DRKS00034820尚未招募不适用
Clinical Deep Phenotyping of Treatment Response in Schizophrenia (CDP-STAR) Study - CDP-STAR
Klinik für Psychiatrie und Psychotherapie der LMU München0 个研究点目标入组 352 人开始时间: 2024年8月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 352
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 65 Years(—)
- 性别
- All
入选标准
- •The following inclusion criteria will apply:
- •- Obligatory participation to Munich Mental Health Biobank (Project number: 18-716);
- •- Diagnosis of schizophrenia-spectrum disorders, based on DSM-V, validated with the M.I.N.I. interview;
- •- Age: =18 years and = 65 years;
- •- Ability to participate in the extensive phenotyping of the CDP-STAR study;
- •- Ability to provide informed consent alone or, if necessary for patients who have a legal guardian for the task area health”, together with the patients and the respective legal guardian. The legal guardians can be informed and will also sign the consent form or give verbal consent after being informed by the study physician. Signatures by scan or fax will also be accepted;
- •- The ability to provide informed consent of patients with acute psychosis will be validated by a study-independent physician.
排除标准
- •The following exclusion criteria will apply:
- •- Patients with a primary psychiatric diagnosis other than defined above;
- •- Age: < 18 years and > 65 years;
- •- Patients who are not suitable for the study in the opinion of the investigator;
- •- Patients with acute danger to self and others (e.g. acute suicidality);
- •- Coercive treatment or forced placement in a psychiatric hospital at the time of study inclusion;
- •- Patients with a relevant comorbidity of the central nervous system (i.e. dementia, multiple sclerosis, epilepsy) or organic psychosis/affective disorder;
- •- Patients that are not able to provide informed consent;
- •- Contraindications for a cranial magnetic resonance imaging (MRI) such as pacemaker, ferromagnetic implants, or insulin pumps (applies only for the MRI assessment);
- •- For the subgroup of participants, on whom DCE-MRI will be performed, contraindications for a cranial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI): acute kidney failure (GFR < 30 ml/min or serum-creatinine > 130 µmol/l) or previous allergy/intolerance to a Gadolinium contrast medium or participants with known impaired kidney function, known metabolic alkalosis and hypokalemia, COPD or heart failure will not be included in the study (only applies for the participants, who receive a DCE-MRI assessment).
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