A Novel Blood Test as a Biomarker in Mental Health

NCT06856161 | Recruiting

• 1 other identifier: FHREB 2024-143
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Depression - Major Depressive Disorder; Schizophenia Disorder; Psychosis; Mania (Neurotic); Alcohol Consumption; Anxiety Disorder (Panic Disorder or GAD); Substance Use Disorders; Alcohol Use Disorder

Keywords

mental health; biomarker; depression; schizophrenia; psychosis; SERT

Outcome Measures

Primary Outcomes (2)

• Relationship between Depression and Biomarker Characteristics

  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

  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 Outcomes (3)

• Association between Clinical-Demographic Factors and Biomarker Characteristics.

  6 months from enrollment, across 3 study visits.

• Relationship between PSY arm Clinical-Demographic Factors and Biomarker Characteristics.

  6 months from enrollment, across 3 study visits.

• Association between Psychotic Disorders Pharmacological Treatment and Biomarker Characteristics

  6 months from enrollment, across 3 study visits.

Study Arms (2)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• I. Age 19+. II. Informed consent by participant
• III. Any of the following situations:
• Suspected, new onset or established depression.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fraser Health: lead
• Royal Columbian Hospital Foundation: collaborator

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3M2, Canada

RECRUITING

Related Publications (51)

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MeSH Terms

Conditions

Psychotic Disorders; Mania; Alcohol Drinking; Anxiety Disorders; Panic Disorder; Generalized Anxiety Disorder; Substance-Related Disorders; Alcoholism; Psychological Well-Being; Depression; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drinking Behavior; Behavior; Chemically-Induced Disorders; Alcohol-Related Disorders; Personal Satisfaction; Behavioral Symptoms

Study Officials

• Steven Reynolds, MD, FRCPC

  Royal Columbian Hospital Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Wittmann

CONTACT

+1 (236) 332-6575; LeadingMH@fraserhealth.ca

Marlena Ornowska

CONTACT

+1 (236) 332-6575; LeadingMH@fraserhealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensivist, MD, FRCPC

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)