Findling Robert L, Frazier Thomas W, Youngstrom Eric A, McNamara Nora K, Stansbrey Robert J, Gracious Barbara L, Reed Michael D, Demeter Christine A, Calabrese Joseph R
Department of Psychiatry, Case Western Reserve University, and the University Hospitals of Cleveland, Cleveland, Ohio 44106-5080, USA.
J Clin Psychiatry. 2007 May;68(5):781-8. doi: 10.4088/jcp.v68n0519.
To determine if divalproex sodium was superior to placebo in the treatment of symptomatic youths who suffer from a bipolar spectrum disorder and who also have a parent with a diagnosis of a bipolar illness.
Youths, ages 5 to 17 years, meeting DSM-IV criteria for bipolar disorder not otherwise specified (NOS) or cyclothymia who also had at least 1 biological parent with bipolar illness were randomly assigned in a double-blind fashion to receive treatment with either dival-proex sodium or placebo for up to 5 years. Study participation ended if the subject required additional clinical intervention, if the patient developed treatment-related adverse events, or if the participant was not adherent with study procedures. The primary outcome measure was time to study discontinuation for any reason. The study was conducted from August 1997 to April 2003.
Fifty-six youths with a mean (SD) age of 10.7 (3.1) years were randomly assigned and received either divalproex sodium (N = 29) or placebo (N = 27). In spite of statistical power of 80% to detect hazard ratios of 2.2 or larger, the treatment groups did not significantly differ in survival time for discontinuation for any reason (p = .93) or discontinuation due to a mood event (p = .55). Changes in mood symptom ratings and psychosocial functioning from baseline to study discontinuation did not differ between groups (most significant p > .14). However, both groups did show improvements in mood symptoms and psychosocial functioning over time (all p values < .002). One patient, from the placebo group, ended study participation due to an adverse event.
These results suggest that, although well tolerated, divalproex sodium does not produce clinically meaningful improvements in the treatment of symptomatic youths suffering from either bipolar NOS or cyclothymia who are at genetic risk for developing bipolar disorder.
确定丙戊酸二钠在治疗患有双相情感障碍谱系疾病且父母一方被诊断为双相情感障碍的有症状青少年中是否优于安慰剂。
年龄在5至17岁、符合双相情感障碍未另行规定（NOS）或环性心境障碍的DSM-IV标准且至少有1名患有双相情感障碍的亲生父母的青少年，以双盲方式随机分配，接受丙戊酸二钠或安慰剂治疗，为期最长5年。如果受试者需要额外的临床干预、出现与治疗相关的不良事件或未遵守研究程序，则研究参与结束。主要结局指标是因任何原因停止研究的时间。该研究于1997年8月至2003年4月进行。
56名平均（标准差）年龄为10.7（3.1）岁的青少年被随机分配，接受丙戊酸二钠治疗（N = 29）或安慰剂治疗（N = 27）。尽管有80%的统计效力来检测2.2或更大的风险比，但治疗组在因任何原因停药的生存时间（p = 0.93）或因情绪事件停药的生存时间（p = 0.55）上没有显著差异。从基线到研究结束，两组在情绪症状评分和心理社会功能方面的变化没有差异（最显著的p > 0.14）。然而，两组随着时间的推移在情绪症状和心理社会功能方面均有改善（所有p值 < 0.002）。安慰剂组的1名患者因不良事件结束了研究参与。
这些结果表明，尽管丙戊酸二钠耐受性良好，但在治疗患有双相情感障碍NOS或环性心境障碍且有患双相情感障碍遗传风险的有症状青少年时，并未产生具有临床意义的改善。
Zotero 插件