一项针对双相情感障碍儿童和青少年的齐拉西酮单药治疗前瞻性开放标签治疗试验。

A prospective open-label treatment trial of ziprasidone monotherapy in children and adolescents with bipolar disorder.

作者信息

Biederman Joseph, Mick Eric, Spencer Thomas, Dougherty Meghan, Aleardi Megan, Wozniak Janet

机构信息

Massachusetts General Hospital, Pediatric Psychopharmacology Research Department, 32 Fruit Street, Yawkey Center for Outpatient Care-Yaw-6A, Boston, MA 02114, USA.

出版信息

Bipolar Disord. 2007 Dec;9(8):888-94. doi: 10.1111/j.1399-5618.2007.00450.x.

DOI:10.1111/j.1399-5618.2007.00450.x

PMID:18076539

Abstract

OBJECTIVE

To assess the effectiveness and tolerability of ziprasidone for treating pediatric mania.

METHODS

This was an eight-week, open-label, prospective study of ziprasidone monotherapy (57.3 +/- 33.9 mg/day) in 21 bipolar youth [manic, mixed, or bipolar not otherwise specified (NOS); 6-17 years old]. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale (CGI-I), and Brief Psychiatric Rating Scale (BPRS). Adverse events were assessed through spontaneous self-reports, vital signs, weight monitoring, and laboratory analysis.

RESULTS

Fourteen of the 21 youth (67%) completed the study. Ziprasidone treatment was associated with clinically and statistically significant improvement in mean YMRS scores (-10.8 +/- 8.4, p < 0.0001) and 57% had a CGI-I <or=2 at endpoint. Ziprasidone was well tolerated with no statistically significant increase in body weight (0.6 +/- 0.4 kg, p = 0.2) or QTc interval (-3.7 +/- 4.7, p = 0.5).

CONCLUSIONS

Open-label ziprasidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder. Future placebo-controlled, double-blind studies are warranted.

摘要

目的

评估齐拉西酮治疗儿童躁狂症的有效性和耐受性。

方法

这是一项为期八周的开放性前瞻性研究，对21名双相情感障碍青少年[躁狂、混合或未另作说明的双相情感障碍（NOS）；6至17岁]采用齐拉西酮单药治疗（57.3±33.9毫克/天）。评估包括青年躁狂评定量表（YMRS）、临床总体印象改善量表（CGI-I）和简明精神病评定量表（BPRS）。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。

结果

21名青少年中有14名（67%）完成了研究。齐拉西酮治疗使平均YMRS评分在临床和统计学上有显著改善（-10.8±8.4，p<0.0001），57%的患者在研究终点时CGI-I≤2。齐拉西酮耐受性良好，体重（0.6±0.4千克，p = 0.2）或QTc间期（-3.7±4.7，p = 0.5）无统计学显著增加。