Exploring the Genetics of Schizophrenia in Manitoba

NCT07656870 | Not Yet Recruiting

• 2 other identifiers: RITHIM #4915PJT-206077
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Healthy (Controls)

Keywords

schizophrenia; genetics; saliva; genome; sequencing

Outcome Measures

Primary Outcomes (3)

• Genetic variation associated with schizophrenia

  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

  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

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

  through study completion, an average of 1 year

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E0T5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples will be collected from participants and retained for genetic research. DNA will be extracted from the saliva samples and used for whole genome sequencing and other genetic analyses related to schizophrenia, psychosis, and associated health outcomes. Remaining saliva samples and extracted DNA may be stored for future ethically approved research related to mental health and genetic factors contributing to psychotic disorders.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Kaarina Kowalec, PhD

CONTACT

204-619-5711; kaarina.kowalec@umanitoba.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

CA (1)