Pavuluri Mani N, Henry David B, Carbray Julie A, Sampson Gwen A, Naylor Michael W, Janicak Philip G
Pediatric Bipolar Research Program, Department of Psychiatry, University of Illinois at Chicago (UIC), 912 South Wood Street, Chicago, IL 60612, USA.
J Child Adolesc Psychopharmacol. 2006 Jun;16(3):336-50. doi: 10.1089/cap.2006.16.336.
The aim of this study was to assess the safety and efficacy of risperidone augmentation of lithium in preschool-onset bipolar disorder (BD) among youth who insufficiently respond to lithium monotherapy.
Thirty-eight subjects between the ages of 4 and 17 years (mean age = 11.37 +/- 3.8 years) with onset of BD in preschool years (manic or mixed episode) entered this 12-month trial. All subjects received lithium monotherapy. Patients who failed to adequately respond to lithium monotherapy after 8 weeks and those who relapsed after an initial response were given risperidone augmentation for up to 11 months. The Young Mania Rating Scale (YMRS) was the primary outcome measure. Response was defined as a > or =50% decrease from baseline. Additional data were collected on diagnostic comorbidity, family history, number of hospitalizations, perinatal risk factors, history of physical or sexual abuse, Child Depression Rating Scale-Revised (CDRS-R), Clinical Global Impression (CGI) scale for BD (CGI-BP), Children's Global Assessment Scale (C-GAS), and adverse medication effects.
Of the 38 subjects treated with lithium monotherapy, 17 responded, whereas 21 required augmentation with risperidone. Response rate in the youths treated with lithium + risperidone was 85.7% (n = 18/21). Significant predictors of inadequate response to lithium monotherapy requiring augmentation were: (1) attention-deficit/hyperactivity disorder (ADHD), (2) severity at baseline, (3) history of sexual or physical abuse, and (4) preschool age. Combination treatment of lithium and risperidone was found to be safe and well tolerated.
A substantial proportion of youth with a history of preschool-onset BD treated with lithium were either nonresponders or partial responders. Subsequent augmentation of lithium with risperidone in these cases was well tolerated and efficacious. Potential predictors of lithium nonresponse identified in this study may guide the choice of medications earlier in the treatment process.
本研究旨在评估在对锂盐单一疗法反应不足的青少年中，利培酮增强锂盐治疗学龄前起病的双相情感障碍（BD）的安全性和有效性。
38名年龄在4至17岁（平均年龄 = 11.37 ± 3.8岁）、学龄前起病（躁狂或混合发作）的BD患者进入了这项为期12个月的试验。所有受试者均接受锂盐单一疗法。8周后对锂盐单一疗法反应不佳以及初始反应后复发的患者给予利培酮增强治疗，为期最长11个月。青年躁狂评定量表（YMRS）是主要结局指标。反应定义为较基线水平降低≥50%。还收集了关于诊断合并症、家族史、住院次数、围产期危险因素、身体或性虐待史、儿童抑郁评定量表修订版（CDRS - R）、双相情感障碍临床总体印象量表（CGI - BP）、儿童总体评估量表（C - GAS）以及药物不良反应的数据。
在接受锂盐单一疗法治疗的38名受试者中，17人有反应，而21人需要利培酮增强治疗。接受锂盐 + 利培酮治疗的青少年的反应率为85.7%（n = 18/21）。对需要增强治疗的锂盐单一疗法反应不足的显著预测因素为：（1）注意力缺陷/多动障碍（ADHD），（2）基线严重程度，（3）性或身体虐待史，以及（4）学龄前年龄。发现锂盐和利培酮联合治疗安全且耐受性良好。
相当一部分有学龄前起病BD病史且接受锂盐治疗的青少年要么无反应，要么部分反应。在这些病例中，随后用利培酮增强锂盐治疗耐受性良好且有效。本研究中确定的锂盐无反应的潜在预测因素可能会在治疗过程的早期指导药物选择。
