Ethyl-eicosapentaenoic acid in first-episode psychosis: A randomized, placebo-controlled trial

Ethyl-eicosapentaenoic acid in first-episode psychosis: A randomized, placebo-controlled trial
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DOI:
10.4088/jcp.v68n1206
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发表时间:
2007-12-01
影响因子:
5.3
通讯作者:
McGorry, Patrick D.
McGorry, Patrick D.
中科院分区:
医学2区
文献类型:
--
作者:
Berger, Gregor E.;Proffitt, Tina-Marie;McGorry, Patrick D.

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目的:探讨乙基二十碳五烯酸 (E-EPA) 增强治疗是否可以改善首发精神病 (FEP) 的抗精神病药疗效和耐受性。方法:我们对 80 名 FEP 患者进行了一项为期 12 周的随机、双盲、安慰剂对照试验,对 2 g E-EPA 增强治疗进行了研究。 69 名患者符合分析条件;对非情感性 FEP 患者亚组 (N=53) 进行事后分析。第一个参与者于 2000 年 11 月纳入,最后一个参与者于 2003 年 8 月完成试验。主要结果指标是症状变化评分和首次反应时间,而耐受性指标和累积抗精神病药物剂量是次要结果指标。结果:控制基线症状的协方差分析发现,第 12 周时 E-EPA 和安慰剂之间的症状变化评分没有显着平均差异。 Cox 回归分析显示,在非情感性精神病中,通过诊断交互作用 (p=.024) 进行首次反应时间的显着治疗有利于 E-EPA。累积缓解率的事后分析进一步证实了第 6 周时较高的缓解率(所有参与者为 42.9% [15/35] vs. 17.6% [6/34],p=.036;非情感性精神病子集为 54.2% [13/24] vs. 17.2% [5/29],p=.008);然而,第 12 周时差异不再显着。次要结果测量分析显示,E-EPA 增强的参与者在第 4 周至第 6 周之间需要的抗精神病药物减少了 20% (p=0.03),在最初 9 周内锥体外系副作用也较少 (p
Objective: To investigate if ethyl-eicosapentaenoic acid (E-EPA) augmentation improves antipsychotic efficacy and tolerability in first-episode psychosis (FEP).Method: We performed a 12-week, randomized, double-blind, placebo-controlled trial of 2-g E-EPA augmentation in 80 FEP patients. Sixty-nine patients were eligible for analysis; a post hoc analysis was computed for a subgroup of nonaffective FEP patients (N=53). The first participant was included in November 2000 and the last participant completed the trial in August 2003. Primary outcome measures were symptom change scores and time to first response, while tolerability measures and cumulative antipsychotic dose were secondary outcome measures.Results: Analysis of covariance controlling for baseline symptoms found no significant mean difference between E-EPA and placebo at week 12 for symptom change scores. Cox regression analysis revealed a significant treatment by diagnosis interaction (p=.024) for time to first response favoring E-EPA in nonaffective psychosis. Post hoc analysis for cumulative response rates further confirmed a higher response rate at week 6 (42.9% [15/35] vs. 17.6% [6/34] for all participants, p=.036; 54.2% [13/24] vs. 17.2% [5/29] for the nonaffective psychosis subset, p=.008); however, the difference at week 12 was no longer significant. Analysis of secondary outcome measures revealed that E-EPA - augmented participants needed 20% less antipsychotic medication between weeks 4 through 6 (p=.03), had less extrapyramidal side effects in the initial 9 weeks (p