Yamada Yuji, Mishima Kazuo, Ohnishi Takashi, Suzuki Michio, Nemoto Takahiro, Mizuno Masafumi, Kishimoto Toshifumi, Tomita Hiroaki, Ozone Motohiro, Kitamura Shingo, Hashimoto Kenji, Nakagome Kazuyuki, Sumiyoshi Tomiki
Department of Psychiatry, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.
Department of Neuropsychiatry, Akita University Graduate School of Medicine, Akita, Japan.
Clin Psychopharmacol Neurosci. 2025 May 31;23(2):266-277. doi: 10.9758/cpn.24.1239. Epub 2024 Dec 3.
Schizophrenia is a major psychiatric illness which mostly begins in adolescence and leads to impairments of social functioning. Some patients with schizophrenia have been associated with ultra-high risk state for psychosis (UHR), a condition used to operationally represent the prodromal stage of the illness. In previous studies, the UHR and the progression to overt psychosis has been reported to be accompanied with alterations in the quality of sleep and the immune system, as represented by change of blood levels of cytokines. Currently, biomarkers to predict the development of psychosis in persons at UHR have not yet reached a steady consensus. Therefore, we present a study protocol to explore predictors of transitions to psychosis, in the realm of monitoring of sleep condition and cytokine measurement, in subjects with the UHR.
This is a multicenter, longitudinal cohort study participated by 7 hospitals in Japan. We will recruit 50 UHR people and 30 healthy volunteers as a control group, and measure positive symptom, depressive symptoms, cognitive function, and social function. Blood cytokines levels and sleep indices, as well as actigraphy data will be monitored. After the baseline assessment, clinical symptoms, sleep indices, and cytokine levels will be measured every 12 weeks for 52 weeks. Actigraphy devices will continue to be worn for 52 weeks, while social function will be assessed over 104 weeks. The results of this study are expected to facilitate the development of novel intervention therapies to reduce the risk of psychosis and improve functional outcomes.
精神分裂症是一种主要始于青春期并导致社会功能受损的严重精神疾病。一些精神分裂症患者与精神病超高风险状态（UHR）有关，这一状态在临床上用于代表该疾病的前驱期。在以往的研究中，据报道UHR以及向明显精神病的进展伴随着睡眠质量和免疫系统的改变，以细胞因子血液水平的变化为代表。目前，预测UHR人群精神病发展的生物标志物尚未达成稳定共识。因此，我们提出一项研究方案，在监测睡眠状况和测量细胞因子的领域，探索UHR受试者向精神病转变的预测因素。
这是一项由日本7家医院参与的多中心纵向队列研究。我们将招募50名UHR人群和30名健康志愿者作为对照组，测量阳性症状、抑郁症状、认知功能和社会功能。将监测血液细胞因子水平、睡眠指标以及活动记录仪数据。在基线评估后，每12周测量一次临床症状、睡眠指标和细胞因子水平，持续52周。活动记录仪将持续佩戴52周，而社会功能将在104周内进行评估。本研究结果有望促进新型干预疗法的开发，以降低精神病风险并改善功能结局。
