Depression - Major Depressive DisorderLEADING-MHNCT06856161
A Novel Blood Test as a Biomarker in Mental Health
An observational study of Depression - Major Depressive Disorder and Schizophenia Disorder, run by Fraser Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Schizophenia Disorder, Psychosis
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 25 Mar 2025to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 19+. II. Informed consent by participant
- Any of the following situations:
- Suspected, new onset or established depression.
- 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.
Who cannot join
- Inability to provide informed consent. II. Currently enrolled in any other research study involving drugs or devices that may confound mental health treatment outcomes.
- Currently declared on extended leave Under British Columbia's Mental Health Act.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3M2
Jessica Wittmann, LeadingMH@fraserhealth.ca
Steven Reynolds, MD, FRCPC
About this study
Official title: A Novel Blood Test as a Differential Diagnosis and Drug Efficacy Biomarker in Mental Health
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, Anxiety Disorder (Panic Disorder or GAD)
- Keywords
- mental health, biomarker, depression, schizophrenia, psychosis, SERT
- Medical subject headings
- Psychotic Disorders, Mania, Alcohol Drinking, Anxiety Disorders, Panic Disorder, Generalized Anxiety Disorder, Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between Depression and Biomarker Characteristics
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.
Measured: 6 months from enrollment, across three study visits.
Relationship between Psychotic Disorders and Biomarker Characteristics
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.
Measured: 6 months from enrollment, across 3 study visits.
Secondary outcomes (3)
Association between Clinical-Demographic Factors and Biomarker Characteristics.
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.
Measured: 6 months from enrollment, across 3 study visits.
Relationship between PSY arm Clinical-Demographic Factors and Biomarker Characteristics.
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.
Measured: 6 months from enrollment, across 3 study visits.
Association between Psychotic Disorders Pharmacological Treatment and Biomarker Characteristics
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.
Measured: 6 months from enrollment, across 3 study visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start25 Mar 2025
- Primary completion15 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Columbian Hospital Foundation
- Responsible party
- Principal investigator, Steve Reynolds, Fraser Health
- Investigators
- Steven Reynolds, MD, FRCPC, Principal investigator, Royal Columbian Hospital Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856161
- Sponsor's protocol ID
- FHREB 2024-143
- Acronym
- LEADING-MH
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romay-Tallon R, Kulhawy E, Brymer KJ, Allen J, Rivera-Baltanas T, Olivares JM, Kalynchuk LE, Caruncho HJ. Changes in Membrane Protein Clustering in Peripheral Lymphocytes in an Animal Model of Depression Parallel Those Observed in Naive Depression Patients: Implications for the Development of Novel Biomarkers of Depression. Front Pharmacol. 2018 Oct 15;9:1149. doi: 10.3389/fphar.2018.01149. eCollection 2018.
PubMed 30374301Rodrigues-Amorim D, Rivera-Baltanas T, Lopez M, Spuch C, Olivares JM, Agis-Balboa RC. Schizophrenia: A review of potential biomarkers. J Psychiatr Res. 2017 Oct;93:37-49. doi: 10.1016/j.jpsychires.2017.05.009. Epub 2017 May 26.
PubMed 28578207Rivera-Baltanas T, Olivares JM, Martinez-Villamarin JR, Fenton EY, Kalynchuk LE, Caruncho HJ. Serotonin 2A receptor clustering in peripheral lymphocytes is altered in major depression and may be a biomarker of therapeutic efficacy. J Affect Disord. 2014 Jul;163:47-55. doi: 10.1016/j.jad.2014.03.011. Epub 2014 Apr 3.
PubMed 24836087Rivera-Baltanas T, Olivares JM, Calado-Otero M, Kalynchuk LE, Martinez-Villamarin JR, Caruncho HJ. Serotonin transporter clustering in blood lymphocytes as a putative biomarker of therapeutic efficacy in major depressive disorder. J Affect Disord. 2012 Mar;137(1-3):46-55. doi: 10.1016/j.jad.2011.12.041. Epub 2012 Jan 16.
PubMed 22257570Rivera-Baltanas T, Agis-Balboa RC, Romay-Tallon R, Kalynchuk LE, Olivares JM, Caruncho HJ. Serotonin transporter clustering in blood lymphocytes predicts the outcome on anhedonia scores in naive depressive patients treated with antidepressant medication. Ann Gen Psychiatry. 2015 Dec 21;14:45. doi: 10.1186/s12991-015-0085-8. eCollection 2015.
