCS-BE was found to be a reliable and valid measure of an important and unique concept in BED-related clinical studies. Study limitations include using protocol-defined BED severity level and the exclusion of psychiatric comorbidities.

Single-Dose Pharmacokinetics of Amphetamine Extended-Release Oral Suspension in Healthy Adults.

Purpose: This single-dose pivotal study evaluated the pharmacokinetics of amphetamine extended-release oral suspension (AMPH EROS) under fasted and fed conditions and the relative bioavailability of AMPH EROS and immediate-release mixed amphetamine salts (IR MAS) in adults. Methods: This open-label, randomized, three-period, three-treatment, six-sequence crossover study enrolled 30 healthy adult participants who were randomly assigned to receive either 1 dose of AMPH EROS 18.8 mg under fed or fasted conditions or 30 mg of IR MAS under fasted conditions. Participants crossed over with a 7-day washout period between each of the three periods. Plasma samples were measured for Cmax, AUC0-t, AUC0-5, AUC5-t, and AUC0-∞ for comparative bioavailability. Results: The geometric mean ratios for Cmax, AUC0-t, and AUC0-∞ were within the 90% confidence limits [80.0%, 125.0%] for comparable bioavailability. There was no food effect for AMPH EROS. Both the AMPH EROS and IR MAS formulations were generally well tolerated with no serious adverse events reported. Conclusions: The bioavailability of a single dose of AMPH EROS was comparable to two 15 mg doses of IR MAS, given 4 hr apart, with no food effect or safety concerns observed.

Ziprasidone in Black patients with schizophrenia: analysis of four short-term, double-blind studies.

OBJECTIVE: To better understand the efficacy and tolerability of atypical antipsychotics among racial groups, we reviewed data from four short-term (4-6 weeks), fixed-dose, placebo-controlled trials of ziprasidone for black, white, and overall populations of patients with schizophrenia. METHODS: Efficacy of ziprasidone in the black, white, and overall schizophrenic populations was compared to placebo using standard efficacy measures (Positive and Negative Syndrome Scale [PANSS] total, PANSS negative, Brief Psychiatric Rating Scale [BPRS], Clinical Global Impression-Severity [CGI-S], CGI-Improvement [CGI-I]). RESULTS: Black patients receiving ziprasidone demonstrated statistically significant improvements from baseline in PANSS total, PANSS negative, and BPRS, and improvements in CGI-S and CGI-I (n=99-149) compared with placebo (n=41-66); improvements were comparable to those observed in the overall population (n=451-639) and the white population (n=310-430). Interaction effect (treatment by race) was not significant for any efficacy variables. Ziprasidone was well-tolerated among black patients (n=175). Adjusted mean (least squares mean) overall weight gain in black patients receiving ziprasidone (n=124) was 1.8 kg. There were no increases in total cholesterol, triglycerides, or random glucose in the black population. CONCLUSION: Ziprasidone has similar efficacy and safety in black patients with schizophrenia compared with patients in the white and overall populations.

Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension in the Treatment of Children with Attention-Deficit/Hyperactivity Disorder.

