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Published Online: 10 June 2011

A Placebo-Controlled Pilot Study of Adjunctive Olanzapine for Adolescents with Anorexia Nervosa

Publication: Journal of Child and Adolescent Psychopharmacology
Volume 21, Issue Number 3

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).

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cover image Journal of Child and Adolescent Psychopharmacology
Journal of Child and Adolescent Psychopharmacology
Volume 21Issue Number 3June 2011
Pages: 207 - 212
PubMed: 21663423

History

Published online: 10 June 2011
Published in print: June 2011

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Vivian Kafantaris
Division of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, New York.
Hofstra North Shore-LIJ School of Medicine at Hofstra University, Hempstead, New York.
Department of Biostatistics, The Feinstein Institute for Medical Research, Manhasset, New York.
Ellen Leigh
Medford, Massachusetts.
Stanley Hertz
Private Practice, Roslyn, New York.
Alison Berest
Division of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, New York.
Janet Schebendach
New York State Psychiatric Institute, New York, New York.
Wendy Meyer Sterling
Department of Adolescent Medicine, Cohen Children's Medical Center, New Hyde Park, New York.
Ema Saito
Division of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, New York.
Suzanne Sunday
Hofstra North Shore-LIJ School of Medicine at Hofstra University, Hempstead, New York.
Department of Biostatistics, The Feinstein Institute for Medical Research, Manhasset, New York.
Claudine Higdon
Division of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, New York.
Neville H. Golden
Department of Adolescent Medicine, Stanford University School of Medicine, Palo Alto, California.
Anil K. Malhotra
Division of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, New York.
Hofstra North Shore-LIJ School of Medicine at Hofstra University, Hempstead, New York.
Department of Biostatistics, The Feinstein Institute for Medical Research, Manhasset, New York.

Notes

Address correspondence to:Vivian Kafantaris, M.D.Division of Psychiatry ResearchThe Zucker Hillside Hospital75-59 263rd St.Glen Oaks, NY 11004E-mail: [email protected]

Disclosures

Eli Lilly had no access to the data and were not involved in data analysis or in the preparation of this manuscript. Dr. V. Kafantaris has received investigator-initiated research support in the form of donation of medication from GlaxoSmithKline, donation of medication and matching placebo from Astra Zeneca, Eli Lilly, Janssen, and Pfizer, and research funding from Pfizer for an unrelated, NIH-funded study. Dr. S. Hertz has been on the speakers' bureau for Eli Lilly, Pfizer, and Forest. Dr. N. Golden is a co-investigator on a study examining bone mineral density in adolescent girls, funded by TEVA Pharmaceuticals. There is nothing to disclose that might pose a conflict of interest for the present study. Dr. A.K. Malholtra is or has been a consultant to Eli Lilly, Merck, Janssen, BMS, and Vanda Pharmaceuticals. E. Leigh, Ph.D., Alison Berest, M.A., J. Schebendach, Ph.D., W.M. Sterling, M.S., E. Saito, M.D., C. Higdon, M.D., and S. Sunday, Ph.D., have no institutional or corporate/commercial relationships that might pose a conflict of interest.

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