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Non-Coding RNAs Gene Expression in Psychiatric Disorders (PsiRNA26)

18 juin 2026 mis à jour par: Carmen Concerto

Gene Expression Analysis of Non-coding RNAs in Psychiatric Disorders

This study aims to investigate whether specific non-coding RNAs, molecules involved in the regulation of gene expression, are altered in individuals with psychiatric disorders such as schizophrenia, bipolar disorder, major depressive disorder, panic disorder, and obsessive-compulsive disorder. Researchers will compare the expression levels of these molecules in patients who are drug-naïve or have been free from psychiatric treatment for at least six months with those observed in healthy volunteers.

The study will also evaluate whether the expression of these non-coding RNAs changes after approximately five months of standard psychiatric treatment. Blood samples collected during routine clinical care will be used to measure the expression levels of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR), a laboratory technique used to assess gene expression.

This is an observational study and does not assign specific treatments. All therapies will be prescribed according to standard clinical practice.

The main objective is to determine whether alterations in non-coding RNA expression may serve as biological markers of psychiatric disorders and whether these markers may help monitor treatment-related changes over time. The findings may contribute to a better understanding of the biological mechanisms underlying major psychiatric disorders and support the future development of more accurate diagnostic and therapeutic approaches.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a multicenter, prospective, observational case-control study designed to evaluate the expression of selected non-coding RNAs in psychiatric disorders. The study will include adult drug-naïve or drug-free patients diagnosed with Bipolar Disorder type I or II, Panic Disorder, Major Depressive Disorder, Obsessive-Compulsive Disorder or Schizophrenia, as well as healthy volunteers recruited from transfusion services.

Patients will be assessed at baseline (T0) and again after at least five months of pharmacological treatment (T1). Healthy controls will be assessed at baseline only. No treatments will be assigned for the purposes of the study. All pharmacological therapies will be prescribed according to routine clinical practice.

Peripheral blood serum samples will be collected from patients and healthy controls. For patients, residual peripheral venous blood collected during routine laboratory investigations will be used for study purposes. Serum samples will be centrifuged, stored at -80 °C, and subsequently transferred on dry ice to the Cellular and Molecular Biology Laboratories of the University of Messina.

Total RNA will be extracted from serum samples and reverse-transcribed into cDNA. Expression levels of selected miRNAs and lncRNAs will be analyzed using RT-qPCR. Relative expression levels will be quantified using the 2^-ΔΔCt method.

The study aims to identify possible ncRNA expression abnormalities in major psychiatric disorders, evaluate treatment-related changes over time, and explore the potential role of ncRNAs as biomarkers for diagnosis and treatment monitoring.

Type d'étude

Observationnel

Inscription (Estimé)

384

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Italie
    • Sicily
      • Catania, Sicily, Italie, 95123
        • Psychiatry Unit, Via Santa Sofia 78
        • Contact:
        • Sous-enquêteur:
          • Dr Fabrizio Bella, MD
        • Sous-enquêteur:
          • Professor Antonino Petralia, PhD, MD
        • Sous-enquêteur:
          • Professor Carmen Concerto, PhD, MD
        • Sous-enquêteur:
          • Dr Ludovico Mineo, PhD, MD
        • Sous-enquêteur:
          • Dr Lucia Basile, MD
        • Sous-enquêteur:
          • Professor Cinzia Santa Di Pietro, PhD
      • Enna, Sicily, Italie, 94100
        • Psychiatry Unit, Contrada Ferrante SNC
        • Contact:
      • Messina, Sicily, Italie, 98125
        • Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1
        • Contact:
          • Professor Angela D'Ascola, PhD
          • Numéro de téléphone: +39 090 221 3389
          • E-mail: adascola@unime.it
        • Sous-enquêteur:
          • Professor Michele Scuruchi, PhD
        • Sous-enquêteur:
          • Professor Salvatore Campo, PhD
        • Sous-enquêteur:
          • Professor Giuseppe Maurizio Campo, PhD
        • Sous-enquêteur:
          • Dr Angela Avenoso, PhD
      • Messina, Sicily, Italie, 98125
        • Psychiatry Unit, Via Consolare Valeria 1
        • Contact:
      • Palermo, Sicily, Italie, 90127
        • Psychiatry Unit, Via del Vespro 129
        • Contact:
        • Sous-enquêteur:
          • Dr Giovanna Marrazzo, PhD, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The study population will consist of adult psychiatric inpatients and day-hospital/day-service patients recruited from the Psychiatry Units of the University Hospitals of Catania, Messina, Palermo, and the Psychiatry Unit of Umberto I Hospital in Enna. Eligible participants will include drug-naive or drug-free subjects diagnosed with Bipolar Disorder type I or II, Major Depressive Disorder, Panic Disorder, Obsessive-Compulsive Disorder, or Schizophrenia. Healthy controls will consist of volunteer blood donors recruited from the transfusion services of the participating university hospitals.

