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

Steve Reynolds

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06856161

FHREB 2024-143

Details and patient eligibility

About

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).

Enrollment: 500 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

DEP

Description:

Participants with suspected, new-onset, or established depression presenting to the psychiatric outpatient clinic at Royal Columbian Hospital.

PSY

Description:

Participants experiencing a first episode of psychosis or established schizophrenia presenting to an outpatient psychosis clinic at Royal Columbian Hospital.