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A Novel Blood Test as a Biomarker in Mental Health

Study acronym: LEADING-MH
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Steve Reynolds to Fraser Healthv2 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 15, 2026 to Mar 15, 2027
    • Study completion date: Mar 15, 2026 to Aug 31, 2027
    • Start date changed from estimate of Mar 15, 2025 to Mar 25, 2025
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Fraser Health
6 trials monitored
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Anxiety
3,263 trials monitored
See 159 trials at risk
Depression
3,055 trials monitored
See 173 trials at risk
Schizophrenia
717 trials monitored
See 35 trials at risk
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).
Trial Details
NCT Number NCT06856161
Lead Sponsor Fraser Health
Collaborators: Royal Columbian Hospital Foundation
Conditions
(from sponsor)		 Depression - Major Depressive Disorder, Schizophenia Disorder, Psychosis, Mania (Neurotic), Alcohol Consumption, Anxiety Disorder (Panic Disorder or GAD), Substance Use Disorders, Alcohol Use Disorder
Related terms Alcohol Drinking, Alcoholism, Anxiety Disorders, Depression, Generalized Anxiety Disorder, Mania, Panic Disorder, Psychological Well-Being, Psychotic Disorders, Schizophrenia, Substance-Related Disorders
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov