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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07346833
Enrollment
55
Registered
2026-01-16
Start date
2025-11-20
Completion date
2026-04-01
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Toxoplasmosis

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.

Interventions

DIAGNOSTIC_TESTCirculating 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.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy of Plasma miRNA Expression for Detecting Chronic Toxoplasmosis in Psychiatric Patients2-3 MonthsThe 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).

Countries

Egypt

Contacts

CONTACTHeba Abo El Ela, MD
b.checked88@gmail.com01062702236
PRINCIPAL_INVESTIGATORBasma Salem, MD

Assistant Professor Clinical and Chemical Pathology. Faculty of Medicine, Benha University, Egypt

PRINCIPAL_INVESTIGATORDina Abd El hadi, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026