- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07656870
Exploring the Genetics of Schizophrenia in Manitoba (GENES-MB)
12. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Odhadovaný)
1500
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Kaarina Kowalec, PhD
- Telefonní číslo: 204-619-5711
- E-mail: kaarina.kowalec@umanitoba.ca
Studijní místa
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Manitoba
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Winnipeg, Manitoba, Kanada, R3E0T5
- University of Manitoba
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Kontakt:
- Danielle Perera, MSc
- Telefonní číslo: 204-789-3380
- E-mail: mb.pr@umanitoba.ca
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Genetic variation associated with schizophrenia
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. dubna 2031
Dokončení studie (Odhadovaný)
1. dubna 2031
Termíny zápisu do studia
První předloženo
5. června 2026
První předloženo, které splnilo kritéria kontroly kvality
12. června 2026
První zveřejněno (Aktuální)
18. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RITHIM #4915
- PJT-206077 (Jiné číslo grantu/financování: Canadian Institutes of Health Research)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NEROZHODNÝ
Popis plánu IPD
IPD may or may not be shared depending on whether the participant consents to allowing sharing.
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