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Binge eating disorder pharmacotherapy clinical trails--who is left out?
Anna I Guerdjikova1, Susan L McElroy
1Department of Psychiatry, Lindner Center of Hope, Mason, OH 45267-0559, USA. guerdja@ucmail.edu
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.
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