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Challenges in conducting a multi-site randomized clinical trial comparing treatments for adolescent anorexia nervosa


  • The authors have the following financial disclosures: Drs. Lock and Agras receive royalties from Guilford Press for books related to Family-Based Treatment. Dr. Lock provides training and consultation for the Training Institute for Child and Adolescent Eating Disorders. Dr. Kaye is a consultant for the Denver Eating Disorder Center and receives grant funding from Astra Zeneca Pharmaceuticals. Drs. Halmi, Brandt, Wilfley, Woodside, and Johnson report no financial disclosures.



To describe obstacles in the implementation of a controlled treatment trial of adolescent anorexia nervosa (AN).


The original aim was to enter 240 participants with AN to one of four cells: Behavioral family therapy (BFT) plus fluoxetine; BFT plus placebo; systems family therapy (SFT) plus fluoxetine; SFT plus placebo.


Recruitment was delayed pending a satisfactory resolution concerning participant safety. After 6 months of recruitment it became clear that the medication was associated with poor recruitment leading to a study redesign resulting in a comparison of two types of family therapy with a projected sample size of 160. One site was unable to recruit and was replaced.


Problems with the delineation of safety procedures, recruitment, re-design of the study, and replacement of a site, were the main elements resulting in a 1-year delay. Suggestions are made for overcoming such problems in future AN trials. © 2011 by Wiley Periodicals, Inc. (Int J Eat Disord 2012)