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

NCT07346833 | Recruiting

• 1 other identifier: RC 10.10.2025
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxoplasmosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Circulating miRNA Expression and T. gondii Serology DIAGNOSTIC_TEST

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; T. gondii Seropositive Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha faculty of Medicine

Banhā, El Qalyoubia, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Toxoplasmosis

Condition Hierarchy (Ancestors)

Coccidiosis; Protozoan Infections; Parasitic Diseases; Infections

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba Abo El Ela, MD

CONTACT

01062702236; b.checked88@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medical Parasitology, Faculty of Medicine, Benha University, Egypt

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 16, 2026
• Study Start: November 20, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

EG (1)