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).
RCT Entities:
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: Evelyn Attia; Joanna E Steinglass; B Timothy Walsh; Yuanjia Wang; Peng Wu; Colleen Schreyer; Jennifer Wildes; Zeynep Yilmaz; Angela S Guarda; Allan S Kaplan; Marsha D Marcus Journal: Am J Psychiatry Date: 2019-01-18 Impact factor: 18.112