Blood microRNAs to distinguish schizophrenia, depression, and bipolar disorder in women with chronic toxoplasmosis
Official title: Deciphering The Role of Circulating MicroRNAs To Differentiate Psychological Disorders Among Women With Chronic Toxoplasmosis
Run by Benha University · NCT07346833 · Data updated 2026-11-12
This project will test whether specific blood microRNA levels can help tell apart schizophrenia, major depression, and bipolar disorder in women with long-term Toxoplasma gondii infection.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 55 (estimated) |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banhā, El Qalyoubia) |
| Status | Recruiting |
| Started | November 20, 2025 |
| Main results expected | February 2026 |
| Study ends | April 2026 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT07346833 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women who have a DSM-5 diagnosis of schizophrenia, major depressive disorder, or bipolar disorder, who are not acutely infected with T. gondii (IgM negative), and who can give informed consent are ideal candidates.
✕Probably not a fit
Men, people with psychiatric diagnoses outside the three specified disorders, those with acute T. gondii infection (IgM positive), or anyone unwilling to provide blood samples are unlikely to receive direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational project enrolls women diagnosed by DSM-5 with schizophrenia, major depressive disorder, or bipolar disorder and classifies their T. gondii infection status using serology (IgM negative to confirm chronic infection). Researchers will collect blood samples to measure circulating microRNA expression and compare profiles between patients with chronic toxoplasmosis and those without the infection. The aim is to identify microRNA patterns that correlate with specific psychiatric diagnoses and with chronic T. gondii serostatus. No experimental treatments are administered; data will be analyzed to see if miRNA signatures could serve as biological markers for differentiating these disorders.
Why it matters
Potential benefit: If successful, this work could yield blood-based biomarkers that help clinicians distinguish between schizophrenia, depression, and bipolar disorder in women with chronic toxoplasmosis, potentially guiding more targeted care.
How similar studies have gone: Previous research has linked chronic T. gondii infection to psychiatric risk and has explored circulating microRNAs as potential psychiatric biomarkers, but using miRNA profiles to distinguish specific diagnoses in the context of chronic toxoplasmosis is largely novel and not yet validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Benha faculty of Medicine
Banhā, El Qalyoubia, Egypt Recruiting
Study contacts
- Principal investigator: Basma Salem, MD — Assistant Professor Clinical and Chemical Pathology. Faculty of Medicine, Benha University, Egypt
- Study coordinator: Heba Abo El Ela, MD
- Email: b.checked88@gmail.com
- Phone: 01062702236
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating the prognosis of severe toxoplasmosis in ICU patients
This study looks at how well different treatments work for patients with severe toxoplasmosis in the ICU, especially those with weakened immune systems, to understand their chances of recovery.
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Treating congenital toxoplasmosis with specific medications
This study is testing the best way to use a combination of medications to treat congenital toxoplasmosis in infants and also looks at treating infected fetuses in pregnant women.
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Characterizing cerebral toxoplasmosis in non‑HIV immunocompromised adults at Strasbourg University Hospital.
This project will collect clinical information on adults with weakened immune systems (excluding HIV) who have cerebral toxoplasmosis to see which diagnostic methods, treatments, and preventive steps work best.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.