An open-label study of lamotrigine adjunct or monotherapy for the treatment of adolescents with bipolar depression
An open-label study of lamotrigine adjunct or monotherapy for the treatment of adolescents with bipolar depression
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DOI：
10.1097/01.chi.0000194566.86160.a3
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发表时间：
2006-03-01
影响因子：
13.3
通讯作者：
Howe, M
中科院分区：
文献类型：
--
作者：
Chang, K;Saxena, K;Howe, M
目的：儿童双相抑郁症的治疗尚未得到很好的研究。作者希望前瞻性研究拉莫三嗪作为治疗或单药治疗正在经历抑郁发作的青少年双相情感障碍的疗效。方法：这是一项为期8周的拉莫三嗪开放标签试验，共有20名青少年参与，年龄12-17岁（平均年龄15.8岁; 7名男孩，13名女孩），诊断为双相情感障碍I、11岁或未另行说明，正在经历抑郁发作。拉莫三嗪的起始剂量为12.5 - 25 mg/天。主要缓解标准为第8周临床疗效总评量表-改善评分为1或2。第二个标准是儿童抑郁量表修订版评分至少下降50%。结果：19例受试者完成了试验。平均最终剂量为131.6 mg/天。7例受试者正在服用其他精神药物。16名受试者（84%）对主要标准有反应，12名（63%）对我们的次要标准有反应。11例受试者（58%）在第8周时被视为缓解。杨氏躁狂量表和外显攻击量表的评分也显着下降，在审判期间。在试验过程中没有明显的体重变化、皮疹或其他不良反应。结论：青少年双相抑郁症似乎对拉莫三嗪治疗有反应，无论是作为连续治疗还是单药治疗，抑郁、躁狂和攻击性都有所减少。需要在这一人群中进行更大规模的拉莫三嗪安慰剂对照研究。
Objective: The treatment of pediatric bipolar depression has not been well studied. The authors wished to prospectively study the efficacy of lamotrigine as adjunctive or monotherapy in adolescents with bipolar disorder who were experiencing a depressive episode. Method: This was an 8-week open-label trial of lamotrigine with 20 adolescents ages 12-17 years (mean age 15.8; 7 boys, 13 girls) with diagnoses of bipolar disorder I, 11, or not otherwise specified, who were experiencing a depressive episode. Lamotrigine was begun at 12.5 to 25 mg/day. Primary response criteria was a 1 or a 2 on the Clinical Global Impression-Improvement at week 8. A secondary criterion was at least a 50% decrease in Children's Depression Rating Scale-Revised scores. Results: Nineteen subjects completed the trial. The mean final dose was 131.6 mg/day. Seven subjects were taking other psychotropic medications. Sixteen subjects (84%) responded by primary criteria, and 12 (63%) responded to our secondary criteria. Eleven subjects (58%) were considered in remission at week 8. Young Mania Rating Scale and Overt Aggression Scale-Modified scores also decreased significantly during the trial. There was no significant weight change, rash, or other adverse effects during the trial. Conclusions: Adolescents with bipolar depression appeared to respond to lamotrigine treatment, whether as adjunctive therapy or monotherapy, with decreases in depression, mania, and aggression. Larger, placebo-controlled studies of lamotrigine are needed in this population.