在双相情感障碍患者中，齐拉西酮联合心境稳定剂：一项 6 个月、随机、安慰剂对照、双盲试验。

Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial.

机构信息

Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX 78229, USA.

出版信息

J Clin Psychiatry. 2010 Feb;71(2):130-7. doi: 10.4088/JCP.09m05482yel. Epub 2010 Jan 26.

DOI:10.4088/JCP.09m05482yel

PMID:20122373

Abstract

OBJECTIVE

To evaluate the efficacy and safety of ziprasidone adjunctive to a mood stabilizer for the maintenance treatment of bipolar mania.

METHOD

Subjects with DSM-IV bipolar I disorder with a Mania Rating Scale score > or = 14 were enrolled. Subjects achieving > or = 8 consecutive weeks of stability with open-label ziprasidone (80-160 mg/d) and lithium or valproate (period 1) were randomly assigned in the 6-month, double-blind maintenance period (period 2) to ziprasidone plus mood stabilizer or placebo plus mood stabilizer. The primary and key secondary end points were the time to intervention for a mood episode and time to discontinuation for any reason, respectively. Inferential analysis was performed using a Kaplan-Meier product-limit estimator (log-rank test). The study was conducted from December 2005 to May 2008.

RESULTS

A total of 127 and 113 subjects were randomly assigned to ziprasidone and placebo, respectively. Intervention for a mood episode was required in 19.7% and 32.4% of ziprasidone and placebo subjects, respectively. The time to intervention for a mood episode was significantly longer for ziprasidone than placebo (P = .0104). The median time to intervention for a mood episode among those requiring such an intervention (n = 61) was 43.0 days for ziprasidone versus 26.5 days for placebo. The time to discontinuation for any reason was significantly longer for ziprasidone (P = .0047). Adjunctive ziprasidone treatment was well tolerated. Among treatment-emergent adverse events occurring in > or = 5% of subjects in either treatment group during period 2, only tremor occurred more frequently in the ziprasidone versus placebo group (6.3% vs 3.6%).

CONCLUSIONS

Ziprasidone is an effective, safe, and well-tolerated adjunctive treatment with a mood stabilizer for long-term maintenance treatment of bipolar mania.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00280566.

摘要

目的

评估齐拉西酮辅助心境稳定剂治疗双相躁狂的疗效和安全性。

方法

纳入 DSM-IV 双相 I 型障碍且杨氏躁狂量表评分≥14 的受试者。在接受为期 8 周的齐拉西酮（80-160mg/d）和锂盐或丙戊酸盐的开放标签治疗后达到≥8 周稳定的受试者，在为期 6 个月的双盲维持期（第 2 期）被随机分配至齐拉西酮联合心境稳定剂或安慰剂联合心境稳定剂组。主要和关键次要终点分别为躁狂发作的干预时间和因任何原因停药的时间。使用 Kaplan-Meier 乘积限估计值（对数秩检验）进行推断性分析。研究于 2005 年 12 月至 2008 年 5 月进行。

结果

共有 127 例和 113 例受试者分别随机分配至齐拉西酮和安慰剂组。齐拉西酮和安慰剂组分别有 19.7%和 32.4%的受试者需要干预躁狂发作。齐拉西酮组的躁狂发作干预时间显著长于安慰剂组（P=0.0104）。需要干预躁狂发作的受试者（n=61）中，齐拉西酮组的中位躁狂发作干预时间为 43.0 天，安慰剂组为 26.5 天。因任何原因停药的时间显著长于安慰剂组（P=0.0047）。齐拉西酮辅助治疗的耐受性良好。在第 2 期的任一治疗组中，发生率≥5%的治疗中出现的不良事件中，只有震颤在齐拉西酮组比安慰剂组更常见（6.3% vs 3.6%）。