Joshi Gagan, Wozniak Janet, Mick Eric, Doyle Robert, Hammerness Paul, Georgiopoulos Anna, Kotarski Meghan, Aleardi Megan, Williams Courtney, Walls Sarah, Biederman Joseph
Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston, Massachusetts 02114, USA.
J Child Adolesc Psychopharmacol. 2010 Feb;20(1):7-14. doi: 10.1089/cap.2008.0162.
The aim of this study was to evaluate the safety and efficacy of extended release carbamazepine (CBZ-ER) monotherapy in the treatment of pediatric bipolar disorder (BD).
This was an 8-week, open-label, prospective trial of CBZ-ER monotherapy (788 +/- 252 mg/day) to assess the effectiveness and tolerability of this compound in treating pediatric bipolar spectrum disorders. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale, Children's Depression Rating Scale, and Brief Psychiatric Rating Scale. Adverse events were assessed through spontaneous self-reports, vital signs weight monitoring, and laboratory analysis.
Of the 27 participating children with BD, 16 (59.%) completed the study. CBZ-ER treatment was associated with statistically significant, but modest, levels of improvement in mean YMRS scores (-10.1 +/- 10.2, p < 0.001) with end-point mean YMRS score (21.8 +/- 12.2) suggesting a lack of complete resolution of mania. CBZ-ER treatment also resulted in significant improvement in the severity of depressive, attention-deficit/hyperactivity disorder, and psychotic symptoms. With the exception of 2 participants who discontinued due to skin rash, CBZ-ER was well tolerated with marginal increase in body weight (0.8 +/- 2.5 kg, p = 0.04) and was not associated with any abnormal changes in laboratory parameters.
Open-label CBZ-ER treatment was beneficial for the treatment of BD in children. Future controlled trials are warranted.
本研究旨在评估缓释卡马西平（CBZ - ER）单药治疗儿童双相情感障碍（BD）的安全性和有效性。
这是一项为期8周的开放标签前瞻性试验，采用CBZ - ER单药治疗（788±252毫克/天），以评估该化合物治疗儿童双相谱系障碍的有效性和耐受性。评估包括Young躁狂评定量表（YMRS）、临床总体印象改善量表、儿童抑郁评定量表和简明精神病评定量表。通过自发自我报告、生命体征体重监测和实验室分析评估不良事件。
在27名参与研究的BD患儿中，16名（59%）完成了研究。CBZ - ER治疗与平均YMRS评分有统计学意义但适度的改善相关（-10.1±10.2，p < 0.001），终点平均YMRS评分为（21.8±12.2），提示躁狂未完全缓解。CBZ - ER治疗还使抑郁、注意力缺陷/多动障碍和精神病性症状的严重程度有显著改善。除2名因皮疹停药的参与者外，CBZ - ER耐受性良好，体重略有增加（0.8±2.5千克，p = 0.04），且与实验室参数的任何异常变化无关。
开放标签的CBZ - ER治疗对儿童BD治疗有益。未来有必要进行对照试验。
