一项随机、双盲、安慰剂对照的研究，评估了两种剂量范围的帕利哌酮长效制剂治疗精神分裂症谱系障碍患者的疗效。

A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder.

机构信息

Johnson & Johnson Pharmaceutical Research and Development, LLC, 1125 Trenton-Harbourton Rd-E12604, Titusville, NJ 08560, USA.

出版信息

J Clin Psychiatry. 2010 May;71(5):587-98. doi: 10.4088/JCP.09m05564yel.

DOI:10.4088/JCP.09m05564yel

PMID:20492853

Abstract

OBJECTIVE

This study was designed to assess efficacy and safety of paliperidone extended-release (ER) in patients with schizoaffective disorder.

METHOD

A randomized, 6-week, double-blind, placebo-controlled study was conducted. Subjects with a Structured Clinical Interview for DSM-IV diagnosis of schizoaffective disorder, Positive and Negative Syndrome Scale (PANSS) total score >or= 60, score >or= 4 on >or= 2 PANSS items (hostility, excitement, tension, uncooperativeness, poor impulse control), and Young Mania Rating Scale and/or Hamilton Depression Rating Scale, 21-item version scores >or= 16 were eligible. Subjects received higher-dose (12 mg/d) or lower-dose (6 mg/d) paliperidone ER. Dose adjustments by 3-mg increments were allowed until day 15. The study was conducted from October 2006 through February 2008.

RESULTS

A total of 316 subjects were randomly assigned to paliperidone ER lower dose (n = 109), higher dose (n = 100), or placebo (n = 107). Mean +/- SD modal dose in lower- and higher-dose groups: 5.7 +/- 0.9 and 11.6 +/- 1.0 mg/d, respectively. Mean +/- SE PANSS total score (primary outcome) improved significantly with higher-dose paliperidone ER versus placebo (-32.4 +/- 2.1 versus -24.1 +/- 2.1; P = .003). Change with lower-dose paliperidone ER (-27.7 +/- 2.1) was not significantly different from placebo (P = .187). No new safety issues were identified; common adverse events were headache (placebo: 16.8%; paliperidone ER: lower dose, 13.9%, higher dose, 13.3%) and tremor (3.7%, 12.0%, 11.2%, respectively). Mean prolactin and weight changes were greater with active treatment than placebo.

CONCLUSIONS

Higher-dose paliperidone ER was effective and well tolerated in patients with acute schizoaffective disorder. These findings and those from a companion study constitute the first registration program for antipsychotic treatment in schizoaffective disorder.

TRIAL REGISTRATION

clincaltrials.gov Identifier: NCT00397033.

摘要

目的

本研究旨在评估帕利哌酮长效（ER）在精神分裂症谱系障碍患者中的疗效和安全性。

方法

进行了一项随机、6 周、双盲、安慰剂对照研究。符合 DSM-IV 精神分裂症谱系障碍结构化临床访谈诊断、阳性和阴性综合征量表（PANSS）总分≥60、≥2 项 PANSS 项目（敌意、兴奋、紧张、不合群、冲动控制差）评分≥4、Young 躁狂评定量表和/或汉密尔顿抑郁评定量表，21 项版本评分≥16 的患者有资格参加。患者接受高剂量（12mg/d）或低剂量（6mg/d）帕利哌酮 ER。允许剂量增加 3mg，直至第 15 天。研究于 2006 年 10 月至 2008 年 2 月进行。

结果

共有 316 名患者被随机分配至帕利哌酮 ER 低剂量组（n=109）、高剂量组（n=100）或安慰剂组（n=107）。低剂量和高剂量组的平均±SD 模态剂量分别为 5.7±0.9mg/d 和 11.6±1.0mg/d。高剂量帕利哌酮 ER 与安慰剂相比，阳性和阴性综合征量表（PANSS）总分（主要结局）显著改善（-32.4±2.1 与-24.1±2.1；P=0.003）。低剂量帕利哌酮 ER 的变化（-27.7±2.1）与安慰剂无显著差异（P=0.187）。未发现新的安全问题；常见不良事件为头痛（安慰剂：16.8%；帕利哌酮 ER：低剂量 13.9%，高剂量 13.3%）和震颤（3.7%、12.0%、11.2%）。与安慰剂相比，活性治疗时催乳素和体重的平均变化更大。