跳至主要内容
临床试验/NCT07346833
NCT07346833招募中不适用

Deciphering The Role of Circulating MicroRNAs To Differentiate Psychological Disorders Among Women With Chronic Toxoplasmosis

Benha University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年11月20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
55
试验地点
1
主要终点
Diagnostic Accuracy of Plasma miRNA Expression for Detecting Chronic Toxoplasmosis in Psychiatric Patients

研究概览

简要总结

Chronic Toxoplasma gondii (T. gondii) infection is a widespread condition that can negatively affect brain function and is considered a risk factor for various psychiatric conditions, including depression and schizophrenia. This prospective observational study aims to investigate the expression levels of specific circulating microRNAs (miRNAs) in women diagnosed with schizophrenia, major depressive disorder, or bipolar disorder who also have chronic toxoplasmosis. By comparing these levels to patients without the infection, the study seeks to determine if these miRNAs can serve as biological markers to help differentiate between specific psychological disorders and identify the impact of chronic toxoplasmosis on mental health.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Confirmed psychiatric diagnosis of Schizophrenia (SCZ), Major Depressive Disorder (MDD), or Bipolar Disorder (BD) according to DSM-5 criteria.
  • Seronegative for T. gondii IgM (to ensure infection is not in the acute phase).
  • Signed informed consent.

排除标准

  • Psychiatric disorders other than Schizophrenia, MDD, and Bipolar Disorder.
  • Seropositive for T. gondii IgM (indicating acute infection).
  • Refusal to participate.

结局指标

主要结局

Diagnostic Accuracy of Plasma miRNA Expression for Detecting Chronic Toxoplasmosis in Psychiatric Patients

时间窗: 2-3 Months

The Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) used to determine the diagnostic performance of circulating microRNA fold-change (measured by qRT-PCR) in discriminating between patients with and without chronic T. gondii infection (confirmed by anti-Toxoplasma IgG ELISA).

次要结局

未报告次要终点

研究者

发起方
Benha University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba M. Aboelela

Assistant Professor of Medical Parasitology, Faculty of Medicine, Benha University, Egypt

Benha University

研究点 (1)

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