Clinical Trial

A Novel Blood Test as a Biomarker in Mental Health

Study acronym: LEADING-MH
Recruiting
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Summary
This longitudinal, observational study aims to assess whether the characteristics of a novel blood peripheral biomarker can serve as indicators for depression and schizophrenia in patients at the Royal Columbian Hospital Psychiatric Clinics. The study will evaluate whether changes in these biomarker characteristics can help distinguish between depressed patients who do or do not respond to treatment and between individuals experiencing a single psychotic episode and those at risk of progressing to schizophrenia. To achieve this, blood samples and standardized mental health assessments will be collected across three study visits from up to 500 participants, grouped into two study arms based on their diagnosis: Depression (DEP) or Psychosis/Schizophrenia (PSY).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-26.
Status change: Not Yet Recruiting → Recruiting 2026-03-03
Trial Details
NCT Number NCT06856161
Lead Sponsor Fraser Health
Collaborators: Royal Columbian Hospital Foundation
Conditions Depression - Major Depressive Disorder, Schizophenia Disorder, Psychosis, Mania (Neurotic), Alcohol Consumption, Anxiety Disorder (Panic Disorder or GAD), Substance Use Disorders, Alcohol Use Disorder
Enrollment 500 participants
Start Date 2025-03-25
Primary Completion 2027-03-15 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-05