Clinical and Biomarker-Based Trajectories of Psychosis-Risk Populations in Kenya

摘要 母研究，“肯尼亚精神病风险人群的临床和基于生物标志物的轨迹”，旨在 在肯尼亚建立研究能力，使用最先进的多模式方法，以绘制临床结果， 处于发展为精神分裂症的临床高风险（CHD）的青少年和年轻成年人（目标1）。这涉及 通过购置研究级采集设备和软件，在内罗毕建立ERP/EEG基础设施; MRI升级，包括先进的扩散和fMRI BOLD成像能力;以及精心设计的研究培训。 该研究还收集了100名参与者在24个月内的多模式临床和生物标志物，包括 脑MRI、ERP/EEG、遗传学和皮质醇，以及来自50名健康志愿者的基线数据（目标2）。最后， 这项研究将检验这样一个假设，即肯尼亚少数民族的精神病结果将不同于 通过具有较少的精神病转换和改善的功能（目标3）来改善国际队列。 我们在本补充申请中的目标是使研究方案和评估与42项研究方案和评估协调一致。 ProNET和PRESCIENT网络内的国际站点，由加速医学资助 合作伙伴-精神分裂症（AMP-SCZ）财团。该补充的组成部分将允许：1）增加 纵向时间点的数量为15个，2）在纵向评估中包括健康对照，3） 包括被动和主动数字生物标志物评估，4）纳入AMP-SCZ评估培训， 加强监督，5）开发ERP/EEG实验室，以实现高质量的数据采集。的 研究方法（血液采集除外）、方案和招募标准将反映其他 AMP-SCZ联盟的网站，以及获得的数据将公开共享。 这一补充很重要，因为非洲大陆内没有AMP-SCZ联合体。我们 公开分享的结果将促进对非政府组织数据的跨文化调查，考虑到 非洲血统和精神病风险基因种族异质性的精神病发病率。

ABSTRACT The parent study, “Clinical and Biomarker-Based Trajectories of Psychosis-Risk Populations in Kenya”, aims to build research capacity in Kenya, using state-of-the-art multimodal methods in order to map clinical outcomes in adolescents and young adults at clinical high risk (CHR) for developing schizophrenia (Aim 1). This involves building ERP/EEG infrastructure in Nairobi, by acquiring research grade acquisition equipment and software; MRI upgrades, including advanced diffusion and fMRI BOLD imaging capability; and elaborate research training. The study also collects multi-modal clinical and biomarkers over 24 months from 100 CHR participants including brain MRI, ERP/EEG, genetics, and cortisol, as well as baseline data from 50 healthy volunteers (Aim 2). Finally, the study would test the hypothesis that psychosis outcomes in Kenyan CHR populations will differ from the international CHR cohort by having fewer psychosis conversions and improved functioning (Aim 3). Our goal in this supplement request is to harmonize the research protocol and assessments with that of the 42 international sites within the ProNET and PRESCIENT networks, funded through the Accelerated Medicine Partnership – Schizophrenia (AMP-SCZ) consortium. Components of this supplement will allow for: 1) increasing the number of longitudinal timepoints to fifteen, 2) including healthy controls in longitudinal assessments, 3) including passive and active digital biomarker assessment, 4) incorporating AMP-SCZ assessment training and increased supervision, and 5) developing an ERP/EEG laboratory to enable high-quality data acquisition. The study methods (with the exception of blood collection), protocol and recruitment criteria will mirror that of other AMP-SCZ consortium sites, and data obtained will be publicly shared. This supplement is important as there are no AMP-SCZ consortium sites within the continent of Africa. Our publicly-shared results will facilitate cross-cultural investigations of CHR data, which is relevant considering the rates of psychosis reported in those with African ancestry and ethnic heterogeneity of psychosis risk genes.