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NCT Number: NCT07656870

Exploring the Genetics of Schizophrenia in 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.

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Key information

Conditions

Schizophrenia Healthy (Controls) Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Genetic variation associated with schizophrenia

    Time frame: 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.

  2. Rare variant burden in schizophrenia

    Time frame: 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.

  3. Pharmacogenetic associations

    Time frame: through study completion, an average of 1 year

    Identification of genetic variants associated with antipsychotic treatment response and adverse drug reactions.

Study contacts

Contact information is provided by the study sponsor or research team.

Kaarina Kowalec, PhD

CONTACT

[email protected]

204-619-5711

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Uncovering Schizophrenia Genetics Through Whole Genome Sequencing Across Manitoba

Acronym: GENES-MB

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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