Marangell Lauren B, Suppes Trisha, Zboyan Holly A, Prashad Sandhya J, Fischer Grace, Snow Diane, Sureddi Suresh, Allen John C
Mood Disorders Center, Menninger Department of Psychiatry, Baylor College of Medicine, and Department of Veterans Affairs, Houston, Texas, USA.
J Clin Psychiatry. 2008 Feb;69(2):183-9. doi: 10.4088/jcp.v69n0203.
Vagus nerve stimulation (VNS) appears to be an effective treatment option for patients with treatment-resistant unipolar and bipolar depression. The aim of the present study was to investigate the efficacy of VNS in a group of patients with treatment-resistant rapid-cycling bipolar disorder (RCBD) who were excluded from previous trials.
Nine outpatients with a DSM-IV-TR diagnosis of treatment-resistant RCBD were treated for 40 weeks with open-label VNS. The first patient was enrolled in June 2001, and the last patient completed the study in July 2005. Patients recorded their depression and mania mood symptoms on a daily basis throughout the study using the National Institute of Mental Health prospective life charting methodology and daily mood ratings. Patients were assessed every 2 weeks during the 2-month baseline period before device activation, every 2 weeks for the remaining 40 weeks of the study, and at the end of the study with the 24-item Hamilton Rating Scale for Depression (HAM-D-24), the 10-item Montgomery-Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), the Clinical Global Impressions (CGI) scale, the Global Assessment of Functioning (GAF) scale, and the 30-item Inventory of Depressive Symptomatology Self-Report (IDS-SR-30). Any adverse events or device complications were also recorded at each visit. The prospective life charts were analyzed by calculating the area under the curve. Statistical analysis was performed with a mixed-model repeated-measures regression analysis for repeated measures of the various rating scales. Significant p values were < or = .05.
Over the 12-month study period, VNS was associated with a 38.1% mean improvement in overall illness as compared to baseline (p = .012), as well as significant reductions in symptoms as measured by the HAM-D-24 (p = .043), MADRS (p = .003), CGI (p = .013), and GAF (p < .001) rating scales. Common adverse events were voice alteration during stimulation and hoarseness.
These data suggest that VNS may be an efficacious and well-tolerated treatment option for patients with treatment-resistant RCBD. Currently, no comparison is available in the literature. Larger randomized trials are needed to verify these findings.
迷走神经刺激（VNS）似乎是治疗难治性单相和双相抑郁症患者的一种有效治疗选择。本研究的目的是调查VNS在一组被排除在先前试验之外的难治性快速循环双相情感障碍（RCBD）患者中的疗效。
9名符合DSM-IV-TR诊断标准的难治性RCBD门诊患者接受了40周的开放标签VNS治疗。第一名患者于2001年6月入组，最后一名患者于2005年7月完成研究。在整个研究过程中，患者使用美国国立精神卫生研究所前瞻性生活图表方法和每日情绪评分，每天记录他们的抑郁和躁狂情绪症状。在设备激活前的2个月基线期内，每2周对患者进行一次评估，在研究的其余40周内每2周评估一次，并在研究结束时使用24项汉密尔顿抑郁量表（HAM-D-24）、10项蒙哥马利-阿斯伯格抑郁量表（MADRS）、杨氏躁狂量表（YMRS）、临床总体印象（CGI）量表、功能总体评估（GAF）量表和30项抑郁症状自评量表（IDS-SR-30）进行评估。每次就诊时还记录任何不良事件或设备并发症。通过计算曲线下面积分析前瞻性生活图表。对各种评分量表的重复测量进行混合模型重复测量回归分析以进行统计分析。显著p值<或=0.05。
在12个月的研究期内，与基线相比，VNS使总体病情平均改善了38.1%（p = 0.012），同时HAM-D-24（p = 0.043）、MADRS（p = 0.003）、CGI（p = 0.013）和GAF（p < 0.001）评分量表测量的症状也显著减轻。常见的不良事件是刺激期间声音改变和声音嘶哑。
这些数据表明，VNS可能是难治性RCBD患者一种有效且耐受性良好的治疗选择。目前，文献中尚无比较。需要更大规模的随机试验来验证这些发现。
