Monika Schlögelhofer, Ashleigh Lin, Connie Markulev, Miriam R Schäfer, Patrick D McGorry, Barnaby Nelson, Rebekah Street, Nilufar Mossaheb, Stefan Smesny, Ian B Hickie, Gregor Berger, Eric Yh Chen, Lieuwe de Haan, Dorien H Nieman, Merete Nordentoft, Anita Riecher-Rössler, Swapna Verma, Andrew Thompson, Alison R Yung, G Paul Amminger
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We examined correlates of non-adherence with study medication (omega-3 PUFAs or placebo), including patient, illness and treatment factors, plus transition to psychosis. Non-adherence was defined as <75% study medication intake over 6 months and, post hoc, by the number of returned pills.</p><p><strong>Results: </strong>Of 285 randomized participants with baseline fatty acid data, 163 (57.2%) were non-adherent. In univariate analyses, non-adherence was associated with baseline omega-3 index, pre-baseline duration of untreated symptoms, smoking, cannabis use, lower baseline Social and Occupational Functioning Assessment Scale, Global Functioning: Social and Role Scale scores and transition to psychosis. Transition to psychosis risk was significantly lower in the adherent than non-adherent group (4.2%, 95% CI = 0.7-7.7% vs 17.3%, 95% CI = 10.4-24.2%), Kaplan-Meier Log-rank test, chi-square = 10.675, <i>p</i> = 0.001), independent of omega-3 PUFA treatment status. Similarly, Cox regression analysis, covarying for the aforementioned factors significantly associated with non-adherence, also revealed non-adherence as an independent predictor of transition to psychosis (<i>B</i> = 1.452, <i>p</i> = 0.005). Finally, non-adherence was also significantly associated with transition to psychosis, even when defining non-adherence by number of returned pills.</p><p><strong>Conclusion: </strong>Non-adherence predicted a higher risk of progressing to psychosis in UHR individuals. 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引用次数: 0
摘要
目的:不依从性是临床试验中的一个重要因素,但尚未在首次精神病发作超高风险(UHR)人群中进行研究。方法:探索性分析来自NEURAPRO的数据,这是一项多中心安慰剂对照试验,在304名UHR个体中进行了长链omega-3多不饱和脂肪酸(omega-3 PUFAs)。我们检查了不遵守研究药物(omega-3 PUFAs或安慰剂)的相关性,包括患者、疾病和治疗因素,以及向精神病的过渡。无依从性定义为:结果:285名具有基线脂肪酸数据的随机参与者中,163名(57.2%)无依从性。在单变量分析中,不依从性与基线omega-3指数、基线前未治疗症状持续时间、吸烟、大麻使用、较低的基线社会和职业功能评估量表、整体功能:社会和角色量表得分以及向精神病的过渡有关。与omega-3 PUFA治疗状态无关,依从组转变为精神病的风险显著低于非依从组(4.2%,95% CI = 0.7-7.7% vs 17.3%, 95% CI = 10.4-24.2%) (Kaplan-Meier Log-rank检验,卡方= 10.675,p = 0.001)。同样,Cox回归分析,协变上述因素与不依从性显著相关,也显示不依从性是过渡到精神病的独立预测因子(B = 1.452, p = 0.005)。最后,即使用退回药片的数量来定义不依从性,不依从性也与向精神病的转变显著相关。结论:不依从性预示着UHR个体发展为精神病的更高风险。需要进一步的研究来更好地了解导致不依从性的因素,以及不依从性与向精神病过渡的关系。
Association between non-adherence to fish oil or placebo as a risk factor of transition to psychosis in ultra-high-risk individuals in the NEURAPRO study.
Objective: Non-adherence is an important factor in clinical trials, which has not been investigated in people at ultra-high risk (UHR) of developing a first episode of psychosis.
Methods: Exploratory analysis of data from NEURAPRO, a multicenter, placebo-controlled trial of long-chain omega-3 polyunsaturated fatty acids (omega-3 PUFAs) in 304 individuals at UHR. We examined correlates of non-adherence with study medication (omega-3 PUFAs or placebo), including patient, illness and treatment factors, plus transition to psychosis. Non-adherence was defined as <75% study medication intake over 6 months and, post hoc, by the number of returned pills.
Results: Of 285 randomized participants with baseline fatty acid data, 163 (57.2%) were non-adherent. In univariate analyses, non-adherence was associated with baseline omega-3 index, pre-baseline duration of untreated symptoms, smoking, cannabis use, lower baseline Social and Occupational Functioning Assessment Scale, Global Functioning: Social and Role Scale scores and transition to psychosis. Transition to psychosis risk was significantly lower in the adherent than non-adherent group (4.2%, 95% CI = 0.7-7.7% vs 17.3%, 95% CI = 10.4-24.2%), Kaplan-Meier Log-rank test, chi-square = 10.675, p = 0.001), independent of omega-3 PUFA treatment status. Similarly, Cox regression analysis, covarying for the aforementioned factors significantly associated with non-adherence, also revealed non-adherence as an independent predictor of transition to psychosis (B = 1.452, p = 0.005). Finally, non-adherence was also significantly associated with transition to psychosis, even when defining non-adherence by number of returned pills.
Conclusion: Non-adherence predicted a higher risk of progressing to psychosis in UHR individuals. Further studies are needed to better understand factors contributing to non-adherence and how non-adherence is related to transition to psychosis.
期刊介绍:
Australian & New Zealand Journal of Psychiatry is the official Journal of The Royal Australian and New Zealand College of Psychiatrists (RANZCP).
The Australian & New Zealand Journal of Psychiatry is a monthly journal publishing original articles which describe research or report opinions of interest to psychiatrists. These contributions may be presented as original research, reviews, perspectives, commentaries and letters to the editor.
The Australian & New Zealand Journal of Psychiatry is the leading psychiatry journal of the Asia-Pacific region.