OBJECTIVE: To determine whether amphetamine extended-release oral suspension (AMPH EROS) has an onset of effect at 30 minutes postdose in children with attention-deficit/hyperactivity disorder (ADHD). METHODS: This randomized, double-blind, two-treatment, two-sequence, placebo-controlled crossover pilot study enrolled subjects aged 6-12 years with ADHD and ADHD-Rating Scale-5 scores of ≥90th percentile for sex and age. An optimized dose of 5-20 mg/day of AMPH EROS was determined during a 1-week open-label dose optimization phase based on medication history, symptom control, and tolerability. Subjects completed a practice laboratory classroom then received 1 day of double-blind active drug or placebo each in random sequence during two double-blind laboratory classroom days. Subjects completed the first double-blind laboratory classroom, returned to open-label drug for 5 days, and then crossed over on day 6 during a second double-blind laboratory classroom. Double-blind dose was fixed at AMPH EROS 15, 17.5, or 20 mg. The primary end point was change from predose in the Swanson, Kotkin, Agler, M-Flynn, Pelham-Combined (SKAMP-C) Rating Scale score at 30 minutes postdose on two double-blind days. The key secondary end points were change from predose in the SKAMP-C score at 3 hours postdose for AMPH EROS compared with placebo and change from baseline Permanent Product Measure of Performance (PERMP) scores at 30 minutes and 3 hours postdose compared with placebo. Safety assessments included vital signs and adverse events (AEs). RESULTS: Eighteen subjects were enrolled in the study (14 males and 4 females) with a mean age of 9 years. At both 30 minutes and 3 hours postdose, changes from baseline in SKAMP-C for AMPH EROS versus placebo were statistically significant (p < 0.01 and p = 0.0002, respectively). PERMP scores were not statistically significantly improved at 30 minutes postdose for AMPH EROS relative to the placebo group. PERMP scores were statistically significantly improved at 3 hours postdose for AMPH EROS relative to the placebo group (PERMP problems attempted treatment difference least-squares [LS] mean [SE] = 60.3 [12.93], p = 0.0003; PERMP problems correct treatment difference LS mean [SE] = 61.6 [13.16], p = 0.0003). AEs (>10%) during the open-label phase included upper respiratory tract infection, fatigue, upper abdominal pain, headache, decreased appetite, and affect lability. CONCLUSIONS: AMPH EROS was effective in reducing ADHD symptoms at 30 minutes postdose as indicated by SKAMP-C score improvement, although improvements in PERMP scores at 30 minutes were not statistically significant. AEs were mild or moderate and consistent with those of other extended-release amphetamines.

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Effects of Lisdexamfetamine Dimesylate on Functional Impairment Measured on the Sheehan Disability Scale in Adults With Moderate-to-severe Binge Eating Disorder: Results from Two Randomized, Placebo-controlled Trials.

Objective: In two Phase III, randomized, placebo-controlled trials (NCT01718483 and NCT01718509 at ClinicalTrials.gov), lisdexamfetamine dimesylate (LDX) reduced binge eating days/week in adults with moderate-to-severe binge eating disorder (BED). We describe the effects of LDX (50mg and 70mg) on the Sheehan Disability Scale (SDS; exploratory endpoint) from both studies. Design: The SDS was assessed at baseline, Week 6, and Week 12/early termination. Analyses included mixed-effects models for repeated measures for the examination of SDS total and domain score changes and a generalized estimating equation model to assess dichotomized remission status (remission [total score ≤6] versus nonremission [total score >6]). Results: Least squares (95% confidence interval [CI]) mean treatment differences for SDS total score change from baseline at Week 12 were -2.80 (-3.98, -1.61) in Study 1 and -3.70 (-4.81, -2.58) in Study 2 (both p<0.001). Least squares (95% CI) mean treatment differences across SDS domains favored LDX over placebo in both studies for the change from baseline at Week 12 (work/school: -0.8 [-1.2, -0.4] and -1.1 [-1.5, -0.7], both p<0.001; social life/leisure activities: -1.0 [-1.4, -0.5] and -1.4 [-1.8, -1.0], both p<0.001; and family life/home responsibilities: -1.0 [-1.4, -0.5] and -1.3 [-1.7, -0.9], both p<0.001). Odds ratios (95% CI) for SDS remission versus nonremission favored LDX over placebo at Week 12 (Study 1: 2.39 [1.44, 3.96]; p<0.001 and Study 2: 5.12 [2.80, 9.33]; p<0.001). Conclusion: These findings indicate that LDX treatment is associated with improvement on the SDS in adults with moderate-to-severe BED.

Use and Value of the 7-Item Binge Eating Disorder Screener in Clinical Practice.

