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

Int J Eat Disord. 2012 Mar;45(2):202-13. doi: 10.1002/eat.20923. Epub 2011 Apr 14.

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Anorexia Nervosa / drug therapy
  • Anorexia Nervosa / psychology
  • Anorexia Nervosa / therapy*
  • Behavior Therapy / methods
  • Family Therapy / methods
  • Female
  • Fluoxetine / therapeutic use
  • Humans
  • Patient Selection*
  • Randomized Controlled Trials as Topic*
  • Research Design*
  • Sample Size
  • Selective Serotonin Reuptake Inhibitors / therapeutic use

Substances

  • Serotonin Uptake Inhibitors
  • Fluoxetine