An observational study in Toxoplasmosis, sponsored by Benha University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Benha University · Observational
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.
29 studies on the registry are indexed under Toxoplasmosis; 8 are open to participants now.
This study's planned enrollment of 55 is below the median of 100 across 10 observational studies indexed under Toxoplasmosis.
Browse Toxoplasmosis studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Seropositive for T. gondii IgM (indicating acute infection).
Refusal to participate.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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).
Time frame: 2-3 Months
Started Nov 2025 (actual). Primary completion is estimated for Feb 2026, 3 months after the start.
How these figures are worked out, and which studies are left out of them.
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