Department of Psychiatry
Abdominal Pain; Adolescent; Antipsychotic Agents; Appetite; Benzodiazepines; Bipolar Disorder; Brief Psychiatric Rating Scale; Child; Child, Preschool; Disorders of Excessive Somnolence; Female; Humans; Male; Patient Compliance; Pirenzepine; Prospective Studies; Severity of Illness Index; Time Factors; Weight Gain
OBJECTIVE: The goal of this study was to assess the effectiveness and tolerability of olanzapine in the treatment of acute mania in children and adolescents.
METHODS: This was an 8-week, open-label, prospective study of olanzapine monotherapy (dose range 2.5-20 mg/day) involving 23 bipolar youths (manic, mixed, or hypomanic; 5-14 years old). Weekly assessments were made using the Young Mania Rating Scale (YMRS), Clinical Global Impressions Severity Scale (CGI-S), Brief Psychiatric Rating Scale, and Children's Depression Rating Scale. Adverse events were assessed through self-reports, vital sign and weight monitoring, laboratory analytes, and extrapyramidal symptom rating scales (Barnes Akathisia Scale, Simpson-Angus Scale, and Abnormal Involuntary Movement Scale).
RESULTS: Twenty-two of the 23 youths (96%) completed the study. Olanzapine treatment was associated with significant improvement in mean YMRS score (-19.0 +/- 9.2, p < 0.001). Using predefined criteria for improvement of > or = 30% decline in the YMRS and a CGI-S Mania score of < or = 3 at endpoint, the overall response rate was 61%. Overall, olanzapine was well tolerated, and extrapyramidal symptom measures were not significantly different from baseline. Body weight increased significantly over the study (5.0 +/- 2.3 kg, p < 0.001).
CONCLUSIONS: Open-label olanzapine treatment was efficacious and well tolerated in the treatment of acute mania in youths with bipolar disorder. Future placebo-controlled, double-blind studies are warranted.
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This is a copy of an article published in the Journal of Child and Adolescent Psychopharmacology. © 2001 Mary Ann Liebert, Inc.
DOI of Published Version
J Child Adolesc Psychopharmacol. 2001 Fall;11(3):239-50. Link to article on publisher's site
Journal of child and adolescent psychopharmacology
Frazier, Jean A.; Biederman, Joseph; Tohen, Mauricio F.; Feldman, Peter D.; Jacobs, Thomas G.; Toma, Verna; Rater, Michael A.; Tarazi, Reem A.; Kim, Grace S.; Garfield, Stacey B.; Sohma, Mari; Gonzalez-Heydrich, Joseph; Risser, Richard C.; and Nowlin, Zachary M., "A prospective open-label treatment trial of olanzapine monotherapy in children and adolescents with bipolar disorder" (2001). Psychiatry Publications and Presentations. 385.