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

12 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

1500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E0T5
        • University of Manitoba
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Genetic variation associated with schizophrenia
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Manitoba

Collaborateurs

Canadian Institutes of Health Research (CIHR)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 avril 2031

Achèvement de l'étude (Estimé)

1 avril 2031

Dates d'inscription aux études

Première soumission

5 juin 2026

Première soumission répondant aux critères de contrôle qualité

12 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RITHIM #4915
  • PJT-206077 (Autre subvention/numéro de financement: Canadian Institutes of Health Research)

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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