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.


CONCLUSIONS
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.
Guerdjikova
Anna I
AI
Department of Psychiatry, Lindner Center of Hope, Mason, OH 45267-0559, USA. guerdja@ucmail.edu
McElroy
Susan L
SL
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D015992:Body Mass Index; D052018:Bulimia Nervosa / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D004608:Eligibility Determination / Q000379:methods / Q000706:statistics & numerical data; D006801:Humans; D008875:Middle Aged; D010352:Patient Dropouts / Q000706:statistics & numerical data; D018579:Patient Selection; D011619:Psychotropic Drugs / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D055815:Young Adult
D011619:Psychotropic Drugs