New blood test to help identify and track depression and early schizophrenia
A Novel Blood Test as a Differential Diagnosis and Drug Efficacy Biomarker in Mental Health
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Fraser Health Academic / other |
| Locations | 1 site (New Westminster, British Columbia) |
| Trial ID | NCT06856161 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New Westminster, British Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.