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Exploring the Genetics of Schizophrenia in Manitoba (GENES-MB)

2026年6月12日 更新者:Kaarina Kowalec、University of Manitoba

Uncovering Schizophrenia Genetics Through Whole Genome Sequencing Across Manitoba

Schizophrenia is a serious mental illness that affects about 1 in 100 Canadians, shortens life expectancy, and places a large burden on individuals, families, and the healthcare system. Genetics are known to play a major role, but current research explains only part of the inherited risk because most studies have looked at only a small portion of the genome and have mainly focused on people outside Canada. This project will create the first large-scale Manitoba-based schizophrenia whole-genome sequencing database by studying 1,500 Manitobans with and without schizophrenia using both short-read and advanced long-read genome sequencing technologies. Researchers will combine genetic data with lifelong provincial health records to better understand rare genetic variants linked to schizophrenia and how genetic differences influence medication response, side effects, hospitalizations, and treatment outcomes. The study aims to fill important gaps in schizophrenia research in Canada, improve understanding of the disorder's biology, and support the development of more personalized and effective treatments for people living with schizophrenia.

研究概览

地位

尚未招聘

详细说明

This study aims to better understand the genetic factors involved in schizophrenia by collecting saliva samples from people with schizophrenia and individuals without psychiatric disorders across Manitoba. Researchers will use advanced genome sequencing to examine differences in genetic variation and identify genes that may contribute to schizophrenia. By combining genetic information with health and clinical data, this research will help improve our understanding of schizophrenia and support the development of more personalized approaches to treatment and care. People with schizophrenia (cases) will be recruited through participating psychosis clinics in Manitoba, review and sign a consent form, provide a saliva sample for genetic testing, allow researchers to use information already collected through the Manitoba Psychosis Registry and link it with health records. People without schizophrenia or other major psychiatric disorders (screened controls) will be screened to ensure they meet eligibility requirements, review and sign a consent form, complete questionnaires about their health, quality of life, and life experiences, provide a saliva sample for genetic testing, allow researchers to link their genetic information with health records. Objective: To understand how genes contribute to schizophrenia and psychosis by analyzing DNA samples from people with and without these conditions. Endpoints: Collection of DNA samples, identification of genetic differences associated with schizophrenia and psychosis, and understanding how these genetic factors relate to symptoms, health outcomes, and disease risk.

研究类型

观察性的

注册 (估计的)

1500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3E0T5
        • University of Manitoba
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

The schizophrenia study population will consist of Manitoba residents aged 18 years and older with a clinical diagnosis of schizophrenia according to DSM-5 criteria. Participants will be recruited from the MPR, including individuals receiving care through the Early Psychosis Prevention and Intervention Service (EPPIS), Schizophrenia Treatment and Education Program (STEP), Program of Assertive Community Treatment (PACT), and Assertive Community Treatment/Flexible Assertive Community Treatment (ACT/FACT) teams. Eligible participants must be enrolled in the MPR and provide informed consent to participate in the genetic sub-study. Participants will provide saliva samples for DNA extraction and whole genome sequencing, and their genetic data will be linked with clinical, questionnaire, and provincial administrative health data to support research on the genetic basis of schizophrenia and related health outcomes.

描述

Inclusion Criteria:

  • Individuals aged 18 years and older,
  • Reside in Manitoba,
  • Involved in the EPPIS, STEP, PACT, ACT/FACTT clinics,
  • Clinical diagnosis of schizophrenia using standard DSM-5 criteria,
  • Previously consented and enrolled in the MPR.

Exclusion Criteria:

  • There are no specific exclusion criteria beyond meeting the inclusion criteria or not providing informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Schizophrenia (cases)
The schizophrenia case group will consist of Manitoba residents aged 18 years and older who have a clinical diagnosis of schizophrenia based on standard DSM-5 criteria and who are already enrolled in the Manitoba Psychosis Registry (MPR). Participants will be recruited through psychosis-focused clinical programs in Manitoba, including the Early Psychosis Prevention and Intervention Service (EPPIS), Schizophrenia Treatment and Education Program (STEP), Program of Assertive Community Treatment (PACT), and Assertive Community Treatment/Flexible Assertive Community Treatment (ACT/FACT) teams. Cases will provide saliva samples for DNA extraction and whole genome sequencing, and genetic data will be linked with clinical information, questionnaire data, and provincial health administrative data to investigate the genetic basis of schizophrenia and related health outcomes.
Control (screened)
The screened control group will consist of Manitoba residents aged 40 years and older who have no known history of psychiatric disorders. Potential controls will be identified through the Manitoba Population Research Data Repository and recruited by invitation. Individuals will be excluded if they have had contact with a psychiatric specialist or have a history of antidepressant, lithium, mood stabilizer, or antipsychotic medication use. Participants will provide saliva samples for DNA extraction and whole genome sequencing, and their genetic data will be linked with provincial health administrative data. This group will serve as a comparison population for investigating genetic differences associated with schizophrenia.
Control (unscreened)
An unscreened control group of approximately 2,500 individuals from Manitoba and Saskatchewan will be included through the PrairieGen project. These participants were sequenced using the same whole genome sequencing technologies as the study participants and represent the general Prairie population. While no psychiatric screening or health administrative data linkage will be available for this group, they will provide a population-based genetic reference to improve statistical power and enhance the generalizability of genetic findings.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Genetic variation associated with schizophrenia
大体时间:through study completion, an average of 1 year
Identification of rare and common genetic variants through short-read and long-read whole genome sequencing. Comparison of genetic variant burden between schizophrenia cases and controls.
through study completion, an average of 1 year
Rare variant burden in schizophrenia
大体时间:through study completion, an average of 1 year
Evaluation of the frequency and distribution of rare genetic variants in individuals with schizophrenia compared with controls.
through study completion, an average of 1 year
Pharmacogenetic associations
大体时间:through study completion, an average of 1 year
Identification of genetic variants associated with antipsychotic treatment response and adverse drug reactions.
through study completion, an average of 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2031年4月1日

研究完成 (估计的)

2031年4月1日

研究注册日期

首次提交

2026年6月5日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • RITHIM #4915
  • PJT-206077 (其他赠款/资助编号:Canadian Institutes of Health Research)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

IPD may or may not be shared depending on whether the participant consents to allowing sharing.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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