Clinical trial NCT06856161: A Novel Blood Test as a Biomarker in Mental Health
Official title: A Novel Blood Test as a Differential Diagnosis and Drug Efficacy Biomarker in Mental Health
Study type: OBSERVATIONAL
Overall status: 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
Keywords: mental health
biomarker
depression
schizophrenia
psychosis
SERT
Lead sponsor: Fraser Health
Sponsor class: OTHER
Collaborators: name: Royal Columbian Hospital Foundation
First posted: 2025-03-04
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Relationship between Depression and Biomarker Characteristics
timeFrame: 6 months from enrollment, across three study visits.
measure: Relationship between Psychotic Disorders and Biomarker Characteristics
timeFrame: 6 months from enrollment, across 3 study visits.
Secondary outcomes:
measure: Association between Clinical-Demographic Factors and Biomarker Characteristics.
timeFrame: 6 months from enrollment, across 3 study visits.
measure: Relationship between PSY arm Clinical-Demographic Factors and Biomarker Characteristics.
timeFrame: 6 months from enrollment, across 3 study visits.
measure: Association between Psychotic Disorders Pharmacological Treatment and Biomarker Characteristics
timeFrame: 6 months from enrollment, across 3 study visits.
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Royal Columbian Hospital Foundation
name: Steven Reynolds, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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