A Novel Blood Test As a Biomarker in Mental Health

Not yet recruiting

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

• Registration Number: NCT06856161
• Lead Sponsor: Steve Reynolds

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Study Start: 2025-03-15
• Primary Completion: 2026-03-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between Depression and Biomarker Characteristics	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.
Relationship between Psychotic Disorders and Biomarker Characteristics	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.

Secondary Outcome Measures

Name	Time	Method
Association between Clinical-Demographic Factors and Biomarker Characteristics.	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.
Relationship between PSY arm Clinical-Demographic Factors and Biomarker Characteristics.	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.
Association between Psychotic Disorders Pharmacological Treatment and Biomarker Characteristics	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.

Trial Locations

Locations (1)

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada