Role of Circulating MicroRNAs in Differentiating Psychological Disorders Among Women With Chronic Toxoplasmosis

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

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 Overview

• Status: Recruiting
• Conditions: Toxoplasmosis
• Intervention / Treatment: Diagnostic test: Circulating miRNA Expression and T. gondii Serology

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Heba Abo El Ela, MD; Phone Number: +2 01062702236; Email: b.checked88@gmail.com

Study Locations

• Egypt
  • El Qalyoubia
    • Banhā, El Qalyoubia, Egypt, 13511
      • Recruiting
      • Benha Faculty of Medicine
      • Contact: Hesham Rashid, Professor; Phone Number: +20 101 497 7666; Email: b.checked88@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult women (aged 18 years and older) who have been clinically diagnosed with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder according to DSM-5 criteria. These patients are recruited from the psychiatric departments of Benha and Tanta Universities. Within this group, the population is divided into two cohorts: those with chronic toxoplasmosis (confirmed by the presence of anti-Toxoplasma IgG antibodies) and those without the infection. To ensure a specific focus on chronic cases, the study excludes patients with acute toxoplasmosis (IgM positive) or other unrelated psychiatric conditions. No healthy volunteers are included, as the research specifically aims to differentiate biomarkers among patients already experiencing psychological disturbances.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T. gondii Seropositive Group; Women with diagnosed psychiatric disorders (Schizophrenia, MDD, or Bipolar Disorder) who test positive for anti-Toxoplasma IgG antibodies, indicating chronic infection.	Diagnostic test: Circulating miRNA Expression and T. gondii Serology; Serology: ELISA testing to detect anti-Toxoplasma IgG (confirming chronic infection) and IgM (excluding acute infection). Genetic Analysis: Quantitative Reverse-transcriptase PCR (qRT-PCR) to measure the expression levels of a predetermined panel of plasma miRNAs. Psychiatric Evaluation: Clinical diagnosis according to DSM-5 criteria.
T. gondii Seronegative Group; Women with the same diagnosed psychiatric disorders who test negative for anti-Toxoplasma IgG antibodies	Diagnostic test: Circulating miRNA Expression and T. gondii Serology; Serology: ELISA testing to detect anti-Toxoplasma IgG (confirming chronic infection) and IgM (excluding acute infection). Genetic Analysis: Quantitative Reverse-transcriptase PCR (qRT-PCR) to measure the expression levels of a predetermined panel of plasma miRNAs. Psychiatric Evaluation: Clinical diagnosis according to DSM-5 criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy of Plasma miRNA Expression for Detecting Chronic Toxoplasmosis in Psychiatric Patients	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).	2-3 Months

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Basma Salem, MD, Assistant Professor Clinical and Chemical Pathology. Faculty of Medicine, Benha University, Egypt; Principal Investigator: Dina Abd El hadi, MD, Assistant Professor Medical Parasitology. Faculty of Medicine, Benha University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Protozoan Infections; Parasitic Diseases; Coccidiosis; Toxoplasmosis
• Other Study ID Numbers: RC 10.10.2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No