- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07656870
Exploring the Genetics of Schizophrenia in Manitoba (GENES-MB)
2026년 6월 12일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (추정된)
1500
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kaarina Kowalec, PhD
- 전화번호: 204-619-5711
- 이메일: kaarina.kowalec@umanitoba.ca
연구 장소
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3E0T5
- University of Manitoba
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연락하다:
- Danielle Perera, MSc
- 전화번호: 204-789-3380
- 이메일: mb.pr@umanitoba.ca
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Genetic variation associated with schizophrenia
기간: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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Rare variant burden in schizophrenia
기간: through study completion, an average of 1 year
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Evaluation of the frequency and distribution of rare genetic variants in individuals with schizophrenia compared with controls.
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through study completion, an average of 1 year
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Pharmacogenetic associations
기간: through study completion, an average of 1 year
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Identification of genetic variants associated with antipsychotic treatment response and adverse drug reactions.
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through study completion, an average of 1 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2031년 4월 1일
연구 완료 (추정된)
2031년 4월 1일
연구 등록 날짜
최초 제출
2026년 6월 5일
QC 기준을 충족하는 최초 제출
2026년 6월 12일
처음 게시됨 (실제)
2026년 6월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 12일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RITHIM #4915
- PJT-206077 (기타 보조금/기금 번호: Canadian Institutes of Health Research)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
IPD may or may not be shared depending on whether the participant consents to allowing sharing.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .