Journal of Child and Adolescent Psychopharmacology
A Prospective Open-Label Treatment Trial of Olanzapine Monotherapy in Children and Adolescents with Bipolar Disorder
Sep 2001, Vol. 11, No. 3 : 239 -250
A Prospective Open-Label Treatment Trial of Olanzapine Monotherapy in Children and Adolescents with Bipolar Disorder
Joseph Biederman, MD, Mauricio Tohen, MD
"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. [Zyprexa;Lilly]
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 <>
Using predefined criteria:
for improvement of ≥30% decline in the YMRS and a CGI-S Mania score of ≤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 <>
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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My daughter was already on Zyprexa when this study was done. In 2001 she was 13 years old, and had gained 50+ pounds.
Her eyes would roll upward in her head and she was unable to read. She was highly agitated, and on 15mg. a day. For a dx that started off with OCD>Childhood Bipolar>based on what criteria? adult criteria.
Imagine, this study was done on 5 year olds, under the care of Joseph Biederman.
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