Accelerating Medicines Partnership® Schizophrenia Observational Study: Psychosis Risk Evaluation, Data Integration, and Computational Technologies -Data Processing, Analysis, and Coordination Center and Coordination Center
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,617
- 试验地点
- 42
- 主要终点
- Conversion to Psychosis
研究概览
简要总结
The Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) is a large international collaboration to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the testing of pharmacological interventions for CHR individuals in need. The goal is to accurately predict which individuals are likely to remit, experience an acute psychotic episode, or have intermediate outcomes that feature persistent attenuated psychotic and/or mood symptoms along with functional impairment. The prediction algorithms will have the potential to serve as early indicators of treatment efficacy in CHR persons.
The AMP SCZ research program is made up of the Psychosis Risk Evaluation, Data Integration, and Computational Technologies - Data Processing, Analysis and Coordination Center (PREDICT-DPACC) and two clinical research networks, the Psychosis-Risk Outcomes Network (ProNET) and the Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) networks. The two clinical research networks will recruit a large cohort of CHR young people aged 12-30 years (n=1,977) and healthy control (HC) participants (n=640) across 42 participating investigative sites from 13 countries. CHR participants will complete screening, baseline assessments and a battery of follow-up assessments across 18 - 24 months. HC participants will complete screening and baseline assessments and a subset (5 per site) will complete month 2, 12 and 24 visits.
详细描述
The Accelerating Medicines Partnership (AMP®) is a public-private partnership between the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and multiple public and private organizations. The goal of the AMP Schizophrenia (AMP SCZ) program, a multi-continent consortium, is to develop a deep biomarker-informed functional characterization and longitudinal clinical profiling of study participants at clinical high risk (CHR) for psychosis. The data will support the development of algorithms of clinical and biological measures to predict the trajectories and outcomes of CHR individuals to identify enriched CHR patient populations to enable proof of principle intervention studies for early intervention in schizophrenia. These tools will allow the assessment of biomarkers and outcome measures as early indicators of pharmacologic treatment efficacy. See the AMP SCZ website link for a detailed description of study goals (https://www.ampscz.org/about/goals/).
The Accelerating Medicines Partnership® Schizophrenia Observational Study: Psychosis Risk Evaluation, Data Integration, and Computational Technologies Data Processing, Analysis and Coordination Center (AMP SCZ® Observational Study: PREDICT-DPACC) based out of Brigham and Women's Hospital (BWH) and Mass General Brigham (MGB) is one of three research projects supported by the AMP SCZ program.
The AMP SCZ Observational Study: PREDICT-DPACC works with two Clinical High Risk (CHR) research networks (described below) to meet the following goals:
- Capture data from the research networks in a uniform manner.
- Build flexible infrastructure to accommodate multiple data types.
- Develop and refine pipelines that provide rapid data processing (in close to real-time) and quality assurance (QA) and quality control (QC).
- Provide data coordination, management, and monitoring of data.
- Develop powerful and robust stratification tools to identify & validate biomarkers and predict individual outcome trajectories.
- Assist in archiving data and making it publicly available in the NIMH Data Archive (NDA). Please see (https://nda.nih.gov/ampscz/).
- Disseminate information, including tools developed, to the general research community, and provide outreach to the community via a website.
MGB institutions do not provide or enroll participants for this study but serve as the AMP SCZ DPACC for two CHR Research Networks (RNs) where consent and all clinical testing and data collection occur. MGB is a data recipient only, not a data provider. The Mass General Brigham IRB is the IRB of record for the AMP SCZ® Observational Study: PREDICT-DPACC and the IRB status is exempt.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals between 12 and 30 years old;
- •Understand and sign an informed consent (or assent for minors) document;
- •Meet diagnostic criteria for CHR from the Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS (PSYCHS).
排除标准
- •Antipsychotic medication exposure equivalent to a total lifetime haloperidol dose of >50 mg or current antipsychotic medication at time of screening assessment;
- •Documented history of intellectual disability;
- •Past or current clinically relevant central nervous system disorder;
- •Traumatic brain injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument;
- •Current or past treated or untreated psychotic episode, as determined using the PSYCHS.
- •See also the AMP SCZ website link for a description of eligibility criteria (https://www.ampscz.org/participate/eligible/).
结局指标
主要结局
Conversion to Psychosis
时间窗: By 24 month follow-up.
Conversion to psychosis as defined by psychosis threshold criteria on the PSYCHS.
次要结局
- Remission(By 24 month follow-up.)
- Non-conversion/Non-remission(By 24 month follow-up.)
研究者
Martha E Shenton
Senior Scientist
Brigham and Women's Hospital