New blood test to help identify and track depression and early schizophrenia
Official title: A Novel Blood Test as a Differential Diagnosis and Drug Efficacy Biomarker in Mental Health
Run by Fraser Health · NCT06856161 · Data updated 2026-11-12
This project will try a new blood test to see if it can identify and track depression or early schizophrenia in adults receiving psychiatric care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Fraser Health Academic / other |
| Locations | 1 site (New Westminster, British Columbia) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | March 15, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT06856161 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19 or older with suspected, new, or established depression, or with first-episode psychosis or suspected/established schizophrenia who can give informed consent and complete questionnaires.
✕Probably not a fit
People who cannot provide informed consent, are currently declared on extended leave under British Columbia's Mental Health Act, are enrolled in conflicting drug/device studies, or who do not have depression or psychosis/schizophrenia are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This longitudinal observational project will collect blood samples and standardized mental-health assessments at three visits from up to 500 adults seen at the Royal Columbian Hospital psychiatric clinics. Participants will be grouped into two arms based on diagnosis: a Depression arm and a Psychosis/Schizophrenia arm. Researchers will measure characteristics of a novel peripheral blood biomarker and compare changes over time to treatment response in depression and to clinical progression in psychosis. The analysis will test whether biomarker patterns distinguish treatment responders from non-responders and single psychotic episodes from those at higher risk of developing schizophrenia.
Why it matters
Potential benefit: If successful, the test could help clinicians identify who is likely to respond to depression treatments and detect early signs of progression to schizophrenia, enabling earlier or more personalized care.
How similar studies have gone: Early research has shown some blood-based markers can correlate with mood and psychotic states, but robust large-scale longitudinal validation for clinical use is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: I. Age 19+. II. Informed consent by participant III. Any of the following situations: 1. Suspected, new onset or established depression. 2. First episode of psychosis or suspected/established schizophrenia. IV. In the opinion of the Investigator, the participant will likely be able to complete the standardized mental health questionnaires administered in each study visit. Exclusion Criteria: I. Inability to provide informed consent. II. Currently enrolled in any other research study involving drugs or devices that may confound mental health treatment outcomes. III. Currently declared on extended leave Under British Columbia's Mental Health Act.
Where it's running
-
Royal Columbian Hospital
New Westminster, British Columbia, Canada Recruiting
Study contacts
- Principal investigator: Steven Reynolds, MD, FRCPC — Royal Columbian Hospital Foundation
- Study coordinator: Jessica Wittmann
- Email: LeadingMH@fraserhealth.ca
- Phone: +1 (236) 332-6575
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.