Binge eating disorder pharmacotherapy clinical trails--who is left out?

OBJECTIVE This report examined the characteristics of subjects interested in binge eating disorder (BED) pharmacotherapy trails who were ineligible for participation. METHODS Data on 2685 potential subjects interested in participating in five different placebo-controlled monotherapy trails of BED were analysed. RESULTS Of the 2685 potential subjects, 1230 (45.8%) were ineligible because they did not meet entry criteria, 586 (21.8%) were eligible for participation, 531 (19.8%) were not interested in the study and 338 (12.6%) were not contacted. Among the 1230 ineligible candidates, 525 (42.7%) were taking exclusionary psychotropic medication, 305 (24.8%) did not meet specified BED criteria, 157 (12.7%) were out of the required age (n = 83) or weight (n = 74) range, 212 (17.2%) had prohibited medical (n = 78) or psychiatric (n = 134) disorders and 31 (2.5%) were participating in weight loss programmes. DISCUSSION Given the complexity of BED, future pharmacotherapy studies should examine a broader range of subjects, including subjects with subthreshold forms of BED, those with comorbid disorders and elderly subjects.