Actively Recruiting

Age: 19Years +
All Genders
ID06856161

A Novel Blood Test as a Differential Diagnosis and Drug Efficacy Biomarker in Mental Health

Led by Fraser Health · Updated on 2026-03-05

500

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

Sponsors

F

Fraser Health

Lead Sponsor

R

Royal Columbian Hospital Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether a new blood biomarker can help identify depression and schizophrenia in patients attending psychiatric clinics. The study aims to see if changes in this biomarker can distinguish depressed patients who respond to treatment from those who do not, and differentiate individuals having a first psychotic episode from those at risk of developing schizophrenia. This observational study involves up to 500 participants grouped by diagnosis into Depression (DEP) and Psychosis/Schizophrenia (PSY) arms. Participants will attend three study visits over six months, during which blood samples and standard mental health assessments will be collected. These visits will help researchers analyze the relationship between the biomarker characteristics and the mental health conditions. The study does not involve any treatments but focuses on monitoring and measuring the biomarker and clinical factors over time. During the study, participants will complete standardized mental health questionnaires at each visit, and researchers will collect blood samples to study the biomarker changes. The main outcomes measured include the relationship between depression or psychotic disorders and biomarker characteristics over the six-month period. Researchers will also explore how clinical and demographic factors relate to these biomarker changes. The total participation time spans about six months with three scheduled visits.

CONDITIONS

Brief Title

A Novel Blood Test as a Biomarker in Mental Health

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 years or older
  • Able to provide informed consent
  • Suspected, new onset, or established depression
  • First episode of psychosis or suspected/established schizophrenia
  • Likely able to complete standardized mental health questionnaires at each study visit
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Currently enrolled in any other research study involving drugs or devices that may affect mental health treatment outcomes
  • Currently declared on extended leave under British Columbia's Mental Health Act

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 6 months

Participants attend study visits to provide blood samples and complete mental health questionnaires to assess biomarker characteristics related to depression or psychotic disorders.

3 visits over 6 months

Trial Site Locations

Total: 1 location

1

Royal Columbian Hospital

New Westminster, British Columbia, Canada, V3L 3M2

Actively Recruiting

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Research Team

J

Jessica Wittmann

M

Marlena Ornowska

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Changes in Membrane Protein Clustering in Peripheral Lymphocytes in an Animal Model of Depression Parallel Those Observed in Naïve Depression Patients: Implications for the Development of Novel Biomarkers of Depression.

Raquel Romay-Tallon, Erin Kulhawy, Kyle J Brymer...

https://pubmed.ncbi.nlm.nih.gov/30374301

Serotonin 2A receptor clustering in peripheral lymphocytes is altered in major depression and may be a biomarker of therapeutic efficacy.

Tania Rivera-Baltanas, Jose Manuel Olivares, Jose Ramon Martinez-Villamarin...

https://pubmed.ncbi.nlm.nih.gov/24836087

Serotonin transporter clustering in blood lymphocytes as a putative biomarker of therapeutic efficacy in major depressive disorder.

Tania Rivera-Baltanas, Jose M Olivares, Maria Calado-Otero...

https://pubmed.ncbi.nlm.nih.gov/22257570

Serotonin transporter clustering in blood lymphocytes predicts the outcome on anhedonia scores in naïve depressive patients treated with antidepressant medication.

Tania Rivera-Baltanas, Roberto Carlos Agis-Balboa, Raquel Romay-Tallon...

https://pubmed.ncbi.nlm.nih.gov/26697099