Improving Health Care in Major Depressive Disorder: a New Prognostic Tool Based on Gene Environment and Neuroimaging Signatures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30,900
- 试验地点
- 1
- 主要终点
- The self-report depressive symptomatology
研究概览
简要总结
This project aims to improve the health care provided to people with major depressive disorder (MDD), a disease which is a top cause of disability worldwide. One of the main obstacles to a more effective health care in these patients is represented by clinical heterogeneity, which has not completely elucidated biological correlates. Using a large sample of people with MDD already recruited (n=29,400), the investigators develop a clustering algorithm based on genetic-environmental and brain imaging predictors aimed at identifying homogeneous MDD subgroups. The researchers will then link these subgroups with relevant health outcomes, such as disease recurrency and severity, well-being and functioning, risk of psychiatric and medical comorbidities (e.g. cardiovascular disorders). Replication in independent samples already recruited(n=1380) will prove the validity of the subgroups and expand their clinical characterization. The investigators will develop a classification tool to link the individual's characteristics to the relevant health outcomes and provide corresponding clinical recommendations. The prognostic support tool will be applied to newly recruited samples, feasibility and usefulness according to clinicians's opinion will be assessed (n=120, ongoing recruitment).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of depressive episode in Major Depressive Disorder (DSM-5);
- •at least one depressive episode preceding the current one;
- •aged between 18 and 65;
- •score of at least 8 on the Hamilton Depression Rating Scale (HDRS);
- •signature of the information form and declaration of informed consent;
- •elementary school certificate (as a minimum requirement for understanding the questions presented in the tests);
- •native Italian speaker (or bilingualism).
排除标准
- •diagnosis of bipolar disorder, cyclothymic disorder, schizophrenia and other psychotic spectrum disorders, neurodevelopmental disorders;
- •diagnosis of intellectual disability, epilepsy, neurodegenerative disorders;
- •disorders related to the use of drugs or alcohol in the last 6 months (except nicotine and caffeine);
- •pregnant or breastfeeding.
结局指标
主要结局
The self-report depressive symptomatology
时间窗: Assessment at the time of recruitment
Assessment of the depressive characteristics, using the Beck Depression Inventory (BDI) (Beck et al., 1961) with minimum-maximum values 0-39, higher scores mean a worse outcome, regarding the last 2 weeks.
The clinical evaluation of depressive symptomatology
时间窗: Assessment at the time of recruitment
Assessment of the presence of depressive status, Hamilton Depression Rating Scale (HDRS) (Hamilton, 1967) with minimum-maximum values 0-69, higher scores mean a worse outcome, regarding the current state.
The rate of cardiovascular and/or cardiometabolic diseases
时间窗: Assessment at the time of recruitment
Assessment of the presence/absence of lifetime and current cardiometabolic and/or cardiovascular diseases (e.g. diabetes, arterial hypertension, pulmonary arterial hypertension) based on extracted data from medical records and chart.
The depressive status
时间窗: Assessment at the time of recruitment
Assessment of the severity of disease using the Self-report Inventory Of Depressive Symptoms (IDS-SR) (Rush et al., 1996) with minimum-maximum values 0-116, higher scores mean a worse outcome, regarding the last week.
次要结局
- The quality of functioning and well-being(Assessment at the time of recruitment)
研究者
Benedetta Vai
Principal Investigator
Ospedale San Raffaele