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

NCT07346833 — Recruiting, 55 participants, Benha University

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

Registry	NCT07346833
Status	Recruiting
Study type	Observational
Enrollment	55 (Estimated)
Sponsor	Benha University (Other)
Conditions	Toxoplasmosis
Interventions	Circulating miRNA Expression and T. gondii Serology (Diagnostic test)
Dates	start 2025-11-20, primary completion 2026-02-01 (estimated), completion 2026-04-01 (estimated), first posted 2026-01-16, last updated 2026-01-16
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
T. gondii Seropositive Group		Diagnostic Test: Circulating miRNA Expression and T. gondii Serology	Women with diagnosed psychiatric disorders (Schizophrenia, MDD, or Bipolar Disorder) who test positive for anti-Toxoplasma IgG antibodies, indicating chronic infection.
T. gondii Seronegative Group		Diagnostic Test: Circulating miRNA Expression and T. gondii Serology	Women with the same diagnosed psychiatric disorders who test negative for anti-Toxoplasma IgG antibodies

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.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 50 Years

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.

+Locations (1)

Facility	City	Country	Status
Benha faculty of Medicine	Banhā, El Qalyoubia	Egypt	Recruiting

+Investigators

Basma Salem, MD, Principal investigator, Assistant Professor Clinical and Chemical Pathology. Faculty of Medicine, Benha University, Egypt
Dina Abd El hadi, MD, Principal investigator, Assistant Professor Medical Parasitology. Faculty of Medicine, Benha University, Egypt