OBJECTIVE: To evaluate physician knowledge of and attitudes about binge-eating disorder (BED) and the value and ease-of-use of the 7-item Binge Eating Disorder Screener (BEDS-7) in clinical practice. METHODS: Two internet surveys (wave 1: April 15-May 6, 2015; wave 2: August 19-25, 2015) were administered to primary care physicians serving adults (PCPs-adults) and psychiatrists. Wave 1 invitees were US-based physicians spending ≥ 50% of their time in direct patient care and reporting "no" to "some to average" experience with eating-disorder patients. Respondents completing wave 1 qualified for wave 2. RESULTS: Among the 1,047 physicians who responded, 313 did not meet at least 1 of the screening criteria, including 3.15% of respondents who spent < 50% of their time in direct patient care. Overall, 122 PCPs-adults and 123 psychiatrists completed both waves. Physician groups spent similar mean ± SD amounts of time providing direct patient care (PCPs-adults: 94.66% ± 8.4%, psychiatrists: 91.15% ± 12.2%). Based on composite scores, BED knowledge increased from wave 1 to wave 2 in PCPs-adults (P < .001) and psychiatrists (P < .05). Composite scores pertaining to knowledge of and comfort with diagnosing and treating BED were lower for PCPs-adults than psychiatrists in both waves (all P < .001). Based on wave 2 responses, the BEDS-7 was used by 32.0% of PCPs-adults and 26.8% of psychiatrists. All BEDS-7 users (100%) indicated the screener was "very" or "somewhat" valuable, and nearly all users (psychiatrists: 100%, PCPs-adults: 97.4%) reported it was "very" or "reasonably" easy to use. BEDS-7 users reported that important uses of the screener included assisting clinicians in identifying BED patients and encouraging/initiating doctor-patient discussions about BED. CONCLUSIONS: These results support the utility of the BEDS-7 in clinical practice, with BEDS-7 users reporting that it is a highly valued and easy-to-use screener. Furthermore, both PCPs-adults and psychiatrists acknowledged the importance of being knowledgeable about BED.

Diagnosing binge eating disorder in a primary care setting.

Binge eating disorder (BED), now recognized as a distinct eating disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, is the most prevalent eating disorder. Although nearly half of individuals with BED are obese, BED also occurs in nonobese individuals. Despite the relatively high percentage of weight loss treatment-seeking individuals meeting BED criteria, primary care physicians may not be familiar with or have ever diagnosed BED. Many providers may also have difficulty distinguishing BED as a contributory factor in obesity. This review differentiates BED from other causes of obesity by describing how obese individuals with BED differ from obese individuals without BED and from nonobese individuals with BED in areas including psychopathology, behavior, genetics, physiology, quality of life and productivity. The ways in which health-care providers can identify individuals who may have BED are also highlighted so the proper course of treatment is pursued. Overall, obese individuals with BED demonstrate a number of key characteristics that differentiate them from obese individuals without eating disorders, including increased impulsivity in response to food stimuli with loss of control over eating, resulting in the consumption of more calories. They also experience significant guilt and other negative emotions following a meal. In addition, individuals with BED patients have more psychiatric comorbidity, display more psychopathology, exhibit longer binge durations, consume more meals as snacks during the day and have less dietary restraint compared with individuals with BED who are not obese. However, the differences between individuals with BED who are obese versus not obese are not as prominent. Taken together, the evidence appears to support the conclusion that BED is a unique and treatable neurobehavioral disorder associated with distinct behavioral and psychological profiles and distinct medical and functional outcomes, and that it is not merely a subtype of obesity.

Characteristics of binge eating disorder in relation to diagnostic criteria.

The objective of this review was to examine the evidentiary basis for binge eating disorder (BED) with reference to the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) diagnostic criteria for BED. A PubMed search restricted to titles and abstracts of English-language reviews, meta-analyses, clinical trials, randomized controlled trials, journal articles, and letters using human participants was conducted on August 7, 2015, using keywords that included "binge eating disorder," DSM-5, DSM-IV, guilt, shame, embarrassment, quantity, psychological, behavior, and "shape and weight concerns." Of the 257 retrieved publications, 60 publications were considered relevant to discussions related to DSM-5 diagnostic criteria and were included in the current review, and 20 additional references were also included on the basis of the authors' knowledge and/or on a review of the reference lists from relevant articles obtained through the literature search. Evidence supports the duration/frequency criterion for BED and the primary importance of loss of control and marked distress in identifying individuals with BED. Although overvaluation of shape/weight is not a diagnostic criterion, its relationship to the severity of BED psychopathology may identify a unique subset of individuals with BED. Additionally, individuals with BED often exhibit a clinical profile consisting of psychiatric (eg, mood, obsessive-compulsive, and impulsive disorders) and medical (eg, gastrointestinal symptoms, metabolic syndrome, and type 2 diabetes) comorbidities and behavioral profiles (eg, overconsumption of calories outside of a binge eating episode and emotional eating). Future revisions of the BED diagnostic criteria should consider the inclusion of BED subtypes, perhaps based on the overvaluation of shape/weight, and an evidence-based reassessment of severity criteria.

