Wagner Karen Dineen, Weller Elizabeth B, Carlson Gabrielle A, Sachs Gary, Biederman Joseph, Frazier Jean A, Wozniak Patricia, Tracy Katherine, Weller Ronald A, Bowden Charles
University of Texas Medical Branch, Galveston, TX 77555-0188, USA.
J Am Acad Child Adolesc Psychiatry. 2002 Oct;41(10):1224-30. doi: 10.1097/00004583-200210000-00012.
This study evaluated the safety and effectiveness of divalproex sodium (Depakote ) in the treatment of youths with bipolar disorder.
Forty bipolar disorder patients aged 7 to 19 years, with a manic, hypomanic, or mixed episode, enrolled in an open-label study of divalproex (2-8 weeks), followed by a double-blind, placebo-controlled period (8 weeks).
Twenty-two subjects (61%) showed > or =50% improvement in Mania Rating Scale (MRS) scores during the open-label period. Significant ( <.001) improvements from baseline were seen for mean scores of all efficacy measures, including the MRS, Manic Syndrome Scale, Behavior and Ideation Scale, Brief Psychiatric Rating Scale, Clinical Global Impressions Severity scale, and Hamilton Rating Scale for Depression. Of the 23 subjects who discontinued the study during the open-label period, 6 (15%) discontinued for ineffectiveness, 6 (15%) for intolerance, 6 (15%) for noncompliance, and 6 (15%) for other reasons. Adverse events were generally mild or moderate in severity, with the most common being headache, nausea, vomiting, diarrhea, and somnolence. Laboratory data results were unremarkable. Too few subjects participated in the double-blind period for statistical analysis.
This study provides preliminary support for the safety and effectiveness of divalproex in the treatment of bipolar disorder in youths.
本研究评估丙戊酸二钠（德巴金）治疗双相情感障碍青少年的安全性和有效性。
40名年龄在7至19岁、有躁狂、轻躁狂或混合发作的双相情感障碍患者参加了一项丙戊酸二钠的开放标签研究（2 - 8周），随后进入双盲、安慰剂对照期（8周）。
22名受试者（61%）在开放标签期躁狂评定量表（MRS）得分改善≥50%。所有疗效指标的平均得分与基线相比均有显著改善（<.001），包括MRS、躁狂综合征量表、行为与观念量表、简明精神病评定量表、临床总体印象严重程度量表和汉密尔顿抑郁评定量表。在开放标签期退出研究的23名受试者中，6名（15%）因无效退出，6名（15%）因不耐受退出，6名（15%）因不依从退出，6名（15%）因其他原因退出。不良事件一般为轻度或中度，最常见的是头痛、恶心、呕吐、腹泻和嗜睡。实验室数据结果无异常。参与双盲期的受试者过少，无法进行统计分析。
本研究为丙戊酸二钠治疗青少年双相情感障碍的安全性和有效性提供了初步支持。
