NCT Number: NCT06856161
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).
Interested in participating?
Request Info19 year and older
All sexes
Observational
New Westminster, British Columbia, V3L 3M2, Canada
Location status: Recruiting
Elizabeth Rohrs, PhD, RRT
SUB_INVESTIGATOR
Jessica Wittmann
CONTACT
Siri Reinbold, MD, FRCPC
SUB_INVESTIGATOR
Steven Reynolds, MD, FRCPC
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
I. Age 19+. II. Informed consent by participant
III. Any of the following situations:
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Jessica Wittmann
CONTACT
Marlena Ornowska
CONTACT
Fraser Health
Other
A Novel Blood Test as a Differential Diagnosis and Drug Efficacy Biomarker in Mental Health
Acronym: LEADING-MH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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