NCT05547711尚未招募不适用
Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting
Julia Eder1 个研究点 分布在 1 个国家目标入组 950 人开始时间: 2022年10月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 950
- 试验地点
- 1
- 主要终点
- Changes in MADRS
研究概览
简要总结
The POKAL-PSY project is a study that monitors participants for five years. The goal of the study is to identify distinguishable subtypes of depression on the basis of biomarkers and to gain insight into their prognostic significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(PHQ>8) if depressed
- •Subjects of any sex aged between 18-70
- •Sufficient ability to speak and understand the german language
- •Ability to understand and sign the informed consent form
排除标准
- •Cognitive impairment that interferes with reliable completion of questionnaires or answering questions
- •Presence of manic episode, bipolar disorder, Schizophrenia or schizoaffective disorder (as well as other diseases in the F2 domain in the ICD), active eating disorder, active drug or alcohol dependence syndrome
- •Presence of uncontrolled systemic disease (e.g. autoimmune disease), uncontrolles somatic (other than metabolic or cardiovascular)/ neurologic diseases, current or recent (last month) physical trauma
- •Patient with acute suicidal ideation
- •known deficiency of alpha-1-antitrypsin
- •pregnant or lactating women
研究组 & 干预措施
Patients with depression
Active Comparator
干预措施: drawing blood (Diagnostic Test)
Healthy controls
Active Comparator
干预措施: drawing blood (Diagnostic Test)
结局指标
主要结局
Changes in MADRS
时间窗: 4 Weeks
Alpha-1-Antitrypsin
时间窗: 1 year
Changes in GAF
时间窗: 4 Weeks
IGF-1
时间窗: 1 year
weight
时间窗: 1 year
次要结局
- Changes in GAF(5 years)
- Changes in MADRS(5 years)
- alpha-1-Antitrypsin(5 years)
- IGF-1(5 years)
- weight(5 years)
研究者
Julia Eder
Associate Physician
LMU Klinikum
研究点 (1)
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