A Novel Blood Test as a Differential Diagnosis and Drug Efficacy Biomarker in Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Relationship between Depression and Biomarker Characteristics
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I. Age 19+. II. Informed consent by participant
- •III. 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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Relationship between Depression and Biomarker Characteristics
时间窗: 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
时间窗: 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.
次要结局
- Association between Clinical-Demographic Factors and Biomarker Characteristics.(6 months from enrollment, across 3 study visits.)
- Relationship between PSY arm Clinical-Demographic Factors and Biomarker Characteristics.(6 months from enrollment, across 3 study visits.)
- Association between Psychotic Disorders Pharmacological Treatment and Biomarker Characteristics(6 months from enrollment, across 3 study visits.)
研究者
Steve Reynolds
Intensivist, MD, FRCPC
Fraser Health