Synapsing's Multinational Sociodemographic Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,310
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
This is a prospective observational study to identify sociodemographic factors that predict mental health outcomes in the European population and provide evidence linking common, modifiable sociodemographic risk factors for psychiatric symptoms with biological changes in patients suffering from a mental disorder (MD) or a neurodegenerative disease (ND).
详细描述
Sociodemographic studies in mental disorder (MD) and neurodegenerative diseases (ND). Sociodemographic factors increase the likelihood of developing an MD and contribute to poorer outcomes. There is less research on socioeconomic differences in ND, but also low socioeconomic status is also associated with dementia risk and early onset dementia. Substantial gaps remain in understanding the social and biological mechanisms underlying these disparities. Effective public health interventions to reduce the burden of these disorders are currently lacking.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age>18 and donation of blood,
- •full clinical and psychological assessment
- •Available neuroimaging is optional as not all patients are suitable.
- •Age and sex-matched unaffected volunteers without a MD or ND diagnosis are used as controls.
- •Unaffected controls are usually spouses or children of patients that are informed about our studies at each clinical site.
排除标准
- •Lack of neuropsychological data,
- •anticoagulant treatment such as acenocoumarol, heparin, warfarin, dabigatran, rivaroxaban, apixaban, drug abuse in the last year,
- •medical history of cancer affecting the central nervous system that has not been in complete remission for 5 years or longer,
- •the patient has received potentially neurotoxic chemotherapy and/or patient has received cranial radiotherapy.
- •Clinical diagnosis of Alzheimer's disease where pathophysiological markers (measured in CSF or plasma) are inconsistent with Alzheimer's disease pathophysiology.
- •Cognitively healthy volunteers where pathophysiological markers (measured in CSF or plasma) are consistent with Alzheimer's disease or other neurodegenerative pathophysiology.
研究组 & 干预措施
Unaffected controls
No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease
Schizophrenia
Clinical diagnosis of schizophrenia
Dementia with Lewy bodies
Clinical diagnosis of dementia with Lewy bodies
major depressive disorder
Clinical diagnosis of major depressive disorder
Bipolar disorder
Clinical diagnosis of type I + II Bipolar disorder
Parkinson's disease
Clinical diagnosis of Parkinson's disease
Alzheimer's disease
Clinical diagnosis of Alzheimer's disease
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: 2-months after enrollment
Total score on the Hamilton Depression Rating Scale
Boston Naming Test
时间窗: 2-months after enrollment
Total score on the Boston Naming Test
Health behaviour
时间窗: 2-months after enrollment
Total score on the Health behaviour section of the sociodemographic survey
Diagnosis
时间窗: 2-months after enrollment
Primary diagnosis following evaluation by clinician and neuropsychologist or information relating to a previous or current MD/ND diagnosis or mental health issue (Anxiety disorders, behavioural and emotional disorder in children, bipolar affective disorders, depression, dissociation and dissociative disorders, eating disorders, obsessive compulsive disorder, paranoia, post-traumatic stress disorder or psychosis).
Perceived Wellbeing and Mental Health
时间窗: 2-months after enrollment
Total Score on the Perceived Wellbeing and Mental Health section of the survey
Social support
时间窗: 2-months after enrolment
Total score on the Social support section of the sociodemographic survey
Socioeconomic background
时间窗: 2-months after enrollment
Total score on the Socioeconomic background section of the sociodemographic survey
次要结局
- Structural brain changes(2 months after enrollment)
- Synaptic biomarker(Blood extracted 2-months after enrollment)