SchizophreniaGENES-MBNCT07656870
Exploring the Genetics of Schizophrenia in Manitoba
An observational study of Schizophrenia and Healthy (Controls), run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Healthy (Controls)
- How many people
- 1,500 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2026to Apr 2031
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- There are no specific exclusion criteria beyond meeting the inclusion criteria or not providing informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Manitoba
Winnipeg, Manitoba, R3E0T5
Danielle Perera, MSc, 204-789-3380, mb.pr@umanitoba.ca
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Schizophrenia, Healthy (Controls)
- Keywords
- schizophrenia, genetics, saliva, genome, sequencing
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Pharmacogenetic associations
Identification of genetic variants associated with antipsychotic treatment response and adverse drug reactions.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Kaarina Kowalec, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656870
- Sponsor's protocol ID
- RITHIM #4915
- Other IDs
- PJT-206077
- Acronym
- GENES-MB
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may or may not be shared depending on whether the participant consents to allowing sharing.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncovering Schizophrenia Genetics Through Whole Genome Sequencing Across Manitoba
- ClinicalTrials.gov ID
- NCT07656870
- Acronym / sponsor ID
- GENES-MB / RITHIM #4915
- Conditions
- Schizophrenia, Healthy (Controls)
- Keywords
- schizophrenia, genetics, saliva, genome, sequencing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria beyond meeting the inclusion criteria or not providing informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided. IPD may or may not be shared depending on whether the participant consents to allowing sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Healthy (Controls), run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaarina Kowalec, PhD (204-619-5711, kaarina.kowalec@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic variation associated with schizophrenia (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.