1201. A prospective open-label treatment trial of olanzapine monotherapy in children and adolescents with bipolar disorder.
- Author
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Frazier JA, Biederman J, Tohen M, Feldman PD, Jacobs TG, Toma V, Rater MA, Tarazi RA, Kim GS, Garfield SB, Sohma M, Gonzalez-Heydrich J, Risser RC, and Nowlin ZM
- Subjects
- Abdominal Pain chemically induced, Adolescent, Antipsychotic Agents adverse effects, Appetite drug effects, Benzodiazepines, Brief Psychiatric Rating Scale, Child, Child, Preschool, Disorders of Excessive Somnolence chemically induced, Female, Humans, Male, Olanzapine, Patient Compliance, Pirenzepine adverse effects, Prospective Studies, Severity of Illness Index, Time Factors, Weight Gain drug effects, Antipsychotic Agents therapeutic use, Bipolar Disorder drug therapy, Pirenzepine analogs & derivatives, Pirenzepine therapeutic use
- Abstract
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.
- Published
- 2001
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