title: Challenges in conducting a multi-site randomized clinical trial comparing treatments for adolescent anorexia nervosa.
abstract: OBJECTIVE
  To describe obstacles in the implementation of a controlled treatment trial of adolescent anorexia nervosa (AN).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Stanford University, School of Medicine, Stanford, CA 94305, USA. jimlock@stanford.edu
authors.forename: James
authors.initials: J
authors.lastname: Lock
authors.forename: Harry
authors.initials: H
authors.lastname: Brandt
authors.forename: Blake
authors.initials: B
authors.lastname: Woodside
authors.forename: Stewart
authors.initials: S
authors.lastname: Agras
authors.forename: W Katherine
authors.initials: WK
authors.lastname: Halmi
authors.forename: Craig
authors.initials: C
authors.lastname: Johnson
authors.forename: Walter
authors.initials: W
authors.lastname: Kaye
authors.forename: Denise
authors.initials: D
authors.lastname: Wilfley
mesh_terms: D000293:Adolescent; D000856:Anorexia Nervosa / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D001521:Behavior Therapy / Q000379:methods; D005196:Family Therapy / Q000379:methods; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use; D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018401:Sample Size; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use
chemical_list: D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors