Ziprasidone in the treatment of acute bipolar mania: A three-week, placebo-controlled, double-blind, randomized trial
Ziprasidone in the treatment of acute bipolar mania: A three-week, placebo-controlled, double-blind, randomized trial
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DOI：
10.1176/appi.ajp.160.4.741
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发表时间：
2003-04-01
影响因子：
17.7
通讯作者：
Ice, K
中科院分区：
文献类型：
--
作者：
Keck, PE;Versiani, M;Ice, K
目的：以安慰剂为对照，评价齐拉西酮治疗成人急性双相躁狂的疗效和耐受性。方法：210例经DSM-IV轴1障碍结构化临床访谈证实的双相躁狂或混合性发作的患者(N=210)，随机分为两组，每组2：1，分别用齐拉西酮(每日两次，每次40-80 mg)或安慰剂双盲治疗3周。用情感障碍和精神分裂症量表、改变版(其中包括躁狂评定量表)、阳性和阴性症状量表、临床总体印象(CGI)严重程度量表、CGI改善量表和全球功能评估量表进行疗效评估。主要疗效变量是齐拉西酮组和安慰剂组之间从基线到终点(最后一次观察)在平均躁狂评定量表和CGI严重程度量表评分上的差异。安全性评估包括监测不良事件、生命体征、心电图结果和临床化验值，以及运动障碍和静坐不能的评估。结果：与基线和安慰剂相比，齐拉西酮在终点的所有主要和最次要的疗效指标上都有快速、持续的改善。治疗开始后2天内通常观察到显著改善，并在整个3周内保持不变。齐拉西酮耐受性好，锥体外系症状发生率低；未观察到体重增加和生命体征或其他安全参数的临床显著变化。结论：齐拉西酮单一治疗在减轻双相1障碍患者急性躁狂症状方面明显优于安慰剂。起效迅速，耐受性与安慰剂大致相当。
objective: The study evaluated the efficacy and tolerability of ziprasidone, compared with placebo, in the treatment of adult patients with acute bipolar mania.Method: Patients with a primary DSM-IV diagnosis of bipolar 1 disorder and a current manic or mixed episode (confirmed by the Structured Clinical Interview for DSM-IV Axis 1 Disorders, Patient Edition) (N=210) were randomly assigned in a 2:1 ratio to 3 weeks of double-blind treatment with ziprasidone (40-80 mg twice daily) or placebo. Efficacy was assessed with the Schedule for Affective Disorders and Schizophrenia, Change Version (which contains the Mania Rating Scale), Positive and Negative Syndrome Scale, Clinical Global impression (CGI) severity scale, CGI improvement scale, and Global Assessment of Functioning Scale. Primary efficacy variables were differences from baseline to endpoint (last observation carried forward) in mean Mania Rating Scale and CGI severity scale scores between the ziprasidone and placebo groups. Safety evaluations included monitoring of adverse events, vital signs, electrocardiogram results, and clinical laboratory values and assessment of movement disorders and akathisia.Results: Ziprasidone produced rapid, sustained improvements relative to baseline and placebo on all primary and most secondary efficacy measures at endpoint. Significant improvements were typically observed within 2 days after treatment commenced and were maintained throughout the 3 weeks. Ziprasidone was well tolerated and associated with a low rate of extrapyramidal symptoms; neither weight gain nor clinically significant changes in vital signs or other safety parameters were observed with ziprasidone.Conclusions: Ziprasidone monotherapy was significantly superior to placebo in reducing symptoms of acute mania in patients with bipolar 1 disorder. Onset of action was rapid, and tolerability of ziprasidone was generally comparable to that of placebo.