Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Total Enrollment
500 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-03-15
Study Completion Date
2026-03-15
Brief Summary
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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).
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Detailed Description
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Conditions
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Depression - Major Depressive Disorder
Schizophenia Disorder
Psychosis
Mania (Neurotic)
Alcohol Consumption
Anxiety Disorder (Panic Disorder or GAD)
Substance Use Disorders
Alcohol Use Disorder
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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DEP
Participants with suspected, new-onset, or established depression presenting to the psychiatric outpatient clinic at Royal Columbian Hospital.
No interventions assigned to this group
PSY
Participants experiencing a first episode of psychosis or established schizophrenia presenting to an outpatient psychosis clinic at Royal Columbian Hospital.
No interventions assigned to this group
Eligibility Criteria
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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.
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.
III. Currently declared on extended leave Under British Columbia's Mental Health Act.
Minimum Eligible Age
19 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Royal Columbian Hospital Foundation
OTHER
Sponsor Role
collaborator
Steve Reynolds
OTHER
Sponsor Role
lead
Responsible Party
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Steve Reynolds
MD, FRCPC
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Steven Reynolds, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Royal Columbian Hospital Foundation
Locations
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Royal Columbian Hospital
New Westminster, British Columbia, Canada
Site Status
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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FHREB 2024-143
Identifier Type: -
Identifier Source: org_study_id
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