La description

Inclusion Criteria (patients):

  • Age between 18 and 55 years;
  • Male sex or female sex in the mid-luteal phase of the menstrual cycle;
  • Clinical presentation consistent with diagnostic criteria for:
  • Bipolar Disorder type I or II,
  • Panic Disorder,
  • Major Depressive Disorder,
  • Obsessive-Compulsive Disorder,
  • Schizophrenia;
  • First diagnosis and drug-naive status, or absence of psychopharmacological treatment for at least 6 months prior to enrollment.

Inclusion Criteria (Healthy Control):

  • Age between 18 and 55 years;
  • Male sex or female sex in the mid-luteal phase of the menstrual cycle;
  • No treatment with psychotropic medications;
  • Absence of clinical elements supporting a diagnosis of Bipolar Disorder, Panic Disorder, Major Depressive Disorder, Obsessive-Compulsive Disorder, Schizophrenia;
  • Absence of clinical or laboratory evidence of infectious or internal medicine diseases;
  • Absence of autoimmune diseases;
  • HAM-D score < 8;
  • MRS score < 11;
  • Y-BOCS score < 7;
  • BPRS score = 18;
  • No significant stressful life events during the previous 6 months.

Exclusion Criteria (patients):

  • Current immunosuppressive, antibiotic, or hormone replacement therapy;
  • Relevant medical comorbidities, including autoimmune or internal medicine disorders;
  • Active infectious diseases or infections resolved less than 3 weeks before enrollment;
  • Relevant psychiatric comorbidities;
  • Current psychopharmacological treatment or discontinuation of psychopharmacological therapy less than 6 months before enrollment.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Major Depressive Disorder Cohort
Drug-naïve or drug-free patients diagnosed with Major Depressive Disorder, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).
Génétique: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
Schizophrenia Cohort
Drug-naïve or drug-free patients diagnosed with Schizophrenia, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).
Génétique: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
Obsessive-Compulsive Disorder Cohort
Drug-naïve or drug-free patients diagnosed with Obsessive-Compulsive Disorder, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).
Génétique: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
Panic Disorder Cohort
Drug-naïve or drug-free patients diagnosed with Panic Disorder, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).
Génétique: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
Bipolar Disorder Cohort
Drug-naïve or drug-free patients diagnosed with Bipolar Disorder type I or II, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).
Génétique: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
Healthy Control Cohort
Healthy volunteers without current psychiatric disorders or psychotropic medication use, assessed at baseline only.
Génétique: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders
Délai: Baseline (T0)
Assessment of relative expression levels of a predefined panel of circulating non-coding RNAs (miRNAs and lncRNAs) in peripheral blood serum of drug-naive/drug-free psychiatric patients compared with healthy controls, using real-time PCR (RT-qPCR) and quantified through the 2^-ΔΔCt method.
Baseline (T0)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in Non-Coding RNA Expression After Pharmacological Treatment
Délai: Baseline (T0) and 5 months (T1)
Evaluation of changes in expression levels of circulating non-coding RNAs in psychiatric patients after at least 5 months of standard pharmacological treatment, comparing baseline (T0) and follow-up (T1) samples through RT-PCR analysis.
Baseline (T0) and 5 months (T1)
Differences in ncRNA Expression Between Psychiatric Patients and Healthy Controls
Délai: Baseline (T0)
Comparison of expression levels of ncRNAs involved in synaptogenesis, synaptic plasticity, glial activation, and stress-response pathways between psychiatric patients at baseline and healthy control subjects.
Baseline (T0)
Differences in ncRNA Expression Between Manic and Depressive Episodes in Bipolar Disorder
Délai: Baseline (T0)
Evaluation of differential expression of selected ncRNAs in patients with Bipolar Disorder during manic episodes compared with depressive episodes at baseline assessment.
Baseline (T0)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Carmen Concerto

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 septembre 2028

Achèvement de l'étude (Estimé)

1 septembre 2028

Dates d'inscription aux études

Première soumission

10 juin 2026

Première soumission répondant aux critères de contrôle qualité

10 juin 2026

Première publication (Réel)

16 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 10/2026/CL-PAR

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data (IPD) will not be shared.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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