PubMed 26697099Rangaswamy T, Mangala R, Mohan G, Joseph J, John S. Intervention for first episode psychosis in India - The SCARF experience. Asian J Psychiatr. 2012 Mar;5(1):58-62. doi: 10.1016/j.ajp.2012.01.011. Epub 2012 Mar 3.
PubMed 26878950Peterson BS. Editorial: Biomarkers in precision medicine for mental illnesses. J Child Psychol Psychiatry. 2020 Dec;61(12):1279-1281. doi: 10.1111/jcpp.13357.
PubMed 33252151Orsolini L, Pompili S, Tempia Valenta S, Salvi V, Volpe U. C-Reactive Protein as a Biomarker for Major Depressive Disorder? Int J Mol Sci. 2022 Jan 30;23(3):1616. doi: 10.3390/ijms23031616.
PubMed 35163538Ormel J, Hollon SD, Kessler RC, Cuijpers P, Monroe SM. More treatment but no less depression: The treatment-prevalence paradox. Clin Psychol Rev. 2022 Feb;91:102111. doi: 10.1016/j.cpr.2021.102111. Epub 2021 Dec 11.
PubMed 34959153Obermeier M, Schennach-Wolff R, Meyer S, Moller HJ, Riedel M, Krause D, Seemuller F. Is the PANSS used correctly? a systematic review. BMC Psychiatry. 2011 Jul 18;11:113. doi: 10.1186/1471-244X-11-113.
PubMed 21767349National Collaborating Centre for Mental Health (UK). Psychosis and Schizophrenia in Adults: Treatment and Management: Updated Edition 2014. London: National Institute for Health and Care Excellence (UK); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK248060/
PubMed 25340235Murphy SE, Capitao LP, Giles SLC, Cowen PJ, Stringaris A, Harmer CJ. The knowns and unknowns of SSRI treatment in young people with depression and anxiety: efficacy, predictors, and mechanisms of action. Lancet Psychiatry. 2021 Sep;8(9):824-835. doi: 10.1016/S2215-0366(21)00154-1.
PubMed 34419187Munkholm K, Winkelbeiner S, Homan P. Individual response to antidepressants for depression in adults-a meta-analysis and simulation study. PLoS One. 2020 Aug 27;15(8):e0237950. doi: 10.1371/journal.pone.0237950. eCollection 2020.
PubMed 32853222Moreno-Agostino D, Wu YT, Daskalopoulou C, Hasan MT, Huisman M, Prina M. Global trends in the prevalence and incidence of depression:a systematic review and meta-analysis. J Affect Disord. 2021 Feb 15;281:235-243. doi: 10.1016/j.jad.2020.12.035. Epub 2020 Dec 9.
PubMed 33338841Meyer TD, Crist N, La Rosa N, Ye B, Soares JC, Bauer IE. Are existing self-ratings of acute manic symptoms in adults reliable and valid?-A systematic review. Bipolar Disord. 2020 Sep;22(6):558-568. doi: 10.1111/bdi.12906. Epub 2020 Apr 13.
PubMed 32232950
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Blood Test as a Differential Diagnosis and Drug Efficacy Biomarker in Mental Health
- ClinicalTrials.gov ID
- NCT06856161
- Acronym / sponsor ID
- LEADING-MH / FHREB 2024-143
- Conditions
- Depression - Major Depressive Disorder, Schizophenia Disorder, Psychosis, Mania (Neurotic), Alcohol Consumption, Anxiety Disorder (Panic Disorder or GAD)
- Keywords
- mental health, biomarker, depression, schizophrenia, psychosis, SERT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- Royal Columbian Hospital Foundation
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age 19+. II. Informed consent by participant
- Any of the following situations:
- Suspected, new onset or established depression.
- 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.
Key exclusion criteria (2 listed)
- Inability to provide informed consent. II. Currently enrolled in any other research study involving drugs or devices that may confound mental health treatment outcomes.
- Currently declared on extended leave Under British Columbia's Mental Health Act.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between Depression and Biomarker Characteristics
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.
Relationship between Psychotic Disorders and Biomarker Characteristics
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.
3 secondary outcomes
Association between Clinical-Demographic Factors and Biomarker Characteristics.
Time frame: 6 months from enrollment, across 3 study visits.
Relationship between PSY arm Clinical-Demographic Factors and Biomarker Characteristics.
Time frame: 6 months from enrollment, across 3 study visits.
