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| Name | Class |
|---|---|
| Royal Columbian Hospital Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 months from enrollment, across 3 study visits. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Wittmann | Contact | +1 (236) 332-6575 | LeadingMH@fraserhealth.ca | |
| Marlena Ornowska | Contact | +1 (236) 332-6575 | LeadingMH@fraserhealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Steven Reynolds, MD, FRCPC | Royal Columbian Hospital Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Columbian Hospital | Recruiting | New Westminster | British Columbia | V3L 3M2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30374301 | Background | 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. | |
| 28578207 |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D000087122 | Mania |
| D000428 | Alcohol Drinking |
| D001008 | Anxiety Disorders |
| D016584 | Panic Disorder |
| D000098647 | Generalized Anxiety Disorder |
| D019966 | Substance-Related Disorders |
| D000437 | Alcoholism |
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| 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. | 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. | 6 months from enrollment, across 3 study visits. |
| Background |
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| 24836087 | Background | Rivera-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. |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D010549 | Personal Satisfaction |
| D001526 | Behavioral Symptoms |