Skip to main content
Clinical Trials/NCT07346833
NCT07346833RecruitingNot Applicable

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

Benha University1 site in 1 country55 target enrollmentStarted: November 20, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
55
Locations
1
Primary Endpoint
Diagnostic Accuracy of Plasma miRNA Expression for Detecting Chronic Toxoplasmosis in Psychiatric Patients

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Benha University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heba M. Aboelela

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

Benha University

Study Sites (1)

Loading locations...

Similar Trials