Role of Circulating MicroRNAs in Differentiating Psychological Disorders Among Women With Chronic Toxoplasmosis

NCT ID: NCT07346833

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Toxoplasmosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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T. gondii Seropositive Group

Women with diagnosed psychiatric disorders (Schizophrenia, MDD, or Bipolar Disorder) who test positive for anti-Toxoplasma IgG antibodies, indicating chronic infection.

Circulating miRNA Expression and T. gondii Serology

Intervention Type 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.

T. gondii Seronegative Group

Women with the same diagnosed psychiatric disorders who test negative for anti-Toxoplasma IgG antibodies

Circulating miRNA Expression and T. gondii Serology

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Heba M. Aboelela

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Basma Salem, MD

Role: PRINCIPAL_INVESTIGATOR

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

Dina Abd El hadi, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Benha faculty of Medicine

Banhā, El Qalyoubia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Heba Abo El Ela, MD

Role: CONTACT

01062702236 ext. +2

Facility Contacts

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Hesham Rashid, Professor

Role: primary

101 497 7666 ext. +20

Other Identifiers

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RC 10.10.2025

Identifier Type: -

Identifier Source: org_study_id

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