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临床试验/NCT05815225
NCT05815225招募中不适用

Neuroinflammation Markers in Subjects With Psychotic Symptoms

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Level of biomakers 2

研究概览

简要总结

The main objective of the study is to measure the plasma and intracellular levels of several neuroinflammation markers (including cytokines and chemokines) and the endocannabinoid system in subjects presenting psychotic symptoms, initially recruited in a Mental Health Hospitalization Unit, and in different stages of their disease.

To this end, we will evaluate and clinically characterize a cohort of patients who present active psychotic symptoms at the time of recruitment, and comparing it with a control group with similar sociodemographic characteristics. We will also compare our sample with a smaller sample previously recruited from patients with substance use and psychotic symptoms. Within our cohort of patients with psychotic symptomatology we will distinguish in turn affective psychoses from non-affective psychoses, on the one hand; and induced and non-induced psychosis by drug consumption, on the other. We will also classify patients based on whether they are experiencing the first episode of their illness or a relapse.

This is an observational, longitudinal and prospective study. 3 blood draws will be performed from the subjects included in the study: the first, in the first 48 hours of hospital admission; the second, in the 48 hours prior to discharge; and the third, 6 months after discharge. The rater team will be composed of senior psychiatrists and training psychiatrists. The sample will be composed of subjects with psychotic symptoms who come from the Mental Health Clinical Management Unit of the Regional University Hospital of Malaga. Each patient enrolled in this study will undergo a clinical evaluation (psychiatric diagnostic interview and psychometric scales). From the plasma and white blood cells of the blood sample, the biochemical levels of the inflammatory mediators will be determined. Demographic, clinical, and biochemical data will be assessed and analysed using statistical programmes.

详细描述

The main objective of the study is to measure the plasma and intracellular levels of several neuroinflammation markers (including cytokines and chemokines) and the endocannabinoid system in subjects presenting psychotic symptoms, initially recruited in a Mental Health Hospitalization Unit, and in different clinical and evolutive stages of their disease.

To this end, we will evaluate and clinically characterize a cohort of patients who present active psychotic symptoms at the time of recruitment, and comparing it with a control group with similar sociodemographic characteristics. We will also compare our sample with a smaller sample previously recruited from patients with substance use and induced psychotic symptoms. Within our cohort of patients with psychotic symptomatology we will distinguish in turn affective psychoses from non-affective psychoses, on the one hand; and induced and non-induced psychosis by drug consumption, on the other. We will also classify patients based on whether they are experiencing the first episode of their illness or a relapse.

This study has two parts. The first one is an observational, longitudinal and prospective study. 3 blood draws will be performed from the subjects included in the study (group A of participants, see below): the first, in the first 48 hours of hospital admission; the second, in the 48 hours prior to discharge; and the third, 6 months after discharge. The sample will be composed of subjects with psychotic symptoms who come from the Mental Health Clinical Management Unit of the Regional University Hospital of Malaga. Each patient enrolled in this study will undergo a clinical evaluation (psychiatric diagnostic interview and psychometric scales). Figure 1 represents this study.

The second one is a cross-sectional study in which we will compare measurements made in group A participants with a previously recruited sample of patients with substance-induced psychosis (group B, see below) and a sample of healthy, non-psychotic controls (group C, see below).

The rater team will be composed of senior psychiatrists and training psychiatrists. From the plasma and white blood cells of the blood sample, the biochemical levels of the inflammatory mediators will be determined. Demographic, clinical, and biochemical data will be assessed and analyzed using statistical programs.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

入选标准

  • Patients (men and women) with diagnostic criteria for psychotic episode, affective episode with psychotic symptoms, or substance-induced psychotic episode, according to DSM and ICD criteria.
  • Age from 18 to 65 years.
  • Informed consent.

排除标准

  • Severe cognitive alterations that do not allow the application of diagnostic instruments.
  • Infectious diseases [Laboratory prophylaxis (HIV, Hepatitis B, C)].
  • Not speaking the Spanish language fluently.
  • History of head trauma with loss of consciousness, stroke, or CNS disease.

结局指标

主要结局

Level of biomakers 2

时间窗: Week 1-8

Levels of endocannabinoids and neuroinflammation mediators (cytokines and chemokines) in subjects with active psychotic symptoms

Level of biomakers 1

时间窗: Week 1

Levels of endocannabinoids and neuroinflammation mediators (cytokines and chemokines) in subjects with active psychotic symptoms

Level of biomakers 3

时间窗: Week 22-26

Levels of endocannabinoids and neuroinflammation mediators (cytokines and chemokines) in subjects with active psychotic symptoms

Changes from Baseline level of biomarkers at 6 months

时间窗: Week 1 and Week 22-26

Changes from Baseline level of biomarkers at 6 months

次要结局

  • Rate of phenotype characteristics and clinical symptoms(Week 22-26)

研究者

发起方
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
申办方类型
Other
责任方
Sponsor

研究点 (1)

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