The neurobiological basis of binge-eating disorder.

Relatively little is known about the neuropathophysiology of binge-eating disorder (BED). Here, the evidence from neuroimaging, neurocognitive, genetics, and animal studies are reviewed to synthesize our current understanding of the pathophysiology of BED. Binge-eating disorder may be conceptualized as an impulsive/compulsive disorder, with altered reward sensitivity and food-related attentional biases. Neuroimaging studies suggest there are corticostriatal circuitry alterations in BED similar to those observed in substance abuse, including altered function of prefrontal, insular, and orbitofrontal cortices and the striatum. Human genetics and animal studies suggest that there are changes in neurotransmitter networks, including dopaminergic and opioidergic systems, associated with binge-eating behaviors. Overall, the current evidence suggests that BED may be related to maladaptation of the corticostriatal circuitry regulating motivation and impulse control similar to that found in other impulsive/compulsive disorders. Further studies are needed to understand the genetics of BED and how neurotransmitter activity and neurocircuitry function are altered in BED and how pharmacotherapies may influence these systems to reduce BED symptoms.

Knowledge of binge eating disorder: a cross-sectional survey of physicians in the United States.

OBJECTIVES: Binge eating disorder (BED)--now a designated disorder in the DSM-5--is the most prevalent eating disorder (ED), affecting 2-3% of the US population. This survey of US physicians assesses how BED is diagnosed, treated and referred. METHODS: Internists, family practitioners, obstetrics/gynecologist (OB/GYNs) and psychiatrists were randomly selected from a nationally-representative panel. Participants completed an online survey and reviewed case vignettes consistent with DSM-5-defined BED, then answered questions to elicit whether they would assess for psychiatric conditions including EDs. Those reporting they would screen and who correctly identified BED in vignettes received additional questions about BED diagnosis, treatment, and referral patterns. RESULTS: Of 278 physicians surveyed, 96% were board-certified and 87% had practiced >10 years. 23% were psychiatrists, 27% family practitioners, 31% internists and 19% OB/GYNs. 92% were 'somewhat likely' to screen for ED after reviewing DSM-5-consistent vignettes. 206 (74%) correctly identified BED. Of these, 33% and 68% reported they proactively screen eating habits for all patients and obese patients, respectively. 10% reported not screening eating habits even in the presence of ED symptoms. Fewer than half reported using DSM criteria in Diagnosing BED, and 56 (27%) did not recognize BED to be a discreet ED. CONCLUSION: Although ED awareness is improving, understanding BED as a distinct ED is lacking, which may result in low rates of screening and diagnosis. This study illustrates how taking a complete patient history (including probing BED characteristics) may be an effective first-line strategy for clinicians to facilitate optimal care for these patients.

Recognizing Binge-Eating Disorder in the Clinical Setting: A Review of the Literature.

