An open-label trial of divalproex sodium extended release for pediatric bipolar spectrum disorder in children age 6 - 12 years
An open-label trial of divalproex sodium extended release for pediatric bipolar spectrum disorder in children age 6 - 12 years作者机构：Pediatric Psychopharmacology Research Unit Massachusetts General Hospital Boston USA
出 版 物：《Open Journal of Psychiatry》 (精神病学期刊（英文）)
年 卷 期：2012年第2卷第2期
页 面：123-128页
学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学]
主 题：Bipolar Disorders Pediatric Psychopharmacology Open-Label
摘 要：Objective: To estimate the rate of response to divalproex sodium extended release in pediatric bipolar spectrum disorder in young children age 6 - 12. Methods: This was an 8-week, open-label treatment of youth with DSM-IV bipolar disorder with divalproex sodium extended release (ER) monotherapy. Severity of mania was assessed weekly with the Young Mania Rating Scale (YMRS). Results: The sample was 8.9 ± 2.0 years of age and predominantly male (83%). At study entry the mean YMRS score was 26.3 ± 4.5. Of the 18 subjects enrolled, 7 (39%) completed the 8 week course. We failed to find a clinically or statistically significant improvement with divalproex sodium ER. Pre-post comparisons at endpoint (LOCF) indicated an average response reduction of 6.1 ± 2.6 in the YMRS to a mean of 20.3 ± 8.1. Weight increased by 1.36 ± 0.7 kg (p = 0.08) from baseline to endpoint. Conclusion. Divalproex sodium ER monotherapy was associated with poor tolerability, was associated with clinically concerning weight gain but had modest therapeutic benefits in the management of symptoms of mania and depression in children with pediatric bipolar disorder.
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