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NCT Number: NCT07346833

Role of Circulating MicroRNAs in Differentiating 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.

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Key information

Conditions

Toxoplasmosis Coccidiosis Infections Parasitic Diseases Protozoan Infections

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Benha faculty of Medicine

Banhā, El Qalyoubia, 13511, Egypt

Location status: Recruiting

Location contact

Hesham Rashid, Professor

CONTACT

[email protected]

101 497 7666 ext. +20

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Heba Abo El Ela, MD

CONTACT

[email protected]

01062702236 ext. +2

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 16, 2026
Registry last updated: Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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