P4D - Personalized, Predictive, Precise & Preventive Medicine for Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Remission after 7 weeks of treatment
研究概览
简要总结
Depressive disorders are among the most common psychiatric disorders. However, this disorder is multifaceted, as are its etiological factors, and is not yet fully understood. Within the framework of the P4D study, 1000 patients with depression will be comprehensively examined. In addition to the recording of psychological factors by means of questionnaires and third-party assessments, imaging and electrophysiological procedures (functional and structural MRI, EEG) are used to assess brain structure and function. In addition, blood is drawn from the subjects to analyze these samples for various biological markers (e.g., genetics). Drug level measurements are also performed.
The goal is to perform an in-depth characterization (phenotyping) of individuals with a depressive disorder. These findings could be used to individualize and improve therapy for depressive disorders.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDD: ICD-10: F32.1-3, F33.1-3 first or recurrent depressive episode (confirmed by MINI-DIPS) and/or PDD: F34.1
- •Symptom severity: Moderate to severe (MADRS ≥ 20).
- •First depressive episode before 50 years of age
- •Signed informed consent form
- •Capacity to consent
排除标准
- •Acute Suicidality
- •Placement according to state law (e.g. §16/17 Nds. PsychKG)
- •The following diagnoses in the life course: Dementia, schizophrenia, schizoaffective disorder, bipolar disorder, substance dependence with currently necessary detoxification
- •Concurrent participation in other clinical trials that are not being conducted within the framework of the P4D project
结局指标
主要结局
Remission after 7 weeks of treatment
时间窗: Baseline and Follow-up (Week 7)
The Montgomery-Asberg-Depression-Scale (MADRS) is used to measure the severity of depressive symptoms. A score lower 7 is the cut-off.
次要结局
- Recording of psychometric changes in the clinical course of treatment(Baseline and Follow-up (Week 7))
- Frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment)(Follow-up (Week 7))
- Treatment/study dropout rates(Drop-out rates are collected throughout the data collection period, over two years. Starting at study enrollment of the first subject until complete completion of the last subject.)
- Attitudes (acceptance, fears, and prejudices) regarding biomarker-guided examinations and technical procedures among the population(The survey will be conducted over a 2-week period in late August / early September 2023.)
- Patient-doctor relationship(Baseline and Follow-up (Week 7))