Recruiting

Observational Study

Sponsor:

Fraser Health

Code:

NCT06856161

Conditions

Depression - Major Depressive Disorder

Schizophenia Disorder

Psychosis

Mania (Neurotic)

Alcohol Consumption

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06856161

Start date

Mar 25, 2025

Status verified date

Feb, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Relationship between Depression and Biomarker Characteristics [ Time Frame: 6 months from enrollment, across three study visits. ]
  • Relationship between Psychotic Disorders and Biomarker Characteristics [ Time Frame: 6 months from enrollment, across 3 study visits. ]

Central Contacts and Locations

Central contacts

Jessica Wittmann

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

Marlena Ornowska

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

Locations

Royal Columbian Hospital

Recruiting

New Westminster, British Columbia, Canada, V3L 3M2

Contacts

Jessica Wittmann

LeadingMH@fraserhealth.ca

Principal Investigator:

Steven Reynolds, MD, FRCPC

More Information

Sponsor

Fraser Health

Last update posted

Mar 5, 2026

Last verified

Feb, 2026

Keywords

  • mental health
  • biomarker
  • depression
  • schizophrenia
  • psychosis
  • SERT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fraser Health on 2026-03-05.