Pawełczyk Tomasz, Grancow Marta, Kotlicka-Antczak Magdalena, Trafalska Elżbieta, Gębski Piotr, Szemraj Janusz, Żurner Natalia, Pawełczyk Agnieszka
Department of Affective and Psychotic Disorders, Medical University of Lodz, ul. Czechoslowacka 8/10, 92-216, Lodz, Poland.
Central Teaching Hospital, Medical University of Lodz, ul. Pomorska 251, 92-213, Lodz, Poland.
BMC Psychiatry. 2015 May 2;15:97. doi: 10.1186/s12888-015-0473-2.
Polyunsaturated fatty acid (PUFA) metabolism abnormalities have been long implicated in the etiology of schizophrenia. Although several randomized clinical trials have been carried out to assess the efficacy of omega-3 PUFA as add-on therapy in reducing psychopathology in populations of chronic patients with schizophrenia, only a few concern first-episode schizophrenia. The majority of these studies used a 12-week intervention based on ethyl-eicosapentaenoic acid (ethyl-EPA), however, with conflicting results. An intervention based on docosahexaenoic acid plus EPA has not been used in first-episode schizophrenia studies so far. No add-on supplementation studies have been carried out in medicated first-episode schizophrenia patients to assess the efficacy of omega-3 PUFA in preventing relapses.
A randomized placebo-controlled one-center trial will be used to compare the efficacy of 26-week intervention, composed of either 1320 mg/day of EPA and 880 mg/day of DHA, or olive oil placebo with regard to symptom severity and relapse rate in first-episode schizophrenia patients. Eighty-two patients (aged 16-35) will be recruited for the study. Eligible patients will be randomly allocated to one of two intervention arms: an active arm or a placebo arm (olive oil). The primary outcome measure of the clinical evaluation is schizophrenia symptom severity measured by the Positive and Negative Syndrome Scale (PANSS). Other outcomes include depressive symptoms, patient functioning and the level of insight. Correlates of change measured during the study will include structural brain changes, oxidative stress and defense, as well as neuroplasticity indicators. Metabolic syndrome components will also be assessed throughout the study.
By comparing 26-week administration of EPA + DHA or (placebo) olive oil as add-on therapy in reducing symptom severity and one-year relapse rate in patients with first episode schizophrenia, it is intended to provide new insights into the efficacy of omega-3 PUFA and correlates of change, and contribute to the improvement of mental health care for individuals suffering from schizophrenia.
This study has been registered at Clinical Trials.gov with the following number: NCT02210962 .
长期以来，多不饱和脂肪酸（PUFA）代谢异常一直被认为与精神分裂症的病因有关。尽管已经进行了多项随机临床试验，以评估ω-3多不饱和脂肪酸作为辅助治疗手段，在减轻慢性精神分裂症患者精神病理学症状方面的疗效，但仅有少数研究关注首发精神分裂症。这些研究大多采用基于二十碳五烯酸乙酯（ethyl-EPA）的12周干预措施，然而结果相互矛盾。迄今为止，基于二十二碳六烯酸加二十碳五烯酸的干预措施尚未应用于首发精神分裂症的研究中。尚未对正在接受药物治疗的首发精神分裂症患者进行辅助补充研究，以评估ω-3多不饱和脂肪酸预防复发的疗效。
一项随机、安慰剂对照的单中心试验将用于比较26周干预措施的疗效，该干预措施包括每日1320毫克二十碳五烯酸和每日880毫克二十二碳六烯酸，或橄榄油安慰剂，比较对象为首发精神分裂症患者的症状严重程度和复发率。将招募82名年龄在16至35岁之间的患者参与该研究。符合条件的患者将被随机分配至两个干预组之一：活性组或安慰剂组（橄榄油）。临床评估的主要结局指标是通过阳性和阴性症状量表（PANSS）测量的精神分裂症症状严重程度。其他结局指标包括抑郁症状、患者功能和洞察力水平。研究期间测量的变化相关因素将包括脑结构变化、氧化应激和防御，以及神经可塑性指标。在整个研究过程中还将评估代谢综合征的组成部分。
通过比较26周服用二十碳五烯酸+二十二碳六烯酸或（安慰剂）橄榄油作为辅助治疗手段，在减轻首发精神分裂症患者症状严重程度和一年复发率方面的效果，旨在为ω-3多不饱和脂肪酸的疗效及变化相关因素提供新的见解，并有助于改善精神分裂症患者的心理健康护理。
本研究已在ClinicalTrials.gov注册，注册号如下：NCT02210962 。
