Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Diagnosis of serious mental illness (SMI)
研究概览
简要总结
The primary study aims are to determine the clinical, behavioural and social predictors of SMI development in youth, and to investigate whether neuroimaging can distinguish youth who will develop SMI from those who will not.
The study's secondary aims are to examine the proportions of the cohort that make transitions between the different clinical stages of risk, and to determine the proportions that have poor outcomes, defined as ongoing or increased symptoms, secondary substance misuse, poor social or role functioning, i.e., non-participation in education, or employment, and new self-harm.
Investigators will study a cohort of 240 youth (aged 14-25, male and female) that includes youth with early mood symptoms or sub-threshold psychotic symptoms (symptomatic group; n=160), youth at risk due to a family history of a SMI (family high risk (FHR); n=40), and healthy controls (HC; n=40). From this cohort, clinical, social and cognitive data, as well as imaging data will be gathered to create a multi-layered "snapshot" of these individuals and provide full-level characterization. Investigators will use the full range of clinical and imaging data generated from this cohort to develop novel prediction algorithms incorporating key variables that predict the development of SMI.
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
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will understand and sign an informed consent (or assent for minors) document in English.
排除标准
- •meet criteria for current or lifetime Axis I bipolar or psychotic disorder (other Axis I disorders will not be exclusionary as they may be precursors to mood or psychotic disorders);
- •IQ < 70;
- •past or current history of a significant central nervous system disorder or serious medical disorder; and
- •current pharmacological treatment that would be considered as an adequate trial of treatment for a SMI.
结局指标
主要结局
Diagnosis of serious mental illness (SMI)
时间窗: 2 year
The Structured Clinical Interview for DSM-IV Disorders (SCID-1) will be used to determine the presence of any Axis I disorder
次要结局
- Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Scale of Prodromal Symptoms (SOPS)(2 year)
- Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Calgary Depression Scale for Schizophrenia (CDSS).(2 year)
- Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Young Mania Scale(2 year)
- Clinical symptoms on the Young Mania Scale.(2 year)
- Clinical symptoms on the CDSS.(2 year)
- Functioning(2 year)
- Structural brain changes(2 year)
- Clinical symptoms on the SOPS.(2 year)
- Structural Brain changes(2 year)
- Changes in cognition(2 year)
- Functional Brain changes(2 year)
研究者
Jean Addington, PhD
Professor
University of Calgary