Association between Psychotic Disorders Pharmacological Treatment and Biomarker Characteristics
Time frame: 6 months from enrollment, across 3 study visits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 30374301Romay-Tallon R, Kulhawy E, Brymer KJ, Allen J, Rivera-Baltanas T, Olivares JM, Kalynchuk LE, Caruncho HJ. Changes in Membrane Protein Clustering in Peripheral Lymphocytes in an Animal Model of Depression Parallel Those Observed in Naive Depression Patients: Implications for the Development of Novel Biomarkers of Depression. Front Pharmacol. 2018 Oct 15;9:1149. doi: 10.3389/fphar.2018.01149. eCollection 2018.
- Background: PubMed 28578207Rodrigues-Amorim D, Rivera-Baltanas T, Lopez M, Spuch C, Olivares JM, Agis-Balboa RC. Schizophrenia: A review of potential biomarkers. J Psychiatr Res. 2017 Oct;93:37-49. doi: 10.1016/j.jpsychires.2017.05.009. Epub 2017 May 26.
- Background: PubMed 24836087Rivera-Baltanas T, Olivares JM, Martinez-Villamarin JR, Fenton EY, Kalynchuk LE, Caruncho HJ. Serotonin 2A receptor clustering in peripheral lymphocytes is altered in major depression and may be a biomarker of therapeutic efficacy. J Affect Disord. 2014 Jul;163:47-55. doi: 10.1016/j.jad.2014.03.011. Epub 2014 Apr 3.
- Background: PubMed 22257570Rivera-Baltanas T, Olivares JM, Calado-Otero M, Kalynchuk LE, Martinez-Villamarin JR, Caruncho HJ. Serotonin transporter clustering in blood lymphocytes as a putative biomarker of therapeutic efficacy in major depressive disorder. J Affect Disord. 2012 Mar;137(1-3):46-55. doi: 10.1016/j.jad.2011.12.041. Epub 2012 Jan 16.
- Background: PubMed 26697099Rivera-Baltanas T, Agis-Balboa RC, Romay-Tallon R, Kalynchuk LE, Olivares JM, Caruncho HJ. Serotonin transporter clustering in blood lymphocytes predicts the outcome on anhedonia scores in naive depressive patients treated with antidepressant medication. Ann Gen Psychiatry. 2015 Dec 21;14:45. doi: 10.1186/s12991-015-0085-8. eCollection 2015.
- Background: PubMed 26878950Rangaswamy T, Mangala R, Mohan G, Joseph J, John S. Intervention for first episode psychosis in India - The SCARF experience. Asian J Psychiatr. 2012 Mar;5(1):58-62. doi: 10.1016/j.ajp.2012.01.011. Epub 2012 Mar 3.
- Background: PubMed 33252151Peterson BS. Editorial: Biomarkers in precision medicine for mental illnesses. J Child Psychol Psychiatry. 2020 Dec;61(12):1279-1281. doi: 10.1111/jcpp.13357.
- Background: PubMed 35163538Orsolini L, Pompili S, Tempia Valenta S, Salvi V, Volpe U. C-Reactive Protein as a Biomarker for Major Depressive Disorder? Int J Mol Sci. 2022 Jan 30;23(3):1616. doi: 10.3390/ijms23031616.
- Background: PubMed 34959153Ormel J, Hollon SD, Kessler RC, Cuijpers P, Monroe SM. More treatment but no less depression: The treatment-prevalence paradox. Clin Psychol Rev. 2022 Feb;91:102111. doi: 10.1016/j.cpr.2021.102111. Epub 2021 Dec 11.
- Background: PubMed 21767349Obermeier M, Schennach-Wolff R, Meyer S, Moller HJ, Riedel M, Krause D, Seemuller F. Is the PANSS used correctly? a systematic review. BMC Psychiatry. 2011 Jul 18;11:113. doi: 10.1186/1471-244X-11-113.
- Background: PubMed 25340235National Collaborating Centre for Mental Health (UK). Psychosis and Schizophrenia in Adults: Treatment and Management: Updated Edition 2014. London: National Institute for Health and Care Excellence (UK); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK248060/
- Background: PubMed 34419187Murphy SE, Capitao LP, Giles SLC, Cowen PJ, Stringaris A, Harmer CJ. The knowns and unknowns of SSRI treatment in young people with depression and anxiety: efficacy, predictors, and mechanisms of action. Lancet Psychiatry. 2021 Sep;8(9):824-835. doi: 10.1016/S2215-0366(21)00154-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Reynolds, MD, FRCPC principal investigator
Royal Columbian Hospital Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder and Schizophenia Disorder, run by Fraser Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Wittmann (+1 (236) 332-6575, LeadingMH@fraserhealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between Depression and Biomarker Characteristics (time frame: 6 months from enrollment, across three study visits.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06856161, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.