title: A placebo-controlled pilot study of adjunctive olanzapine for adolescents with anorexia nervosa.
abstract: OBJECTIVE
  The objective of this study was to explore whether the addition of olanzapine versus placebo increases weight gain and improves psychological symptoms in adolescents with anorexia nervosa-restricting type who are participating in a comprehensive eating disorders treatment program.
  
  
  METHODS
  Twenty underweight females participated in this 10-week, double-blind, placebo-controlled pilot study of olanzapine. The primary efficacy measure was change in percentage of median body weight measured at baseline and weeks 5 and 10. Secondary efficacy measures included clinician-rated and self-reported measures of psychological functioning measured at 2-week intervals and eating disorder symptoms measured at baseline and weeks 5 and 10 as well as laboratory assessments (including indirect calorimetry), which were also performed at baseline and weeks 5 and 10. A mixed models approach to repeated measures analysis of variance was utilized to detect any treatment-by-time interaction.
  
  
  RESULTS
  Fifteen of 20 enrolled females (median age, 17.1 years; range, 12.3-21.8 years; mean body mass index, 16.3) completed this 10-week pilot study. Change in % median body weight did not differ between the treatment groups at midpoint or end of study. Both groups gained weight at a similar rate and had similar improvements in eating attitudes and behaviors, psychological functioning, and resting energy expenditure. A trend of increasing fasting glucose and insulin levels was found only in the olanzapine group at week 10.
  
  
  CONCLUSIONS
  These preliminary findings do not support a role for adjunctive olanzapine for underweight adolescent females with anorexia nervosa-restricting type who are receiving standard care in an eating disorder treatment program (clinical trials.gov; no. NCT00592930).
authors.affiliation: Division of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, New York 11004, USA. vkafanta@nshs.edu
authors.forename: Vivian
authors.initials: V
authors.lastname: Kafantaris
authors.forename: Ellen
authors.initials: E
authors.lastname: Leigh
authors.forename: Stanley
authors.initials: S
authors.lastname: Hertz
authors.forename: Alison
authors.initials: A
authors.lastname: Berest
authors.forename: Janet
authors.initials: J
authors.lastname: Schebendach
authors.forename: Wendy Meyer
authors.initials: WM
authors.lastname: Sterling
authors.forename: Ema
authors.initials: E
authors.lastname: Saito
authors.forename: Suzanne
authors.initials: S
authors.lastname: Sunday
authors.forename: Claudine
authors.initials: C
authors.lastname: Higdon
authors.forename: Neville H
authors.initials: NH
authors.lastname: Golden
authors.forename: Anil K
authors.initials: AK
authors.lastname: Malhotra
mesh_terms: D000293:Adolescent; D000856:Anorexia Nervosa / Q000188:drug therapy* / Q000628:therapy; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000627:therapeutic use*; D001786:Blood Glucose / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D002648:Child; D004311:Double-Blind Method; D005247:Feeding Behavior / Q000187:drug effects; D005260:Female; D006801:Humans; D007328:Insulin / Q000097:blood; D015233:Models, Statistical; D000077152:Olanzapine; D010865:Pilot Projects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D001786:Blood Glucose; D007328:Insulin; D001569:Benzodiazepines; D000077152:Olanzapine