A double-blind, placebo-controlled study of risperidone for the treatment of
adolescents and young adults with anorexia nervosa: a pilot study.
Author(s): Hagman J, Gralla J, Sigel E, Ellert S, Dodge M, Gardner R, O'Lonergan T, Frank G,
Wamboldt MZ.
Affiliation(s): University of Colorado School of Medicine and Children's Hospital Colorado,
Aurora, CO 80045, USA. jennifer.hagman@childrenscolorado.org
Publication date & source: 2011, J Am Acad Child Adolesc Psychiatry. , 50(9):915-24
OBJECTIVE: The purpose of this double-blind, placebo-controlled exploratory pilot
study was to evaluate the safety and efficacy of risperidone for the treatment of
anorexia nervosa.
METHOD: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary
anorexia nervosa in an eating disorders program were randomized to receive
risperidone (n = 18) or placebo (n = 22). Subjects completed the Eating Disorder
Inventory 2, Color-A-Person Test, Body Image Software, and Multidimensional
Anxiety Scale for Children at baseline and regular intervals. Weight, laboratory
values, and electrocardiograms were monitored. Study medication was started at
0.5 mg daily and titrated upward weekly in 0.5-mg increments to a maximum dose of
4 mg until the subject reached a study endpoint.
RESULTS: The mean dose for the risperidone group was 2.5 mg and for the placebo
group was 3 mg for a mean duration of 9 weeks. Subjects taking risperidone had a
significant decrease on the Eating Disorder Inventory 2 Drive for Thinness
subscale over the first 7 weeks (effect size, 0.88; p = .002), but this
difference was not sustained to the end of the study (p = .13). The Eating
Disorder Inventory 2 Interpersonal Distrust subscale decreased significantly more
in subjects taking risperidone (effect size, 0.60; p = .03). Subjects taking
risperidone had increased prolactin levels (week 7; p = .001). There were no
significant differences between groups at baseline or the end of the study for
the other rating scales, change in weight, or laboratory measurements.
CONCLUSIONS: This study does not demonstrate a benefit for the addition of
risperidone in adolescents with anorexia nervosa during the weight-restoration
phase of care. Clinical trial registration information-A Double-Blind,
Placebo-Controlled Study of Risperidone for the Treatment of Anorexia Nervosa,
http://www.clinicaltrials.gov, NCT00140426.
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