OBJECTIVE: Review the clinical skills needed to recognize, diagnose, and manage binge-eating disorder (BED) in a primary care setting. DATA SOURCES: A PubMed search of English-language publications (January 1, 2008-December 11, 2014) was conducted using the term binge-eating disorder. Relevant articles known to the authors were also included. STUDY SELECTION/DATA EXTRACTION: Publications focusing on preclinical topics (eg, characterization of receptors and neurotransmitter systems) without discussing clinical relevance were excluded. A total of 101 publications were included in this review. RESULTS: Although BED is the most prevalent eating disorder, it is underdiagnosed and undertreated. BED can be associated with medical (eg, type 2 diabetes and metabolic syndrome) and psychiatric (eg, depression and anxiety) comorbidities that, if left untreated, can impair quality of life and functionality. Primary care physicians may find diagnosing and treating BED challenging because of insufficient knowledge of its new diagnostic criteria and available treatment options. Furthermore, individuals with BED may be reluctant to seek treatment because of shame, embarrassment, and a lack of awareness of the disorder. Several short assessment tools are available to screen for BED in primary care settings. Pharmacotherapy and psychotherapy should focus on reducing binge-eating behavior, thereby reducing medical and psychiatric complications. CONCLUSIONS: Overcoming primary care physician- and patient-related barriers is critical to accurately diagnose and appropriately treat BED. Primary care physicians should take an active role in the initial recognition and assessment of suspected BED based on case-finding indicators (eg, eating habits and being overweight), the initial treatment selection, and the long-term follow-up of patients who meet DSM-5 BED diagnostic criteria.

Development of the 7-Item Binge-Eating Disorder Screener (BEDS-7).

OBJECTIVE: Develop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists. METHODS: Items were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then refined in cognitive debriefing interviews with participants self-reporting BED characteristics (March 2014) and piloted in a multisite, cross-sectional, prospective, noninterventional study consisting of a semistructured diagnostic interview (to diagnose BED) and administration of the pilot Binge-Eating Disorder Screener (BEDS), Binge Eating Scale (BES), and RAND 36-Item Short-Form Health Survey (RAND-36) (June 2014-July 2014). The sensitivity and specificity of classification algorithms (formed from the pilot BEDS item-level responses) in predicting BED diagnosis were evaluated. The final algorithm was selected to minimize false negatives and false positives, while utilizing the fewest number of BEDS items. RESULTS: Starting with the initial BEDS item pool (20 items), the 13-item pilot BEDS resulted from the cognitive debriefing interviews (n = 13). Of the 97 participants in the noninterventional study, 16 were diagnosed with BED (10/62 female, 16%; 6/35 male, 17%). Seven BEDS items (BEDS-7) yielded 100% sensitivity and 38.7% specificity. Participants correctly identified (true positives) had poorer BES scores and RAND-36 scores than participants identified as true negatives. CONCLUSIONS: Implementation of the brief, patient-reported BEDS-7 in real-world clinical practice is expected to promote better understanding of BED characteristics and help physicians identify patients who may have BED.

Characterization of Binge-Eating Behavior in Individuals With Binge-Eating Disorder in an Adult Population in the United States.

OBJECTIVE: Characterize the frequency, duration, and severity of binge-eating behaviors in adults meeting DSM-5 criteria for binge-eating disorder (BED) in a large US community sample. METHODS: A representative sample of US adults from the National Health and Wellness Survey was recruited from an online panel and asked to respond to an Internet survey (conducted in October 2013) that included questions designed to assess binge-eating behaviors in relation to DSM-5 BED diagnostic criteria. RESULTS: Of 22,397 respondents, 344 self-reported meeting DSM-5 BED criteria (BED respondents). Most BED respondents reported that binge-eating episodes had occurred for the past 7-12 months (61.0%), and 93.6% reported ≥ 2-3 binge-eating episodes/wk. All BED respondents reported that "extreme" (52.6%) or "great" (47.4%) distress levels were associated with binge-eating episodes. Among BED respondents who agreed to provide detailed binge-eating behavior data after being invited to respond to additional survey questions, 40.6% reported binge eating on average > 1 time/d, and 59.2% reported binge eating 2-3 times/d. For 44.5% of BED respondents, binge-eating duration was 31-60 minutes. BED respondents reported that they "very often" (36.6%) or "often" (34.0%) had urges to binge eat between 7-10 pm. "Feeling disgusted with oneself, depressed, or guilty afterward" was the most bothersome symptom of binge eating for BED respondents (extremely bothersome: 41.9%). CONCLUSIONS: Binge-eating frequency among BED respondents averaged once daily. Most BED respondents exhibited binge-eating behavior for 7-12 months, often with severe symptoms. These findings highlight the disease burden of BED and have potential implications for diagnosing and treating BED.