Challenges in conducting a multi-site randomized clinical trial comparing treatments for adolescent anorexia nervosa.
Author(s) Lock J, Brandt H, Woodside B, Agras S, Halmi WK, Johnson C, Kaye W, Wilfley D
Department of Psychiatry and Behavioral Sciences, Stanford University, School of Medicine, Stanford, California. email@example.com.
Int J Eat Disord 2011 Apr 14.
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.
Pub Type(s): JOURNAL ARTICLE PubMed ID: 21495052