A Novel Blood Test as a Biomarker in Mental Health (LEADING-MH)

March 3, 2026 updated by: Steve Reynolds, Fraser Health

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

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3M2
        • Recruiting
        • Royal Columbian Hospital
        • Contact:
        • Principal Investigator:
          • Steven Reynolds, MD, FRCPC
        • Sub-Investigator:
          • Elizabeth Rohrs, PhD, RRT
        • Sub-Investigator:
          • Siri Reinbold, MD, FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will enroll up to 500 adults (19 years and older) with suspected or diagnosed Major Depressive Disorder (MDD) or psychotic disorders, including schizophrenia, who are receiving care at psychiatric clinics at Royal Columbian Hospital (RCH) in New Westminster, Canada. The study population will be diverse in age, gender, ethnicity, and socioeconomic background, reflecting the demographics of RCH patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
DEP
Participants with suspected, new-onset, or established depression presenting to the psychiatric outpatient clinic at Royal Columbian Hospital.
PSY
Participants experiencing a first episode of psychosis or established schizophrenia presenting to an outpatient psychosis clinic at Royal Columbian Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between Depression and Biomarker Characteristics
Time Frame: 6 months from enrollment, across three study visits.
In the DEP arm, the study will evaluate the relationship between depression diagnosis, antidepressant responsiveness (assessed through changes in a standardized mental health questionnaire over time), and the characteristics of a novel blood peripheral biomarker.
6 months from enrollment, across three study visits.
Relationship between Psychotic Disorders and Biomarker Characteristics
Time Frame: 6 months from enrollment, across 3 study visits.
In the PSY arm, the study will evaluate the relationship between schizophrenia (defined as chronic, recurrent psychosis) and other psychotic disorders and the characteristics of a novel blood peripheral biomarker. A standardized clinical assessment tool will be used to support the diagnosis of schizophrenia.
6 months from enrollment, across 3 study visits.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Clinical-Demographic Factors and Biomarker Characteristics.
Time Frame: 6 months from enrollment, across 3 study visits.
In the DEP arm, the study will evaluate the relationship between a novel blood peripheral biomarker and various clinical and demographic factors. These factors include time, age, sex assigned at birth, and symptom severity related to suicidality, anxiety, substance use, and inflammation. Standardized mental health and clinical assessment tools will be used to quantify these variables.
6 months from enrollment, across 3 study visits.
Relationship between PSY arm Clinical-Demographic Factors and Biomarker Characteristics.
Time Frame: 6 months from enrollment, across 3 study visits.
In the PSY arm, the study will evaluate the relationship between the characteristics of a novel blood peripheral biomarker and various clinical and demographic factors. These factors include time, age, sex assigned at birth, and symptom severity related to psychosis, suicidality, anxiety, substance use, and inflammation. Standardized mental health and clinical assessment tools will be used to quantify these variables.
6 months from enrollment, across 3 study visits.
Association between Psychotic Disorders Pharmacological Treatment and Biomarker Characteristics
Time Frame: 6 months from enrollment, across 3 study visits.
In the PSY arm, the study will evaluate the relationship between changes over time in the characteristics of a novel blood peripheral biomarker and exposure to antipsychotics and other non-SSRI medications.
6 months from enrollment, across 3 study visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fraser Health

Collaborators

Royal Columbian Hospital Foundation

Investigators

  • Principal Investigator: Steven Reynolds, MD, FRCPC, Royal Columbian Hospital Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHREB 2024-143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Substance Use Disorders

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe