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

Authors


  • 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.

Abstract

Objective:

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

Method:

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.

Results:

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.

Discussion:

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)

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