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

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 

Institution
Department of Psychiatry and Behavioral Sciences, Stanford University, School of Medicine, Stanford, California. jimlock@stanford.edu.

Source

Int J Eat Disord 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.

Language: ENG

Pub Type(s): JOURNAL ARTICLE PubMed ID: 21495052

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