Blood microRNAs to distinguish schizophrenia, depression, and bipolar disorder in women with chronic toxoplasmosis

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

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
• Enrollment: 55 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Benha University (Academic / other)
• Locations: 1 site (Banhā, El Qalyoubia)
• Trial ID: NCT07346833 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Banhā, El Qalyoubia

• 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

Conditions Toxoplasmosis